Location - London, UK GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client's needs. We are currently hiring for a QAQC electricians our London based datacenter client. Job Title: QAQC Electrician Locations available: London, UK Sector:Data Center Construction Summary: The QAQC Electrician is responsible for ensuring the quality and compliance of all electrical installations within data center construction projects. This role involves conducting inspections, performing tests, and verifying that all work adheres to relevant codes, standards, and project specifications. Responsibilities: Perform detailed inspections of electrical installations, including conduit systems, wiring, terminations, and equipment. Conduct testing of electrical systems and components to verify functionality, safety, and compliance. Document inspection and test results accurately and comprehensively. Identify and report any non-conformances or deviations from specifications. Work closely with electricians, contractors, and project managers to resolve quality issues. Ensure all work is performed in accordance with relevant electrical codes (e.g., NEC), standards, and safety regulations. Review and interpret electrical drawings, schematics, and specifications. Maintain quality control records and documentation. Participate in project meetings and provide input on quality-related matters. Qualifications: Valid electrician's license or certification. Proven experience in electrical installation, with a focus on quality control. Experience in data center construction is highly preferred. Thorough knowledge of relevant electrical codes, standards, and safety practices. Ability to read and interpret electrical drawings and specifications. Strong attention to detail and a commitment to quality. Excellent communication and interpersonal skills. Ability to work independently and as part of a team. Proficiency in using electrical testing equipment. Job location - Onsite Job Type: Full-time Application question(s): Are you open to working in the UK? Are you authorized to work in the UK? To start the process click the Continue to Application or Login/Register to apply button below.
Sligo Based Role GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client's needs. We are currently hiring for a QC Lab Analyst for our Sligo based client. QC Lab Analyst Overview: The QC Analyst is an integral part of our Quality Control team based out of our Ireland - Sligo site. This role will be responsible for the setup and execution of bioassay product testing and supporting (validation) assays at the Sligo manufacturing site. The role is an individual contributor role, the person must be a self-starter, with significant practical and academic experience in test method/assay development in the biotechnology and/or pharmaceutical industry. The person will require excellent interpersonal skills, the ability to manage their own time, work to deadlines and produce a high standard of quality in their work. Key Responsibilities: - Qualification of new laboratory equipment as required. - Perform GMP compliant and timely transfer of analytical methods. - Generation of necessary documentation to support ongoing operation of the QC laboratory, i.e. procedures, work instructions and protocols. - Completing of training of other analysts test methods to be transferred. - Performs sample analysis in accordance with standard operating procedures (SOPs). - Coordinates the use of external test laboratories when required. - Maintains and where required, imports laboratory reagents, media and supplies. - Conducts laboratory investigations and generates reports in response to invalid assays, deviations, OOS/OOT results. - Initiates and completes CAPAs and Change Controls in accordance with site procedures. - Presents analytical date/trend reports clearly and concisely to management. - Provide out of hours On Call support for Critical Quality Impact Systems. - Ad hoc duties as required. Job Specific Technical, Functional, and Professional Competencies: - A background in Analytical Method Developmment, Validation and/or Statistical Quality Control. - An understanding of GMP, ICH and compendia regulations and guidance's. - Demonstrated ability in leading root cause analysis and effective investigation practices. - Excellent problem solving (facilitation and application of tools), risk management and decision-making skills. - Experience in laboratory based in aseptic techniques. - Excellent collaboration skills. - Excellent attention to details and significant data review experience essential. - Excellent technical writing skills including deviation reports and validation reports. - Effective time management and multi-tasking skills. - Demonstrate ability to drive the completion of tasks, trouble shooting skills and excellent attention to detail. - Excellent communication skills, both verbal & written. - Adaptable and flexible, willing to travel when needed. Essential Education and Experience: - At least 3 years' experience in the biotechnology and/or pharmaceutical industry, with operational experience of quality laboratories and/or new product/assay introductions. - Demonstrated competency in bioassays including polymerase chain reaction (qPCR and RT-PCR) and enzyme linked immunosorbent assays (ELISA) is required. - Experience in immunological assays such as viral titrations and cell-based bioassays is an advantage. - Experience of analytical transfer programs and method development/validation. - Experience in authoring, review and execution of analytical and process validation studies and reports is a must. - Proficient in written and spoken English. - Experience in clean room activity is an advantage. Desirable Education and Experience: - A minimum of an Honours degree in a technical discipline (e.g. biochemistry, chemistry, biotechnology, biopharmaceuticals). A Master degree is an advantage. To start the process click the Continue to Application or Login/Register to apply button below.
