Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description Purpose: The Aseptic Manufacturing Technical Lead role will report to the Director of Aseptic Manufacturing. The Aseptic Manufacturing Technical Lead acts as a technical SME for aseptic processes within the Network Aseptic Manufacturing Global team. The position is responsible for supporting troubleshooting for significant aseptic events within the network by providing hands-on assessments and investigation support. The technical lead will drive standardization by implementing and continually updated aseptic best practices based on events and technological advancements. Acting collaboratively with the sites organizing and executing improvement events that proactively identify, quantify, prioritize & mitigate aseptic risks. The position will working with sites, aseptic global team, and aseptic training to partner in development and roll out of aseptic training and mentoring for operations leadership in good aseptic processing. Responsibilities: Provide onsite support for investigation for significant aseptic events within the network by providing hands-on assessments and investigation support. Proactively mentor, advise, and share best practices with network team members, site peers and senior management. Contribute to the development of Aseptic Manufacturing long range strategy and planning and generation of capital plans. Organizing and executing improvement events at manufacturing sites that proactively identify, quantify, prioritize & mitigate aseptic risks within the sites. Acting collaboratively with the sites to drive standardization by implementing and continually updated aseptic best practices based on events and technological advancements. Participate in aseptic auditing by comparing procedures to actual, day-to-day on the floor practices, identifying aseptic risks, and facilitate solutions for mitigating those risks. Participate in identifying, reporting, and tracking site/network aseptic metrics to drive best in class aseptic performance. Qualifications Technical bachelor's degree in Engineering or Science preferred, with other degrees and demonstrated experience with aseptic manufacturing acceptable. Minimum 7 years of manufacturing experience within an aseptic manufacturing environment. Must have depth and breadth of knowledge with equipment, process, and technique as related to sterile manufacturing. Demonstrated ability to mentor and influence outside of direct reporting relationships. Balanced understating between Quality, Compliance, and Manufacturing concerning non-conformity event impact, project capital/expense generation, etc. Must have demonstrated knowledge of regulations and standards for aseptic manufacturing and application to a manufacturing environment. Ability to problem solve, initiate, and manage projects with demonstrated ability to effectively escalate competing priorities and communicate to applicable stakeholders. Must have demonstrated organizational and planning skills and excellent verbal and written communication skills. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description AbbVie helps people around the world live better days and better lives each year. And that takes all of us. We are currently recruiting for an Executive Assistant to support the Vice President of External Manufacturing and a number of members of the External Manufacturing Team in Westport, Co. Mayo for an initial 12 month fixed term contract. This role contributes added value through streamlined processes, effective communication, and meticulous attention to detail, aiming to foster a collaborative and well-organized work environment. In this role you will be managing calendars, coordinating meetings and events, and overseeing coordination for internal and external engagements, the position ensures the teams can focus on strategic decision-making and leadership. If great benefits, a defined career path, and work-life balance are important in your next career move, then read on to find out more: Key activities you will perform in the role: Supporting the Vice President External Manufacturing and team members with Calendar management. Managing the day-to-day operations for their respective Leadership Team (LT). Coordinating the activities of the LT including scheduling and agenda management of relevant LT meetings, collecting and distribution of LT metrics, and management of action items and accountability, producing site reports, presentations and highlight updates. Attend LT meetings occasionally to align metric reporting. Coordination of communication at all levels, email updates, supporting updates of digital screens on sites where security messages are prevalent working with our Comms leads. Coordinating LT events, off-site training and team building activities as directed. Lead the co-ordination and agenda of important/VIP internal and external visitors, including Accommodation, transport, meeting rooms, catering, and restaurant bookings. Manage the meeting rooms booking system. Schedule flights, accommodation and car hire for Vice President External Manufacturing and team members. Requisition of e-Carts for PO's for LT functions including order creation and payments. Qualifications The educational background and preferred experience we look for: Third level qualification in Business or related discipline is preferred 3-5 years experience in a similar role, ideally in a multinational environment Experience working with MS Office (including PowerPoing) is required Fast and effective typing skills, good organizational skills, excellent communication abilities and interpersonal skills. Ability to handle confidential information with integrity Ability to demonstrate a proactive approach to duties Fluent English required. French would be desirable So, does this all sound like the right role for you? Then apply now and join AbbVie today! Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The NPI Launch Site lead will report to the Director of the Tech Center business unit and be responsible for the Site New Product Introduction Programs. This position has responsibility for providing direct oversight, management, and leadership with minimal technical or administrative guidance, as well as responsibility for all aspects of technical process support such as but not limited to project management, process monitoring and validation programs within the site. This includes leadership of in-line product support for processes, project definition and demonstration, and process improvements/productivity while assuring compliance with regulatory agencies. These activities involve economic feasibility studies toward objectives assigned or approved by site leadership. Main duties & responsibilities: Lead personnel (team of 7-9) responsible for New Product Introduction Programs of the site for Biologics. Drive Drug Product Technology transfers to manufacturing, including the financial aspects of each project. Provide technical guidance and continuous improvement support for commercial and new product introductions on day-to-day production and processing issues: problem solving, deviations, manufacturing documentation changes, etc. Source for plant consistency across the Division, share problem-solving activities, and maintain updated technical product history. Provide technical assistance with the implementation of changes in manufacturing equipment, batch size, ingredient supplier and experimental batches as needed. Ensure that products and processes are kept in compliance with validation requirements. Identify and solve technical problems independently for new products and for commercial operations. Plan data collection organizes results and applies statistical methodology. Presents numerical information through computer readouts, graphs, charts and tables, written reports and/or other methods. Evaluate new process equipment and advises management about areas of opportunity in the application of novel technologies. Implement at plant level global technical initiatives as: new technologies, suppliers, methods, etc. and provide tactical perspectives. Assure fulfilments of environmental, health, and safety (EH&S) requirements and compliance obligations, promote continuous improvement, and consider EH&S aspects during the design and change process. Qualifications M.Sc. in a relevant Science area and extensive experience in a "hands on" Process Engineering or development for new product introduction position. Experience of managing and leading professional teams that include Engineers and or Scientist personnel. Experience leading product transfer and New Product Introduction projects. Regulatory filing experience as well as familiarity with HA audits. Excellent communication and interpersonal skills for interaction with both internal departments and other AbbVie sites worldwide (QA, Validation, IS, EHS, R&D, S&T). Computer literate with knowledge of statistical methods, data assimilation and interpretation. Capable to positively influence department employees and/or contributors from other disciplines or peers of higher managerial levels to obtain decision approvals for critical courses of action, either exception or planned. Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description We have an exciting opportunity for a Site Security Manager to join our team in Westport, Co. Mayo. The position reports to the Regional Security Director, Manufacturing Security, Europe. The Site Security Manager will serve as the primary point of contact for all security-related issues at AbbVie manufacturing facilities in Westport. The successful candidate will be responsible for ensuring full compliance with AbbVie's Global Security standards and policies. The Security Manager oversees and implements the site's security program to safeguard personnel, property, information, and products, helping to maintain a safe and compliant operating environment. Establish and manage relationships with Abbvie site leadership and crisis management teams. Act as the main POC for the business with the third-party security contractor carrying out guarding duties on site, overseeing performance standards and KPI adherence. Establish and manage relationships with security integrators and vendors, ensuring service level agreements (SLAs) are maintained. In close coordination with the Regional Security Director, develop, implement, and maintain the site physical security program to protect company assets, including access control, surveillance systems, and crisis response procedures. In close coordination with the Regional Security Director coordinate training drills and simulations/Tabletop exercises (TTXs) to ensure all personnel and CAT members are prepared for various crisis situations. Liaise with local authorities, emergency services, and other relevant agencies to foster effective communication and collaboration. Prepare for and support inspections by government and non-government agencies and foreign regulatory bodies. Ensure all security measures and documentation are up-to-date and comply with regulatory standards. Ensure security teams are properly prepared to receive such visits/inspections. Collaborate with site leadership and stakeholders to create and maintain a comprehensive business continuity plan that ensures minimal disruption during emergencies, business disruptions or significant incidents. Conduct thorough investigations of security incidents, breaches, and irregularities, documenting findings and recommending corrective actions. Lead and manage Site security-related capital investment projects, including upgrades to