Purpose This job specification outlines the general responsibilities associated with the role of Senior Associate responsible for QC Metrics and Analytics support. The role will be responsible for providing Metrics reporting and analysis to provide visibility into business processes and implement digital analytics solutions to drive value. Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with their role. Key Responsibilities: Analysing and reporting of QC Business process key performance Indicators Generation of reports required for method tracking and trending and across multiple testing platforms in line with current GMP procedures Fostering a culture of data analytics and data visualisation through sharing of best practices and training of QC staff. Support the definition and advancement of a self-service reporting model. Understanding business needs and developing practical data-driven solutions to meet those needs. Identify, manage and implement data analytics solutions for continuous improvement projects related to laboratory operations. Support to cross functional analytics projects. Building relationships with key business stakeholders, defining user requirements. Championing adaptation of digital technology solutions within a QC lab environment Development activities in SharePoint and Microsoft teams. Liaise with IT teams for troubleshooting activities. Write SQL queries and provide support for routine data pull request tickets. Performing ad hoc data mining and analysis. Exploring and evaluating new digital tools and techniques to advance operational capabilities. Provide support as required for design, build and validation activities related to LIMS downstream reporting application business reports. Knowledge and Experience: Hold a third level qualification in science discipline with 2-5 years experience within a Quality control laboratory Familiarity with common laboratory operations systems, such as LIMS and LMES Excellent Organisational Skills and Time Management. Initiative to explore alternate technology and approaches to solving problems Strong communication skills with the ability to explain complex topics to diverse audiences. High degree of initiative, self-motivation, and ability to work in direct lab teams with a focus on achieving team goals. Ability to identify and manage competing priorities. Proficiency in programming languages, with emphasis on SQL, Python, and/or R is an advantage Experience with data visualisation tools or packages, such as Spotfire, Power BI or Tableau is an advantage Experience with advanced statistical/analytical techniques and machine learning algorithms an advantage is an advantage Seniority Level Associate Industry Pharmaceutical Manufacturing Employment Type Contract Job Functions Science Skills Laboratory Information Management System (LIMS) Analytical Techniques Business Requirements Metrics Reporting Quality Control Key Performance Indicators Data Analytics Digital Technology Laboratory Skills: QC Metrics Data Analytics LIMS QC Lab Experience
We have 4 open positions for a Junior Sustainability Engineer - 1 for each location - Cork, Limerick, Galway and Dublin. Purpose We are looking for A Sustainability Engineer to design, develop & evaluate energy related projects or programs to reduce or improve energy costs & energy efficiency during the designing, building or re-modelling stages of construction. Responsibilities Use IES VE to produce thermal models and simulations relate to a range of building projects to demonstrate regulatory compliance (Building Regulations Part L). Produce energy calculations, heating analysis and generate building thermal loads. Carrying out non-domestic BER assessments, & BER upgrade reports, to enable our clients to achieve A or B rated buildings Provide part L and NZEB advice on a range of our projects Conduct site inspections and energy surveys Design energy retrofit systems Glint and Glare analysis Work with models such as IES Virtual Environment for daylighting, glint, and glare analysis. Qualifications Minimum Degree in Building Services is required - Sustainability/Electrical/Mechanical/Civil-Structural Engineering with further qualifications in Energy/Sustainability. A good understanding of mechanical and electrical services systems and design engineering. Minimum three years experience as a Sustainability. Engineer and ideally in a consultancy environment. 1-2 years experience in Thermal Modelling using IES VE with a solid understanding of MEP services in addition to a general understanding of current Building Regulations including Part L and Part F. Desirable Qualified Domestic / Non-Domestic Building. Energy Rating (BER) Assessor. Experience in NEAP, Daylight, Thermal comfort and Heating and cooling calculations. Experience in Part L compliance calculations for Domestic / Non- Domestic applications Working towards Chartered status or professional membership of Engineers Ireland is desirable. Skills: MEP services Mechanical and Electrical BER
