Our client, based in Co. Waterford, is looking for a Process Engineer – Product Supply. Reporting to the Product Supply Team Lead, you will play an integral role within the Product Supply Unit’s team, ensuring reliable supply of syringe and vial products to our patients globally. The Product Supply APU consists of multiple platforms for the PFS inspection, assembly, labelling, cartoning, of autoinjectors and prefilled syringes and vials. The platforms range from manual processes through to high‑speed, high volume automated production lines. Duties Provide process engineering support to the Product Supply APU. Support delivery of continuous improvement projects to existing equipment. Work closely with various departments, such as MSAT, Technical Development, Quality Assurance, and Supply Chain. Utilisation of knowledge gained from existing manufacturing technologies to aid in the development of new technologies with the goal of implementing higher output and yield. Ensure safety compliance, providing technical and engineering support for process and equipment failures, identifying, and implementing process and product improvements, supporting qualification of new products/processes, analysing machine performance data, and managing improvement projects within budget and time constraints. Support new product introductions and capacity expansions, including new vendor selections, maintenance planning, design changes, change controls, OEE improvement, yield improvement, etc. Lead systematic technical root cause investigations. Support all company safety and quality programs and initiatives. Qualifications and Experience Experience in a highly regulated GMP environment. Degree in an Engineering discipline. Strong problem solving and communication skills. Strong documentation/protocol generation and execution skills. Strong data analysis experience with equipment and integrated systems is desirable. #J-18808-Ljbffr
Prochem Engineering is seeking a Construction Manager to oversee civil and structural projects in Co. Waterford. This role involves ensuring safety compliance, managing quality control, and liaising with stakeholders. Candidates should possess an engineering degree and relevant experience, particularly in pharmaceutical environments. Strong communication, leadership, and interpersonal skills are essential for success in this position. #J-18808-Ljbffr
Overview Our client, a pharmaceutical company in Tipperary is looking to hire a Validation Project Engineer The Validation Project Engineer is responsible for planning, executing, and managing validation activities to ensure equipment, systems, and processes meet regulatory, quality, and operational requirements. This role supports cross‑functional teams, leads validation projects from concept through completion, and ensures compliance with industry standards and internal procedures. Responsibilities Lead validation projects across equipment, utilities, facilities, and manufacturing processes, ensuring timely and compliant execution. Develop and execute validation documentation, including URS, DQ, IQ, OQ, PQ, risk assessments, and validation reports. Manage project timelines, resources, and deliverables while coordinating with the wider engineering team quality, operations, and external vendors. Ensure compliance with regulatory guidelines (e.g. FDA, GAMP 5) and internal quality systems. Support equipment commissioning, FAT/SAT activities, and process qualification efforts. Analyze validation data, identify trends or issue, and recommend corrective or preventive actions. Contribute to continuous improvement initiatives, including process optimization and standardization of validation practices. Ensure that engineering, qualification and validation records are developed and maintained as per cGMP and GDP requirements Develop lifecycle activities including device innovation, concept generation, design reviews, specification development, device industrialization, manufacturing process development, validation and design verification Lead the Equipment Qualification aspects of Projects on site. Perform root cause analysis of Project issues when required. Effectively communicate and discuss related day to day activity and concerns within the team for efficiency and performance improvement Coordinate with design consultants as required and respective user departments for the design/manufacturing of equipment Review and approval on detailed designs as submitted by vendors Ensure project execution work and follow ups with different depts (QA, QM, Operations) to meet project completion within stipulated time frame Qualifications and Experience Level 7 /8 degree in Engineering, Science, or a related technical field. 5+ years of experience in validation, engineering, or quality roles within pharmaceutical, biotech, medical device, or similar regulated industries. Strong knowledge of validation principles, GxP requirements, and risk‑based approaches. Experience with equipment qualification, process validation, and/or computer system validation is an advantage. Excellent project management, documentation, and communication skills. Ability to work independently and collaboratively in a fast‑paced environment. Experience with automation systems, data integrity principles, or digital validation tools #J-18808-Ljbffr
Prochem Engineering is seeking a Validation Project Engineer in Ireland, Munster. This role involves planning and executing validation activities to ensure compliance with regulatory and quality standards. You'll lead cross-functional teams and manage equipment and systems validation projects. Candidates should have a Level 7/8 degree in Engineering or Science, along with 5+ years of experience in regulated industries. Strong communication and project management skills are essential, and familiarity with validation principles is crucial. #J-18808-Ljbffr