Location - Westport, Mayo GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects. Role title - MES Engineer (Senior) - Westport Overview: Maintain the MES (POMSnet) environment; to author and maintain recipes and worksheets for the Westport site. Provide technical guidance and solutioning to other MES Engineers. Act as site escalation point for complex or challenging troubleshooting or recipe design. Provide project management guidance and expertise to the MES function. Responsibilities: Design, create, write and/or make all required changes to MES Recipes, worksheets, equipment and material spec's including phase transition logic Design, create, write and execute, test and validation protocols, risk assessments, and system documentation. Design, create, write and/or make all required changes to ensure cleaning, equipment and product procedures are aligned to MES processes and vice versa. Design, create, write and provide training for all other site personnel on their related MES roles and arrange system access. Participate in MES knowledge exchanges, MES Governance meetings, and manage issues, work-arounds and fixes identified. Liaise with the Global MES on Westport requiring system improvements. Provide support to other MES system users as required to ensure business continuity. Participate in NPI projects from initiation to ensure MES system or hardware requirements are taken into consideration. Keep other recipe authors up to date on MES changes Documentation of all activities in line with cGMP requirements. Requirements: Third Level qualification in suitable manufacturing, engineering or business course and/or suitable experience. A minimum of 7 years authoring experience and has led or was technical lead on multiple implementation projects. Proficient with MES application and configuration rules and requirements including interfacing (preferably POMSnet). Experience of batch processing operations in an FDA/HPRA regulated industry. Strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry. SAP knowledge/experience in MM, PP and IM modules. To start the process click the Continue to Application or Login/Register to apply button below.
Location - Sligo GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects. Responsibilities: Comply with EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 16: Certification by a Qualified Person and Batch Release; Article 47 of Directive 2001/83/EC. Qualified Person is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the Product Specification File (PSF)/Marketing Authorisation (MA) and with Good Manufacturing Practice (GMP) for products manufactured at site. To ensure that products manufactured at site are manufactured in accordance with the relevant GMPs. The Quality Assurance Specialist / Qualified Person (QP) is responsible for the disposition of bulk product manufactured at site as acceptable for release or reject based on the information available relating to the manufacture and testing of the product. To disposition bulk product as acceptable for release, or reject, to ensure patient safety based on the information available relating to the manufacture and testing of the batch. * Requirements: Third level qualification in a science discipline MSc in Industrial Pharmaceutical Science or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC Experience gained in an FDA and EMEA approved pharmaceutical environment. Experience gained within an aseptic processing environment, ideally gained within aquality function. To start the process click the Continue to Application or Login/Register to apply button below.
GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We are hiring Laboratory Validation Engineer's for the Mayo region. Laboratory Validation Engineer: The QC Pharma Department is responsible for the qualification / validation of laboratory equipment, systems and processes utilized for routine operation at Laboratories. The Department is also responsible for the revalidation of critical systems. The role of the Validation Engineer is the ensure customer satisfaction is delivered with each revalidation, validation and project work. All validation activity is to be performed in line with Global Standards, FDA, HPRA and other MPH regulatory requirements. This schedule compliance will be achieved by actively engaging with senior management and the impacted BU's and ensuring all projects can be managed and prioritized as required. Job Responsibilities: Over-see, coordinate, guide and implement the site validation master under prospective, concurrent, and retrospective validation studies in a timely manner, with the relevant engineers. To ensure that all validation requirements are met for any new process, equipment or change to existing process or equipment. To actively work on validation projects, being the departmental point person and completing all associated project documentation in line with current corporate and regulatory expectations. To ensure that all documentation pertaining to each validation study under his / her responsibility is compiled, authorized and filed in a timely and organized fashion. To work with the other validation engineers to achieve compliance by coordinating each validation project assigned. The process involves the review and approval of validation documentation and co-ordination of the validation work 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.) To facilitate the PQR review process / Regulatory Review Process and Laboratory Equipment Review Process as per the current rota's. Keep abreast of current and changing regulatory guidance for the relevant areas of validation that applies. Provide support for audit preparation, direct audit interaction and involvement in audit response. Support and comply with internal EHS requirements, procedures and policies. Ensure continued conformance to the EMS within the department. Achieve the companies stated quality objective through continuous improvement efforts and conformance to quality standards. Attend department and APEX meetings and participation in Quality and Safety initiatives. 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). Education Bachelor's degree required in science based or engineering discipline Key Skills Experience in Pharmaceutical company Excellent project management skills Proficient in use of Microsoft Office suite of programs Critical thinking and problem-solving skills Ability to articulate clearly when dealing with internal and external bodies. Excellent conflict handling skills Expertise in the relevant subject matter areas - example Equipment, Facility, Aseptics, Process, CPV, CSV, Cleaning To start the process click the Continue to Application or Login/Register to apply button below.