Ideally the successful candidate would be based in Cork, however open to Limerick or Galway also. Purpose We are looking for a Sustainability Engineer to design, develop & evaluate energy related projects or programs to reduce or improve energy costs & energy efficiency during the designing, building or re-modelling stages of construction. Responsibilities Lead and manage full the Energy & Sustainability Engineering for all of our projects, delivered internally and externally, responsible for project performance and profitability whilst always demonstrating Client care. Management, appointment & auditing of subcontractors & their information as appropriate. Co-ordinating dynamic thermal modelling (IESVE) analysis including: Part L Assessments, Comfort Analysis (TM52/59), natural ventilation studies and daylighting. Undertaking & overseeing studies relating to BREEAM Credits including: thermal comfort, low and zero carbon technologies, reduction of emissions, predicted operational energy and daylighting. Leading residential Part L assessments utilising accredited SAP software as partof large scale energy strategies. Preparing Energy & Sustainability Statements for developments to complement planning submissions. This will include coordination and managing energy / sustainability contributions from many different design team stakeholders.? Preparing high quality reports that clearly and concisely communicate the issues involved and the conclusions. The preparation of sustainability and energy strategies will be a core part of the job role. Support bidding for new opportunities including contributions to marketing material and attendance at interviews for projects at a range of scales. Undertaking domestic and/or non-domestic EPCs for new and existing buildings. Lead change in new systems and technologies. Mentor and develop less experienced Engineers. Travel to client and project locations as required to represent the company for meetings / survey / training etc. Ensure that the good name and reputation of the company is maintained and promoted within the industry to enable repeat work. Qualifications Minimum Degree in Building Services is required - Sustainability/Electrical/Mechanical/Civil-Structural Engineering with further qualifications in Energy/Sustainability. A good understanding of mechanical and electrical services systems and design engineering. Minimum three years experience as a Sustainability Engineer and ideally in a consultancy environment. 1-2 years experience in Thermal Modelling using IES VE with a solid understanding of MEP services in addition to a general understanding of current Building Regulations including Part L and Part F. Desirable Qualified Domestic / Non-Domestic EPC Assessor. Experience in SAP, SBEM, IESVE, Daylight, Thermal comfort and Heating and cooling calculations. Working towards Chartered status or professional membership is desirable. Skills: Thermal Modelling Mechanical and Electrical Systems SAP
Purpose The main function of the Member Services Executive is to provide the members of the Credit Union with a service in line with expectations. The main duties of the Member Services Executive are department specific, and you will be required to take direction from the senior member of your team to ensure the teams goals are achieved to a satisfactory manner. This role sits with the Inputting team who look after the processing of member data processing of member payments received from employer deductions, direct debit, current account etc. Responsibilities Provide the members of the Credit Union with a courteous, pleasant and professional service. This can be via the phone, face to face interaction, through our website / email or by providing back-office support. Processing/management of payrolls to include inputting of payrolls, balancing of Payroll and Back up log. Engaging with salary departments. Processing all work in a timely manner as per the policies and procedures set out. Processing and management of members data to include Payroll Deduction forms, Direct debit management, Standing orders, incoming/outgoing eft files (ACREREP),ensuring these are completed promptly and efficiently. Set up and monitoring of budget accounts and budget direct debits, process payments and engage with members to manage same. Manage the applications, card ordering and file processing for PAYAC current accounts. Engage with PAYAC in relation to fraud/member issues. Assisting members with their account management via the phone, via email or the web or via face-to-face interaction, assisting members with Credit Control queries and assisting members with any of the range of services. Provide support, coaching and guidance to peers, in particular, to Member Service Officers in your team who are working towards their MCC accreditation. To support, promote and actively participate in sustainable energy, water and waste initiatives to create a more sustainable, low carbon and efficient Credit Union. Qualifications The successful candidate will be required to have previously satisfied the minimum competency requirements as set out in the Central Bank Guidelines for sales and related activities ( i.e. QFA or CUA or APA in Loans & Savings and Investment or Pathways CU Diploma/ACCUP). A minimum of 2 years working experience in a Financial Institution is required 1- 2 years working experience in a similar role would be an advantage. Knowledge of SCION an advantage. Excellent IT Skills. Excellent administration skills and attention to detail.
