Ben Pope

CQV Engineer – Massachusetts – Pharmaceuticals – Contract Our client is a leading American multinational CDMO specializing in the development and manufacturing of complex, highly regulated active pharmaceutical ingredients (APIs). Our client is seeking an experienced CQV/Validation Engineer to contribute to an exciting project in the New England area. What you’ll do: Generate, execute, review, finalize, and approve validation/qualification protocols and reportsManage and update project validation plans for specific projectsAssist and deliver amendments to the qualification(s) to ensure qualification compliance within agreed upon timelines.Utilize computerized asset management system for managing validation/qualification schedulesGenerate operational and maintenance SOPs, FATs, URSs, FRSs, validation protocols and reports What you’ll need: Bachelor’s degree required; B.S. in engineering preferred.Experience in an Engineering or a closely related role in a manufacturing or R&D environment.Experience in a GMP environment required. Experience in the pharmaceutical/API/chemical manufacturing industry preferred.Experience in a Validation Engineering role generating and executing Commissioning, Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) protocols If you are interested, please apply now for immediate consideration and further information. #LI-BP1

Automation Engineer (C&Q Support) - Ireland, Dublin - 12 Months Initial ContractWith more than 2,000 employees, more than 300 million units per year, and a lot of innovative medicines in the pipeline, no wonder our client is one of the largest production units in the world! Our client produces, packs and distributes in a high-tech environment, sterile injectable medicines. More than 1 million injectable medicines are produced, packaged and distributed every day. Their destination: 170 countries, worldwide!  Do you want to work with an exciting company who are an established market leader within their niche field? We have a fantastic opportunity for an  Automation Engineer (C&Q Support) to work on an exciting CapEx project near Dublin on an initial 12 month contract. As  Automation Engineer (C&Q Support) you will play a key role in the successful delivery of a new state of the art facility.What you'll do: Support C&Q team in the shakedown of Equipment Modules, Phase Classes and Recipes on a day-to-day basisTrouble-shoot issues as they arise in the field – determine immediate work arounds where appropriatePropose solutions and prepare Automation Change Packs to remedy issues What you'll need: Qualification in Engineering, Science or a related field‘Hands-on’ experience of Emerson DeltaV DCS system is essentialExtensive experience with experience in a GMP environment, preferably Pharma/BiopharmaStrong problem solving/trouble-shooting skills If this role is of interest to you, please apply now! #LI-BP1

Process Engineer - Belgium, Antwerpen - 12 Months Initial Contract Do you want to be part of a forward thinking global pharmaceutical client who have facilities in over 60 countries worldwide? Then this is the next step for you! One of our global pharmaceutical clients is currently requiring an experienced Process Engineer for their Belgium based location.   What you'll do: Engineering feasibility studies that include scope option analysis to determine best value optionEarly scope development, capital estimate, timings and risk assessmentEarly engineering design support (feasibility and conceptual design)Small molecule (synthesis) technologiesManufacturing and packaging What you'll need: Extensive experience working within similar roles.Experience in engineering feasibility studiesConceptual design experienceExperience developing scopes from an early phase including capital estimate, timelines and risk assessments If this role is of interest to you, please apply now!#LI-BP1