Job description GerTEK Project Management & Technical Services are hiring for an experienced QA Validation Professional to join our team. The QA Validation Engineer is responsible for the Coordination / direction and active participation in the validation and qualification of equipment, utilities, processes and software in compliance with clients policies, FDA, European cGMP and GAMP standards. Responsibilities Generation/maintenance/execution of Project Validation Plans and schedules. Generation of validation protocols and final reports to cGMP standards. QA support for validation investigations and implementation of corrective actions. Creation/Review/Approval of various validation and qualification documents Management of validation, exception event, and change control processes. Documenting all activities in line with cGMP requirements. Performing cross training within the team and training of new team members. Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems. Coordinating activities to maximize the effectiveness of all of the team members. Communicating with peers and management regarding activities in the area, including elevation of events or concerns Requirements 2+ years plus validation/Quality experience in sterile/aseptic environment especially in the commissioning and qualification area. 2+ years plus of knowledge of cGMP and regulatory requirements relating to the pharmaceutical / medical device industry Strong communication (written and oral), presentation and troubleshooting skill required Effective interpersonal and organizational skills. Ability to work well both independently and in a team environment. Capable of prioritizing work and multitasking. Job Type: Full-time Work authorisation: Ireland (required) Work Location: In person To start the process click the Continue to Application or Login/Register to apply button below.
Location - Westport, Mayo GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects. PROJECT ENGINEER: The Project Engineer is responsible for safely coordinating and leading projects associated with New Product Introductions, Process Improvements, Automation, Aseptic processing, New Processing equipment with some Facility / utilities modifications to incorporate same. The primary responsibility of the role is to ensure that Projects meet agreed goals/targets on time and on budget. The E&T Engineer reports directly to the Senior Manager of Aseptic Engineering who will give advice and support to ensure the equipment/facility/utilities design and goals/targets are achieved. Responsibilities: Safely coordinate and lead cross functional project teams for the delivery of processing equipment to the site based on planned timelines and scope. Processing equipment would include e.g., Autoclaves, RABS & Isolator Filling machines, LAF units, Compounding skids, Vessels, Containment booths & Stopper processing eq. Writing User Requirement Specifications. Selecting Vendors and completing Vendor evaluation matrix. Writing RCE's, placing orders, Project Management & Design review meetings. Working to the ASME BPE 2019 Standard and relevant ISPE Guidelines etc. Coordination of processing equipment installation and services hook up, working with Equipment Vendors and Engineering personnel. Lead the Project Team participation in Factory Acceptance Testing program. Coordination of all equipment documentation requirements. Commissioning of equipment and Engineering support during qualification. Work with the E&T Senior Manager & System Owner / Project Team. Handover training, coordination of O&M manuals, Spare parts, & PM schedules. Requirements: Education and Experience/Knowledge: Third level qualification in an Engineering or equivalent discipline/experience. Experience of working in Biologics, Pharmaceuticals or Medical device industry. Minimum of 2 to 5 years' experience. Project Management experience with a proven record. Assured self-starter with proven Technical ability. Other requirement (i.e. travel) Undertake any travel that the role may require for design review meeting, build inspections, Factory Acceptance Tests (FAT's) etc. Employment type - Full-time Work location - Onsite (In-person) To start the process click the Continue to Application or Login/Register to apply button below.