This is a 12-month initial contract with a view to extension. Owns projects, equipment, responsible for document drafting and protocol execution Overview: Clean Utilities Commissioning and Qualification (C&Q) engineer for various capital projects. Ensure the C&Q activities associated with various capital projects are completed safely, as per schedule and in compliance with GMP and Quality Requirements. Key Responsibilities: Commissioning & Qualification of Clean Utility Systems and execution of qualification documentation Generation of all C&Q test documents (C&Q Plan/Set to Works/FAT/SAT/IV/FT/C&Q Summary Report Provide technical assistance during investigations and system design. Coordinates and supervises all C&Q activities on their systems. Ensures the C&Q schedule is maintained. Manages Daily C&Q coordination meetings. Responsible for Tracking and Reporting of C&Q status and risks/issues. Ensures Startup of equipment/utilities is completed in a safe and coordinated manner. Assist in the development of User Requirement Specifications (URSs) and Quality Risk Assessment for Equipment and Automated Systems (QRAES). Education / Experience: 6+ years experience in Engineering or Commissioning and Qualification Management Technical qualification at third level or equivalent in Engineering. Extensive knowledge and demonstrated experience managing Commissioning and Qualification for Pharmaceutical / Biotechnology projects preferred Knowledge of safety, GMP and environmental regulatory requirements. Demonstrated strong Communication and Leadership skills. Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes. Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry Familiarity with paperless validation systems. Skills: Clean Utilities Equipment Qualification Documentation
Purpose Our clients facility is expanding with the construction of a cutting-edge Drug Product manufacturing facility featuring high-speed syringe filling lines, formulation, component prep, and inspection capabilities. We are seeking an Operations Program manager to drive the cross-functional execution of operations preparedness with a strong focus on resource & components planning, training and onboarding planning, and procedural systems. This role is also focused on developing and implementing robust processes, systems, and readiness activities aligned with best practices from the company network and industry benchmarks, and ensuring "right-first time", "on-time" and an efficient startup readiness. Responsibilities Lead the operational readiness program plan, incorporating people, process, and procedural readiness from facility design to production start-up. Collaborate with Operational readiness lead and convert the roadmap to a clear project plan with resources and milestones identified. Drive the definition of roles and organizational design for the new facility, ensuring alignment with operational needs and startup milestones. Develop and maintain an integrated readiness timeline, capturing critical path activities including onboarding, training, batch record development, and procedural readiness. Lead the design, development, and deployment of onboarding and training systems to support a high-performing manufacturing team. Oversee the development of procedures, batch record training materials, and training documentation to support GMP operations. Track and report readiness progress, risks, and mitigation strategies to senior leadership and site governance forums. Support resource planning and organizational onboarding activities to ensure timely staffing and readiness of operations teams. The role has potential to evolve into leading and managing end-to-end training plan, partnering with site training functions and functional leaders to ensure execution of both self-learning and trainer-led programs. Facilitate cross-functional collaboration with internal and external stakeholders to embed industry best practices into startup plans and training systems. Qualifications Bachelors degree in Engineering, Science, Manufacturing, or a related field. 3-5 years of experience in biopharma or pharmaceutical operations, including aseptic drug product manufacturing. 5+ years of experience in program or project management, preferably in a startup or facility expansion context. Proven success in leading cross-functional teams and managing complex, matrixed initiatives. Preferred Qualifications: PMP or equivalent project management certification. Experience supporting startup of sterile syringe fill-finish facilities. Familiarity with the companys network or similar global biopharma operations. Knowledge of training systems (e.g., Learning Management Systems) and structured onboarding methodologies. Demonstrated ability to drive cultural and operational readiness through scalable systems and processes. Strong leader with exceptional organizational, planning, and stakeholder management skills. Collaborative and influential across multiple functions. Passionate about building operational excellence through people and process. Energized by startup environments with a hands-on, proactive mindset.
Purpose Our client is looking for a Senior Engineer who can lead change and mentor engineers within their team ensuring best-in-class engineering. As a Senior Electrical Design Engineer you will be expected to have a thorough understanding of the theoretical and practical application of their engineering discipline, and a strong understanding of the other disciplines offered by the company while also leading and managing the full Electrical Design on projects of all sizes. Responsibilities Lead and manage full Electrical Design on projects of all sizes always demonstrating Client care. Provide quality control for Electrical Engineering projects across all offices. Project cost control. Management of both project teams and cross-functional teams within the organisational structure. Travel to client and project locations as required to represent the company for meetings/ surveys/training etc. Liaise and collaborate with other offices for all matters as appropriate. Qualifications & Skills Minimum Degree level in Electrical Engineering 6+ years Building Services Consultancy Design experience. Proven experience in delivering detailed designs through the full design cycle. Expert user of Amtech, Relux/Dialux. BIM experience will be advantageous. Chartership Desirable. A thorough understanding of the theoretical and practical application of their engineering discipline, and a strong understanding of the other disciplines offered by the company. Expert knowledge and experience in the following Electrical design areas: Lighting & Emergency Lighting, Small Power and Data, Fire alarms, CCTV & Intruder Alarms, MV/LV Power Distribution, Containment and BMS. Excel at working on several projects simultaneously and show the ability to prioritise and plan work. Demonstrate a good understanding of other building disciplines in the design and installation of buildings. Excellent attention to detail and interpersonal skills. Ability to lead projects internally and externally and be responsible for project performances, including satisfied clients, profitable projects, and maintaining the companys reputation to enable repeat work. Exhibit leadership qualities while working as part of a team. Ability to make prompt, disciplined project decisions. Commercial Awareness. Benefits: Flexitime Bonus Educational Support Wellness Allowance