Role Summary Our client is looking for a Construction Manager based in Co. Waterford. The Construction Lead / Manager will be responsible for the overview of several projects at the site in Waterford – primarily civil / structural related projects. Core Duties and Responsibilities Proactively ensure a positive safety culture at the site adopting an approach that creates a work environment which delivers on programme whilst working to the highest safety standards. Liaise with all internal and external stakeholders Check and approve (as necessary) submitted documentation Ensure strict deadlines are met. Oversee quality control and safety measures on site – assisting in the development of and ensuring adherence to the PSCS, signing off RAMs etc. Assist in the resolution of unexpected technical difficulties and any problems which arise Ensure all stakeholders are kept informed and up to date. Chairing of meetings and issuing of meeting minutes. Oversee quality control and safety matters on the site and ensure that regulations are adhered to. Supervise sub-contractors Support responses to RFIs as they arise. Minimum Qualifications and Experience Qualification – engineering or other technical discipline – ideally civil / structural background Experience – ideally within a pharmaceutical environment Excellent communication skills Team player with ability to build effective relationships at all levels – with stakeholders Strong interpersonal skills Demonstrates an in-depth knowledge of the construction industry and project execution. Computer literate and familiar with MS office, project, (or similar scheduling package) Good knowledge of safety management and quality management. Ability to lead with confidence, mentor and motivate others. #J-18808-Ljbffr
Prochem Engineering is seeking an experienced PMO Project Engineer to join their new manufacturing site in Co. Kilkenny, Ireland. The role involves leading project management activities for manufacturing lines, collaborating with stakeholders to ensure effective communication of project risks, and overseeing the lifecycle of New Product Introduction (NPI) projects. Candidates should have a Level 7 Degree in a relevant field and a minimum of 3 years of experience. Strong problem-solving and communication skills are essential. #J-18808-Ljbffr
Role Summary: A new opportunity has arisen for an experienced PMO Project Engineer to join our client’s new manufacturing site in Co. Kilkenny. You will be responsible for leading key elements of the program and acting as the program voice for your given workstream. You will also take ownership of the successful implementation of a set of projects that collectively can comprise a program. It will be a very big plus if you can bring experience in New Product Introduction and Line Installation. Core Duties and Responsibilities: Lead/Support the project management activities for a given workstream/manufacturing line. Leading collaboration efforts across key stakeholders to ensure project risks are clearly understood & communicated in a timely manner. Monitor and report on project progress, risks, and issues to senior stakeholders. Facilitate project governance meetings and ensure compliance with PMO standards Driving task & deliverable adherence to established schedule through the daily & weekly Tier meetings Oversee the full lifecycle of NPI projects, from feasibility and design through development, validation, and launch. Developing project plans (incl. scope, objectives, timelines, and resource allocation) & challenging existing program schedules. Build an in depth understanding of your given workstream to drive valuable input to team discussion Lead problem solving workshops to identify program gaps Identify and resolve operational problems to mitigate schedule impact Evaluate and authorize changes that significantly impact the scope, budget, or timeline of the program. Minimum Qualifications and Experience: Minimum Level 7 Degree in Manufacturing, Engineering, Science or related discipline. A minimum of 3 years of experience in a similar role is required. Experience in change management and business transformation project Familiarity with stage-gate or phase-gate NPI frameworks. Experience with portfolio and resource management tools. Ideally, experience working on large capital projects at medical device manufacturing sites Understanding of project lifecycle & how to manage the transition of projects from concept to planning & execution at site level Advanced MS project & MS Excel experience Experience with Manufacturing & Quality documentation. Strong communication and influencing skills. Strong problem-solving skills – ideally evidenced through leadership of workshop style sessions #J-18808-Ljbffr
Prochem Engineering in Ireland is looking for an EHS Specialist on a 12-month contract. This role involves managing all EHS activities for a crucial project in Co. Wicklow. Responsibilities include conducting risk assessments, ensuring compliance with ATEX and GMP requirements, and collaborating closely with various project teams. The ideal candidate will hold a recognized health and safety qualification and have 3-5 years of experience in a similar role within the pharmaceutical industry. #J-18808-Ljbffr
Prochem Engineering is seeking a Project Portfolio Lead to support the Project Portfolio Management group at their biopharmaceutical site in Co. Waterford, Ireland. The role requires managing multiple projects, ensuring stakeholder engagement, and adhering to change control within a GMP-regulated environment. Ideal candidates will possess a degree in Science or Engineering, experience in the biopharma industry, and strong leadership abilities. This position offers an opportunity to impact patient outcomes through effective project execution. #J-18808-Ljbffr