security technology, new security installations, and facility assessments. Assist in the development and management of the security budget, ensuring cost-effective measures are implemented and vendors are providing value for money. Conduct thorough risk assessments and security audits to identify potential security threats and develop strategies to mitigate those risks in close coordination with the wider global security team. Coordinate the inputs of Global Security branches as they support the designated site- acting as the conduit between specialized Global Security functions and the site team where necessary. Undertake tasks allocated by the Regional Security Director which support the overall security program in the region, including the review, enhancement and certification of existing protocols and security procedures both regionally and centrally. Lead and manage the on-site security staff: oversee recruitment, onboarding, training, scheduling, supervision, and performance assessments in close coordination with the site supervisor from the providing vendor. Qualifications Certified qualifications relevant to the position or equivalent are required. Bachelor Degree and Certification in security management (e.g., ASIS Certified Protection Professional (CPP), Physical Security Professional strongly preferred. At least 5 years of progressive leadership experience in corporate security, law enforcement, or a related field. Knowledge of the pharmaceutical industry is preferred. Must demonstrate strong management and leadership presence, and ability to lead a team. Demonstrated expertise in physical security principles, crisis management, and practical risk assessment in a corporate, pharmaceutical, or critical infrastructure environment. Advanced knowledge of security technology, including access control systems, video surveillance (CCTV), intrusion detection systems, and the implementation or upgrade of security systems. Advanced communication skills, both verbal and written with the ability to effectively influence and collaborate with cross-functional teams and senior management. As the role is part of a Global Team and involved cross-regional collaboration, a high standard of spoken and written English is also expected. Strong knowledge of physical security principles, crisis management practices, and experience in delivering tabletop exercises and security training programs to enhance awareness and preparedness. Familiarity with compliance requirements related to relevant government agencies in country of deployment is preferred. Team player with the ability to collaborate effectively across cross-functional teams, navigate a matrixed organizational structure, and build relationships in a multinational and multicultural environment. Demonstrable experience and skills in the development and roll-out of security protocols & SOPs preferred. Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description We are seeking a highly organized and proactive Quality Control Laboratory Planner to join our Quality Laboratory team at AbbVie in Westport on a 12 month fixed-term-basis. As a QC Laboratory Planner, you will be responsible for the planning and control of the testing schedule for all Westport manufactured products. This role involves preparing both short-term and long-term testing schedules, incorporating non-routine testing needs such as process validation, customer complaints, and non-conformance testing. Key Responsibilities: Coordinate with various stakeholders including Planning Manager, Supply Chain Planners, Operations, and QA to ensure timely testing and release of results. Develop and maintain short-term and long-term testing schedules, collaborating with the QC team and site stakeholders. Host and chair the weekly QC Release meeting, and issue weekly QC testing schedules to stakeholders. Work closely with QC Supervisors to develop training matrices, ensuring optimal coverage, cross-training, and resource capacity in the QC laboratory. Ensure instrumentation availability and utilization in support of testing schedules. Analyze data for improvements in workflow, testing capabilities, and efficiencies, reporting laboratory performance metrics regularly. Serve as the key contact within the QC department for updates on testing status and schedule changes. Perform additional duties as directed by QC Managers and Senior Management. Qualifications Bachelor's degree or above in Chemistry, a related science, or a planning and scheduling discipline. Minimum of 3-5 years of related pharmaceutical experience (QC, Manufacturing, Supply Chain, QA, etc). Experience in planning or scheduling within a QC laboratory environment is advantageous. Proficiency in Microsoft Office Suite and understanding of Lean Manufacturing concepts. Strong time management, organizational, and project management skills. Excellent communication skills, with the ability to build and develop strong cross-functional relationships. Ability to positively influence a wide range of stakeholders to achieve optimal testing schedules. Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description Do your best work at AbbVie-as part of a brilliant, curious team We are currently sourcing an experienced Maintenance Fitter to join our team in AbbVie Westport on a permanent basis. This is a shift based role, you will be required to work Weekend 12-hour shifts between days and nights on a bi-weekly rotation. The Business Unit (BU) Maintenance Technician (Fitter) reporting to the Technical Lead will work as part of the technical team across aseptic manufacturing and Filling, Packaging, Plastics and site services. They will work to key metrics in equipment up time, Health & Safety, Quality/Compliance, Customer Service (internal and external) and Cost. Responsibilities: Planned and Unplanned maintenance of mechanical Services, Plant and Equipment. Responsible for determining root cause of equipment issues and implementing solutions Support Machine and Equipment Effectiveness improvements. Identification and sourcing of equipment spare parts. Assisting preventative maintenance by specialist vendors. Attendance during FAT / Commissioning of new plant and equipment. Assist in the performance of equipment qualifications. Support the setup of Preventative Maintenance Routines for equipment. Support the Risk assessment of tasks and equipment. Communication of any concerns about work processes to Management. Resolve technical issues in an effective & timely manner to support operations. Support continuous improvement and process efficiency programs, i.e., MEP, OEE, OPEX, RCA, RCM and productivity output for the BU. Provide information to the tracking and monitoring of the relevant KPIs for the Technical Team. Help support the BU during regulatory and compliance audits. Ensures all maintenance activities within Eyecare are performed to the appropriate health and safety standards. Ability to trouble-shoot and correct technical issues, in an effective and timely manner, with a sense of urgency to minimize equipment downtime. Ability to read, analyse, interpret technical data, and technical procedures. Ability to effectively present information and answer queries. Willingness and ability to collaborate with and influence other groups in a positive, team-based environment. Flexible and willing to carry out overtime and Shift Work as necessary. Qualifications Trade Certified Mechanical Qualification. A minimum of 2 years' maintenance and troubleshooting experience in a highly automated production environment Clear understanding and experience of maintenance and troubleshooting of electrical, mechanical, instrumentation and automation systems. Good documentation skills. Ability to organize workload and work on own initiative. Experience in GMP or other regulated environment and knowledge of required safety standards. Strong ability to evaluate, diagnose and troubleshoot problems. Flexibility to respond to issues outside normal business hours. Ability to learn new and different technologies. Working knowledge of pharmaceutical/biotech industries or aseptic processing. The ability to interpret pneumatic and hydraulic schematics and mechanical specifications Experience in the maintenance of electromechanical manufacturing equipment Machining, and welding experience an advantage Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description AbbVie Ireland is seeking a Senior Quality Compliance Analyst for a 12 month Fixed Term Contract at our Westport site. This role will be central to supporting QA activities relating to one of our combination products, across commercial, clinical, and development operations. The position reports to the Senior QA Manager and interacts closely with the QP and Business Unit Leader to achieve high standards in product quality and regulatory compliance as per EMA, FDA, and relevant regional Ministries of Health. Responsibilities: Collaborate with the Senior Quality Manager to deliver the company's quality plan and ensure compliance with global regulatory requirements. Maintain strong working relationships with management, business units, support functions, and both site and global quality functions; confidently communicate quality requirements. Provide quality input and guidance on daily activities as a contributing member of the site quality team. Coordinate QMS (Quality Management System) management for assigned areas and contribute to overall site quality system overview. Qualifications Bachelor's degree in a science or engineering discipline. Minimum of 5 years' experience in a quality discipline within the Pharmaceutical or Medical Device environment. Demonstrated knowledge of quality standards and regulatory requirements (EMA, FDA, etc.). Proven ability to work as part of internal and external teams to deliver projects. If you are dedicated to ensuring product quality and regulatory compliance and meet these qualifications, we encourage you to apply for this FTC opportunity in Westport. Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description Assist Abbvie in achieving EHS goals by working safely & observing all general plant and departmental safety policies. Perform Daily, weekly and monthly clean as per Department procedures Top up of gown / scrub supplies Perform Monitoring of the Unit Dose Filling area every shift Adhering to good documentation standards when completing documentation Adhere to good aseptic practices within Grade B environment Triple Cleans Perform all assigned duties by the Manager/Line lead in accordance with departmental SOP's and cGMP Remain current on proper procedures by reviewing current, revised and new SOP's relating to the job and the department. Complete and remain current with all required cGMP and safety training. Perform other duties as assigned. Qualifications Experience 2-3 years working in a pharmaceutical environment. Manufacturing/ Cleanroom experience preferable Good computer skills A Keen eye for detail and quality Good communication skills A team player High level of professionalism and focus on the job Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description We are looking for an Associate Director of Automation to join our Engineering Team in Westport. This position reports to the Director, Plant Engineering. This is an exciting time to join our team as we grow and bring new products and technologies to the site. The Associate Director, Automation will be responsible for leading Automation and Operational Technology (OT) systems, ensuring compliance and performance. You will drive key initiatives like electronic Batch Record (eBR) rollout