C&Q Project Lead - Belgium, Geel - 12-24 Month Contract Do you want to be part of a forward thinking global pharmaceutical client who have facilities in over 60 countries worldwide? Then this is the next step for you! One of our global pharmaceutical clients is currently requiring an experienced C&Q Project Lead for their Belgium based location.  What you'll do: Lead C&Q efforts as the primary Project Lead for a small molecule site capacity expansion, managing a team of 20+ engineers.Coordinate cross-functional collaboration with Engineering, Automation, Maintenance, Operations, and Quality to define commissioning and qualification requirements, including documentation, risk assessments, and testing strategies.Review technical and vendor documentation (e.g., FAT, SAT, IQ/OQ) with a focus on GMP-critical aspects and compliance with project standards.Develop and execute verification documentation aligned with internal Quality Standards, cGMP, and approved strategies, ensuring integration across systems and equipment.Support project reporting and change control, assisting in status updates, cost estimates, schedules, and managing change control processes effectively. What you'll need: Bachelor of Science in Technical Field (engineering, life science, or equivalent) from accredited institution.Requires extensive experience working within C&Q Project Management.Experience in Small Molecule C&Q projects.Excellent oral and written communication skills, including presentations.Demonstrated ability to interact effectively with all levels of the organisation.Demonstrated understanding of risk-based approach to commissioning & qualification.Experience with testing of automated manufacturing equipment / systems (e.g., Delta V and PLC-controlled). If this role is of interest to you, please apply now!#LI-BP1

OSI PI Consultant - Dublin - 12-month contractDo you want to work with an exciting company who are an established market leader within their niche field? We have a fantastic opportunity for an OSI PI Consultant to join one of our industry leafing clients in Ireland.Responsibilities:  Lead the development and standardisation of engineering work instructions and naming conventions.Manage and optimise AF/EF structures, ensuring comprehensive data integration across systems.Automate event creation and streamline configuration processes to reduce manual dependencies.Support and enhance PI system security, including protocol standardisation and vulnerability mitigation.Contribute to the creation of standardised test protocols for both project and BAU activities.Provide strategic guidance on asset consolidation, including server and network configurations.Evaluate and deploy reporting tools, and support data visualisation using PI Vision and other platforms.Identify opportunities for automated testing and collaborate with internal SMEs.Maintain and improve disaster recovery plans and operational SOPs.Ensure clean and secure PI mappings and manage data replication to development environments.Implement tailored history data recovery methods based on source types.Document integration processes for new equipment and assess training needs to improve delivery. If this sounds like the position for you then please apply today!#LI-BP1

Utilities Project Engineer - Ireland, South Dublin - 12 Month Contract Our client, a globally recognised pioneer in Biotechnology, are recruiting for the position of Utilities Project Engineer. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to join them on their global mission to better the lives of those effected by disease and illness. What you'll do: Project management and execution of assigned projects including project prioritisation, resources management, status management and external communication.Working with various stakeholders, to scope projects and ensure requirements are satisfied. Project input will span from concept, through design, construction, commissioning and operationCoordinating the introduction of new processes, equipment and materials including problem solving and troubleshooting equipment issues prior to qualification & start-upSupporting the development and implementation of maintenance programs and spare parts inventory optimisation within scope of project delivery. What you'll need:  Bachelor’s Degree in Engineering or Relevant ExperienceRequires strong engineering experience, preferably within a GMP manufacturing environment.Proven project management experience.Strong mechanical capability with hands on experience in a technical role within similar areas.Demonstrated experience in a GDP Compliant environment.Experience in MS Office, MS Project, Change Control & Document Management SystemsProven ability working cross functionally, delivering technical solutions and implementing improvements. If this role is of interest, please apply now!