Purpose This role requires close collaboration with various departments and offers the opportunity to lead cleaning programs for Upstream and Downstream equipment. Technical and operational knowledge of cleaning validation/verification of upstream and downstream equipment, quality systems and regulatory requirements across multiple health authorities. Knowledge of downstream purification processes such as ultrafiltration is desirable. Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing. Good interpersonal skills coupled with proven ability to work effectively in a matrix organisation and in local group. Ability to drive for results independently and adapt to rapidly evolving priorities. Experience in cleaning validation and cleaning approaches to a multiproduct facility is advantageous. Detail orientated and be proficient at technical writing. Responsibilities Prepare and review relevant cleaning validation documentation including but not limited to protocols, reports, plans, risk assessments, technical/impact assessments. Provide input on cleaning processes and troubleshoot/support cleaning activities related to both commercial operations and new product introduction. Provide support for the technical services team during regulatory agency inspections. Identify operational process improvements using Lean Tools . Assist with the investigation of and operations deviations through the eQMS system, engaging with all relevant personnel and functions as appropriate. Participating in technical projects, inclusive of process optimisation projects. Responsibility for Change Management and Deviation Management. Ability to manage competing priorities to ensure timely delivery of tasks. Qualifications Minimum of three years experience in cleaning validation, preferably in bulk drug substance manufacturing. Experience in lean processing is an advantage. Experience in preparation of routine documentation to GMP standard Experience working with digital tools and applications (MS Office, Adobe etc) Ability to read, comprehend and prepare applicable documentation required Skills: Cleaning Validation Technical Writing GMP Bulk Drug Substance
This is a 12-month initial contract. Purpose Validation Engineer responsible for ensuring that the Validation activities associated with a Syringe Filling Line for a Sterile fill finish facility are in compliance with GMP and Quality Requirements. Responsibilities Generation, execution, review and approval of CQV test Documentation (Factor Acceptance Testing (FAT), Instillation Verification (IVs), Functional Testing (FTs), Site Acceptance Testing (SAT) and Performance Qualifications (PQs) associated with a Syringe Filling Line. Pre-Approve and Post-Approve validation protocols. Input into site Validation Master Plans and Standard Operating Procedures (SOPs) Collate and Report on relevant validation data/metrics. Assist in exceptions and deviation resolution and root cause analysis. Reviews Validation planning documents detailing overall strategy for the project. Reviews and Approves Qualification summary reports (QSR) Generates Validation Summary reports. Assist in the development of User Requirement Specifications (URSs) and Quality Risk Assessment for Equipment and Automated Systems (QRAES) Qualifications 6+ years experience in Engineering or Validation Technical qualification at third level or equivalent in Engineering. Extensive knowledge and demonstrated experience executing Validation activities for Pharmaceutical / Biotechnology projects Experience of sterile / biotech equipment within the pharmaceutical industry is preferred. Knowledge of safety and GMP requirements. Demonstrated strong Communication skills Experience using Paperless Qualification Systems is preferred. Strong understanding of a risk-based approach to commissioning, qualification and validation within the biotechnology industry Skills: Syringe Filling Lines FATs IVs PQs Validation
Purpose A new opportunity with our client has arisen for an experienced Project Manager to join the PMO (Project Management Office/Centre of Excellence). This is a key role in supporting excellence in project delivery and is part of a small local PMO (Project Management Office) team responsible for both leading and governing cross functional projects on site. Responsibilities Project management of selected projects within the sites project portfolio, potential projects could include process improvement, new system delivery and NPI (New Product Introduction) projects in our Drug Product specialism. Lead / Support rapid improvement projects through the application of the most appropriate project execution methodology for the given business challenge (Waterfall, Agile, Scrum, etc). Work with project sponsors at initiation to ensure the project scope is fully defined and understood. Lead project management best practice by partnering with cross functional teams to ensure project execution is to plan. Resolve issues and escalate risks in a timely fashion to the relevant on-site and above-site stakeholders. Qualifications A minimum of 6+ years industry experience with at least 4 of those years working in a project management role. Experienced in the application of project execution methodologies (Waterfall, Agile, Scrum etc). Proficiency in the use of project management tools / software Experienced in leading cross functional matrix project teams Experience in MPS/Operational Excellence Green belt Minimum of a Bachelors degree in Operations Management, Engineering, Science or related field Pharmaceutical industry experience. Desirable Experience & Qualification: Experience in a Vaccines, Biologics or Sterile pharmaceutical manufacturing environment. Project management qualifications (e.g. PMP certification)