and capital upgrade projects. Roles and Responsibilities Manage and mentor the Automation/OT team, maintaining strategies aligning with site goals. Provide coaching, set performance objectives, and foster team development. Manage a team of 6-8 engineers and coordinate resource planning and growth initiatives. Enhance productivity, cost efficiency, and compliance through systems and processes. Develop software modules and automation solutions for batch manufacturing. Manage system integration, validation, cybersecurity, and support services. Implement emerging technologies and maintain regulatory standards. Design training for end-users and manage vendor relations. Oversee priorities for SCADA, PLC, DCS engineering, and production support. Handle change controls, complex system issues, and long-term maintenance. Drive process optimizations and lead audits in the Automation/OT domain. Responsibility for site Automation/OT compliance and performance. Present technical data for stakeholder decision-making and resolve complex issues promptly. Maintain validated systems and uphold documentation integrity and audit readiness Lead cross-functional strategies, operational efficiencies, and digital transformation efforts. Influence decisions on cost, compliance, quality, and productivity. Qualifications Bachelor's or Master's degree in Mechatronics, Control Systems, Electrical Engineering, or a related area 8-10 years of experience in FDA/HPRA-regulated pharmaceutical or biotech environments. Proven leadership experience in managing projects and people. Strong technical skills in batch processing, SCADA/DCS/PLC integration, and regulatory standards Demonstrated success leading validated systems and major automation upgrades Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description If you want to be a difference maker our people are waiting. See the difference you can make at AbbVie. We are now looking for a Site Process and Cleaning Validation Lead to join our diverse Technical Centre leadership team at AbbVie Westport on a permanent basis reporting into the Director of Technical Centre. In this role you will be responsible for managing and overseeing the validation of manufacturing processes and cleaning procedures at the site (for eyecare, implants, and biologics including toxins) to ensure compliance with regulatory standards and internal quality requirements. As our new Process and Validation lead you will lead validation activities, partner with cross-functional teams, and ensures robust documentation and execution of process and cleaning validation life cycles. Is this a team you want to be part of? Then read on... Key Responsibilities: Develop and execute site validation master plans for process and cleaning validation. Lead the design, planning, and implementation of validation protocols (PPQ), including risk assessments and data analysis during tech transfer. Oversee the review and approval of validation documentation, reports, and change controls. Collaborate with manufacturing, engineering, and quality assurance teams to drive continuous improvement. Ensure compliance with global regulatory requirements (FDA, EMA, etc.) and company policies. Manage validation investigations, deviation reports, and corrective/preventive actions (CAPAs). Train site personnel on validation procedures and best practices. Represent validation function in audits and regulatory inspections. Participate in risk assessment process for all business units & Participate in design review process for all business units. Tracking and generation of weekly metrics (GTW QMS, EHS, Compliance Wire etc.) Provide support for audit preparation, direct audit interaction and involvement in audit response. Participation in site internal and external audit program (to include periodic review). Manage revalidation schedule, regulatory affairs response, laboratory validation documentation review and APR report in conjunction with Business Unit Owner. Coach and Develop (including upskilling as required) direct reports to ensure provision of technical support/leadership to the site. Manage and motivate the employees in the function through effective communication to the management positions and their reports. Hold performance review meetings according to company policy including individual development plans. Maintain staffing in line with business needs including selection and recruitment. Develop and manage the functional budgets to meet company objectives. Manage non-conforming KPIs as required by putting in place robust preventative action plans. Qualifications So, what do you need to excel in this role... Qualifications, Technical Skills and Experience: 9+ Years (Bachelors) or 7+ years (Masters) or 5+ years (Phd) degree in a scientific or engineering discipline (Chemistry, Microbiology, Pharmacy, Chemical Engineering, or related field). 7+ years of experience in pharmaceutical validation (process and/or cleaning). In-depth knowledge of regulatory guidelines for validation (cGMP, FDA, EMA, ICH Q7/Q8/Q9/Q10). Strong project management, problem-solving, and organizational skills. Ability to work collaboratively in a cross-functional environment and manage multiple projects simultaneously. Excellent conflict handling skills Expertise in the relevant subject matter areas -example cleaning, CSV, Aseptics, process, CPV Understanding of Process Validation, Computer system Validation, SCADA systems, CPV, Sterilization, Packaging systems and related technologies. A strong understanding of current data integrity expectations would be a distinct advantage. Excellent communication and presentations skills, both written and oral -ability to present data in a clear and concise manner to team members and where required, to management Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