Project Manager/Project Engineer - Italy, Pescara - 6 Month ContractWith more than 2,000 employees, more than 300 million units per year, and a lot of innovative medicines in the pipeline, no wonder our client is one of the largest production units in the world! Our client produces, packs and distributes in a high-tech environment, sterile injectable medicines. More than 1 million injectable medicines are produced, packaged and distributed every day. Their destination: 170 countries, worldwide!  Do you want to work with an exciting company who are an established market leader within their niche field? We have a fantastic opportunity for a Project Manager/Project Engineer to work on an exciting CapEx project in Italy on an initial 6 month contract. As Project Manager/Project Engineer, you will play a key role in the successful delivery of a new state of the art facility.What you'll do: Can work independently to meet key deliverables and milestones in addition to being able to effectively lead work within a matrix team working under the stewardship of the Site Capital Plan Manager or Senior Project Managers.Works closely with Senior Project Managers to build & manage the Schedule; this includes task forecasting and ensuring controls are in place to anticipate adherence / slippage vs plan and ensure mitigating actions are in place, as required.Establishment and management of routine team meetings to facilitate plan updates, decision-making, problem solving, escalations e.g. resourcing gaps, mitigations vs non-adherence to plan.Provides timely and thorough project update reports to key project stakeholders and senior management.Partners with all other functions responsible for progress of the change project, typically Quality, EHS, Production, Regulatory, External Vendors, among others. What you'll need: Strong knowledge of pharmaceutical manufacturing unit processes; understanding of the Pharma regulatory environment, while not essential, would be advantageous.Minimum of a Degree in a Science or Engineering discipline with extensive project management experience. Project management skills to include experience of successful delivery of projects on schedule and to budget.Fluent in ItalianExcellent written and verbal communication skills. Ability to articulate a problem and communicate effectively. Intuitive and focused on Achieving results.Well-developed interpersonal skills (leadership, integrity, team orientation, flexibility, and creativity).Experience of working remotely within a Project team in a matrixed & virtual environment. If this role is of interest to you, please apply now!#LI-BP1

OEM Automation Lead – Inspection - Ireland, Dublin - 12 Month ContractOur client, a globally recognised pioneer in Biotechnology, are recruiting for the position of OEM Automation Lead – Inspection. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to join them on their global mission to better the lives of those effected by disease and illness. What you'll do: Subject Matter Expert for OEM (Original Equipment Manufacturer)/VPE (Vendor Packaged Equipment) automation on behalf of ClientOverall Technical lead for Syringe Inspection OEM automationWork closely with the Automated Visual Inspection AVI equipment OEM supplier and system integrator and/or internal team in scope and standard of Automation deliverablesOwnership of the inspection area automation including Automation Visual Inspection; Manual Visual Inspection equipment; handling/transfer equipment; robotics; etcIntegrate the Inspection machines and area onto the PCS and MES at SiteUnderstand how the Inspection equipment operates and ensure that all functions are present and testedPrepare and communicate Client requirementsReview and approve Design deliverables (FS, DS, Drawings, Etc)Ensure high standard of configuration and codingPlan, attend and supervise UAT/FAT/SATs What you'll need: Aveva PI; SQL; Werum PAS/XKnowledge of networking and thin client technology:OEM Syringe AVI Machine or similar equipment experience; Korber; Robotics; Manual Inspection Booths.Machine safety directive expertise and experience on safety PLC systems;Pharmaceutical experience Drug Production Fill FinishProven Leadership abilityExcellent interpersonal and communication skillsReference Project experience If this role is of interest, please apply now! #LI-BP1

Automation Engineer - Dublin - 12 month contractDo you want to work with an exciting company who are an established market leader within their niche field? We have a fantastic opportunity for an Automation Engineer to join one of our industry leafing clients in Ireland.Responsibilities: Working as part of an experienced Automation NPI site Project Team.Collaborating with Process SMEs, CQV Leads, and Automation Engineers to understand process requirements.Generating all the key technical inputs into functional design specifications from all stakeholders.Participating in and signing off on key Functional design aspects as required.Implementing the ACP’s (Automation Change Pack) to make the required code changes.Supporting project reviews internally with key stakeholders within Automation and customers as required. Requirements: Degree in Electrical/Electronic or Chemical Engineering, or a related field with substantial experience.Extensive experience as an Automation Engineer within the biotechnology industry in a regulated GMP environment, delivering Emerson DeltaV solutions (S88 model) and/or high-level expertise in PLC and SCADA based systems including integration.Ability to liaise with process engineers to define scope and deliver on specifications with very strong documentation skills and attention to detail.Automation Compliance lifecycle & Change management relevant experienceExperience with process plant commissioning. If this role is of interest to you, please apply now!#LI-BP1