Role Summary: Our client, a leading pharmaceutical organisation is seeking to hire an EHS Specialist on a 12-month contract, on site in Co. Wicklow. The EHS Support Specialist, reporting to the Capital Project Lead, takes responsibility and ownership for all EHS activities associated with the Automation & Electrical Upgrade project. The role is responsible for managing the contractor EHS management program across all construction trades, the project-specific training and induction program, and industrial hygiene monitoring for works within the Plant ATEX classified and GMP production areas. Ensure that incident management, risk assessments, RAMS review, permit-to-work coordination, and corrective action tracking are implemented efficiently across the upgrade project lifecycle. Core Duties and Responsibilities: Review and provide input into all Upgrade Project Risk Assessments, participate in design safety reviews and confirm the formal handover of residual risks from the PSDP to the PSCS/CM is completed and documented before construction begins. Function as the point of contact for day-to-day EHS liaison with the PSCS/CM, monitoring that construction-phase safety obligations are being discharged and escalating any gaps to Project Management. Establish and maintain a structured working relationship with the CM EHS counterpart to co-leading safety walks, co-approving RAMS, jointly investigating incidents, and maintaining a shared compliance tracker across all construction activities. Verify ATEX compliance across all areas including auditing personnel qualifications, spot-checking LEL monitoring, confirming non-sparking tools are in use, and co-approving Hot Works permits with the CM EHS counterpart. Define site-specific PPE requirements for all work areas, conduct regular PPE compliance audits, and intervene to stop work where non-compliance presents an immediate risk. Confirm that all Risk assessment migration actions are reflected in construction-phase RAMS, and ensure any new hazards identified during construction are formally documented and communicated. Co-develop the Contamination Control Strategy with the PSCS/CM and Operations/Quality for GMP areas, defining construction phasing, segregation barriers, cleanroom protocols, and auditing compliance during construction. Review and validate the PSCS/CM permit-to-work system before mobilization, co-approve permits affecting live GMP or utility systems, audit permit compliance throughout construction, and elevate any breaches immediately. Review all working at height RAMS, verify scaffold certifications and inspection tags, confirm rescue plans are in place, and conduct spot-checks on harness inspections, fall arrest systems, and exclusion zones. Maintain the scope of work deliverables across all project phases completing daily Gemba walks, analyzing trends, sharing findings with the CM EHS counterpart for corrective action, and reporting metrics through the EHS Dashboard. Co-lead weekly EHS walking tours with the CM EHS counterpart across all active construction zones, documenting findings with photographs, assigning corrective actions, and escalating non-conformances. Verify that the PSCS/CM implements daily Start Working Meetings for all personnel, attend or review SWM records to confirm hazard communication is adequate, and provide input on site-specific hazards. Support recruitment and onboarding of the EHS resource, ensure baseline coverage is maintained by the site EHS team, and elevate if the CM EHS counterpart or PSCS EHS function is not in place before construction organization. Review existing hazard identification findings (e.g. legacy cable containment assessments) for the building, ensure findings are captured in construction RAMS, and integrate lessons learned from previous capital projects. Review and approve the PSCS/CM traffic management plan for the construction zone, coordinate with Operations to prevent conflicts with active production movements, and audit traffic management compliance during construction. Monitor housekeeping standards across all construction zones through daily Gemba walks and joint inspections with the CM EHS counterpart, ensuring safe walkways are maintained and GMP contamination from construction debris is prevented. Verify emergency preparedness throughout construction to ensure awareness of escape routes, muster points, first aid stations, and eye wash units maintained; Emergency Response Team notified before major lifting or hot work; emergency drills coordinated with the CM EHS counterpart. Attend daily team coordination meetings between CSA, E&I, and Automation contractors, review cross-trade RAMS for safety adequacy, and elevate cross-trade safety conflicts to the PSCS/CM and Project Management. Verify that the PSCS/CM enforces environmental controls for dust suppression, slurry containment, waste segregation and audit environmental permit compliance and waste documentation against site standards. Deliver site-specific induction elements for all construction personnel, verify competence records and ATEX certification before site access, and ensure lessons learned from previous projects are integrated into induction and toolbox talk content. Ensure all incidents and near misses on are reported promptly, co-lead investigations with the CM EHS counterpart including root cause analysis, track corrective/preventive actions to closure, and maintain tracking for all project hours through the EHS Dashboard. Minimum Qualifications and Experience: Essential: Recognized Diploma or Degree in Occupational Health and Safety (e.g., NEBOSH National Diploma, Level 8 Degree in Safety, Health & Welfare, or equivalent). Desirable: Graduate membership of IOSH (GradIOSH) or working towards Chartered status (CMIOSH). Desirable: ATEX awareness certification or formal training in hazardous area classification. Desirable: Manual Handling Instructor (QQI Level 6) or Train the Trainer qualification. Minimum 3–5 years operating in a similar EHS role within the Pharmaceutical, Biopharma, or Life Sciences industry, or other technically complex, highly regulated manufacturing environment. Demonstrated experience working on capital projects or construction phases within a live GMP production facility understanding of construction/operations interface safety. Experience in carrying out risk assessments, RAMS review and approval, and permit-to-work administration (LOTO, hot works, confined space). Proven experience in incident and near-miss investigation, including root cause analysis and corrective/preventive action tracking. Experience in contractor management, induction delivery, method statement review, safety auditing of contractor performance, and non-conformance management. Working knowledge of ATEX zone requirements and construction works within classified hazardous areas. Good knowledge of Irish H&S legislation, in particular the Safety, Health & Welfare at Work Act 2005, Construction Regulations 2013, Chemical Agents Regulations, REACH, and GHS/CLP. #J-18808-Ljbffr