Location - Hull, UK GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client's needs. We have multiple projects that we support, and we are looking to add to our team, we are interested in talking to you if you fit the criteria outlined below: Position Overview GerTEK Project Management & Technical Services is seeking an experienced Document Controller to join our team for a Commissioning (CX) Project based in Hull, UK. The successful candidate will play a critical role in managing and maintaining project documentation, ensuring accuracy, compliance, and timely delivery. This role will involve handling test packs, uploading and organizing documents within BIM360, and supporting air balancing documentation processes. Key Responsibilities Document Management: Maintain, organize, and manage all project documentation, ensuring accuracy and version control. Upload, track, and manage documentation usingBIM360in line with project requirements. Ensure all documents are compliant with project standards and regulatory requirements. Test Pack Coordination: Compile, review, and managetest packsfor commissioning activities. Ensure all test pack documentation is complete, accurate, and ready for review by relevant stakeholders. Track the progress and status of test packs, ensuring timely submission and approval. Air Balancing Support: Manage and maintain documentation related toair balancingactivities, ensuring compliance with project specifications. Coordinate with the commissioning team to ensure all air balancing records are up-to-date and accessible. BIM360 Administration: Upload and maintain project documents, drawings, and reports onBIM360. Ensure proper access control and permissions for project stakeholders. Provide support and training to team members on BIM360 usage as required. General Documentation Support: Ensure all project deliverables are properly archived and easily retrievable. Monitor document workflows, ensuring timely reviews, approvals, and submissions. Collaborate with project managers, engineers, and commissioning teams to ensure documentation aligns with project timelines. Reporting and Compliance: Generate and distribute regular reports on document status, test pack progress, and other key metrics. Ensure compliance with project standards, company policies, and industry regulations. Key Requirements Experience: Proven experience in aDocument Controllerrole, preferably within commissioning or construction projects. Familiarity withtest packs, air balancing processes, and commissioning documentation. Experience working withBIM360or similar document management platforms. Skills: Strong organizational skills with excellent attention to detail. Proficiency in document management software, includingBIM360. Ability to manage large volumes of documentation efficiently and accurately. Excellent communication and interpersonal skills to liaise with multidisciplinary teams. Strong problem-solving skills and ability to work under pressure to meet deadlines. Knowledge: Understanding of commissioning processes, particularlyair balancingand related documentation. Familiarity with UK construction and commissioning standards and regulations. Are you an experienced Document Controller ready for a new challenge? We'd love to hear from you. To start the process click the Continue to Application or Login/Register to apply button below.
Sligo Role GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects. PROJECT ENGINEER Responsibilities: To provide Engineering services to the plant, in order to maximise the availability of all Site Process Equipment and Utilities. To manage capital engineering projects within site following the Project Lifecycle approach (typical project value range: anything up to €5 million). To support the engineering teams in controlling uptime of process equipment and optimizing efficiencies both in equipment and process performance. To support the Engineering team with the emphasis on continual operational improvements. To provide process engineering support and technical trouble shooting within the site. To improve the operations and reliability of equipment and processes by the successful identification and implementation of continuous improvement initiatives. To manage the execution of projects within the engineering group including specific Process Safety Projects. To support the provision of process safety initiatives to the site. To liaise with Production to ensure equipment performance is maximized. To liaise with Internal/External Engineering Personnel and contract maintenance providers in maintaining, troubleshooting and installing/commissioning equipment. To provide engineering support and technical trouble shooting to all site operations and reliability of equipment and processes by the successful identification and implementation of continuous improvement initiatives. Leadership of process equipment commissioning and validation activities. Identification and project management of continuous improvement projects. Work closely with all site functions and other departments to deliver these continuous improvement projects. Preparation of feasibility studies and budget management for all assigned projects. Management and negotiation of external contracts and contractors. Support all major site initiatives and sites core goals. Requirements Degree in a relevant Engineering Discipline (Mechanical/Chemical/Process) Experience in API Manufacturing / OSD Manufacturing / BioPharm Proven track record in delivering Capital Projects - new equipment, utilities, facilities, etc. Good knowledge of change control and C&Q processes/execution. To start the process click the Continue to Application or Login/Register to apply button below.
Sligo Based Role GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client's needs. We are currently hiring for a CQV Engineer for our Sligo based client. CQV Engineer Key Responsibilities: Commissioning & Qualification of new aseptic manufacturing equipment Writing and execution of qualification documentations such as: FAT, SAT, IOQ, PQ protocols Provide Support for the development of URS and Functional Specification associated with asepctic processing Provide technical assistance during investigations or process/equipment Ensures on-time execution of the schedule and reports Ensures Periodic Review plans are completed per site & regulatory requirements Collaborates with various departments/teams in development and execution of validation activities associated with new equipment/product introductions and process improvements. Ensures validation activities are managed in conjunction with all company and regulatory requirements (Health & Safety, cGMP, construction, environmental etc.). Provide change control assessments which could impact the validated state of process equipment. Leading Risk assessments, root cause analysis and investigations as applicable. Own departmental SOPs and ensure they follow corporate standards and applicable regulations Equipment: Single Use Equipment, Mobile Equipment - SUM/TCU/Utility Panels/Reactor Facility Qualification OR Fine Line (Vial / Syringe ) / Lyo /Capper / External Vial Washer Qualifications Previous experience in execution of asepctic equipment/qualification/asepctic processing Advanced knowledge of FAT, SAT, IOQ Risk - based verification Previous experience on Kneat/online validation package We offer competitive compensation packages and opportunities for professional growth in a dynamic and innovative work environment. If you are a motivated CQV Specialist seeking an exciting challenge in the biopharmaceutical industry, we encourage you to apply. To start the process click the Continue to Application or Login/Register to apply button below.
