NPI Compliance Specialist

Quality Technican - UK, Newport - 11 Month ContractDo you want to work at a leading global pharmaceutical manufacturer? If so, this is the assignment for you! Our global client with manufacturing facilities in Southern Ireland, is currently investing significantly in their manufacturing programme. This state-of-the-art facility houses high-technology and next-generation processes to produce OTC and Oral Care Products that are distributed throughout the Globe. As such, they are looking for a Quality Technican to join their Newport based project.What you'll do: Perform support tasks related to the processing and analysis of test specimens.Accurately complete assigned duties in a timely manner.Log and scan samples into proprietary applications/databases, update task management systems, perform initial quality controls, and store samples appropriately.Process sample data received from clients and monitor data completeness, providing feedback to the Technical Account Executive.Perform in-house quality measurements and calibration of scientific equipment. What you'll need: Lab work to ISO 17025 standard.Strong pipetting skills and experience.Experience and comfort level working with chemicals in a lab setting.Demonstrates effective communication skills to convey and receive information.Proficient in MS Office Suite and basic computer skills. If this role is of interest to you, please apply now!#LI-TE1

Equipment Project Manager - US, Ohio - 12 Month ContractBe part of a next-generation pharmaceutical project that’s transforming how medicines are made. We’re supporting a major new-build facility in Ohio, a multi-billion-dollar investment designed to push the boundaries of science and engineering. We’re looking for an Equipment Project Manager to join the team and help deliver this world-class program. What you’ll do: Manage the equipment installation lifecycle for ~175 pieces of equipmentMaintain constant field presence to observe installs in real time and actively drive missing prerequisites and interfaces.Track what is required to get each piece of equipment into the building, placed, installed, and prepared for start-up readiness; ensure obstacles are identified early and removed quickly.Lead and manage two direct-report resources supporting this equipment scope (clear tasking, accountability, daily priorities, and consistent follow-through). What you’ll need: Proven experience managing equipment installation delivery on large-scale capital projects, ideally in pharmaceutical, life sciences, chemical, or similarly regulated/complex industrial environments.Strong mechanical/equipment installation knowledge across air handlers, pumps, motors, reactors, and related package equipment; understands what it takes to make equipment operational (utilities, controls, ductwork/pipework tie-ins, vendor requirements, access, testing readiness).Demonstrated ability to be “boots on the ground” and lead from the field while still maintaining disciplined planning, coordination, and reporting.Experience managing construction subcontractors in an active build environment and driving daily execution, productivity, and accountability. Don’t miss your chance to be part of something extraordinary, apply now and let’s talk!#LI-AN1

CQV Engineer (Inspection) - Ireland, Dublin - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a CQV Engineer (Inspection) for their large-scale new facility in Dublin. Is this you? An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.What you’ll do: Development and execution of CQV testing documentation for Inspection Systems including Syringe and Vial Automated Visual Inspection Equipment and Manual Inspection Booths for the Sterile Drug product facility. 100%Responsible for meeting key project deliverables for safety, CQV schedule and quality of project related documentation/electronic records for equipment, utilities assigned.Responsible for ensuring GMP equipment are tested in compliance with good manufacturing practices, company policies and EU & FDA regulations.Responsible for ensuring that all Inspection equipment, is tested in compliance with project related standards from a commissioning perspective. What you’ll need: A minimum of a BS qualification (Degree) in a scientific, technical or engineering discipline.Extensive experience within the pharmaceutical industrial ideally with familiarity with Sterile Drug Product filling line experience.Excellent communication skills and the ability to influence others.Demonstratable experience working in teams in a matrix environment to deliver CQV elements. If this role is of interest, please apply now!#LI-JS4

CQV Engineer - Ireland, Dublin - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a CQV Engineer (Clean Utilities) for their large-scale new facility in Dublin. Is this you? An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.What you’ll do: Development and execution of CQV testing documentation for Clean Utilities for the Sterile Drug product facility.Responsible for meeting key project deliverables for safety, CQV schedule and quality of project related documentation/electronic records for equipment, utilities assigned.Responsible for ensuring GMP equipment and Clean Utilities are tested in compliance with good manufacturing practices, company policies and EU & FDA regulations.Responsible for ensuring that all equipment, Utilities are tested in compliance with project related standards from a commissioning perspective. What you’ll need: A minimum of a BS qualification (Degree) in a scientific, technical or engineering discipline.Extensive experience within the pharmaceutical industrial ideally with familiarity with Sterile Drug Product filling line experience.Excellent communication skills and the ability to influence others.Demonstrable experience working in teams in a matrix environment to deliver CQV elements. If this role is of interest, please apply now!#LI-JS4

Operational Excellence Specialist - Ireland, Sligo - 12 Month ContractLocated on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for an Operational Excellence Specialist to join their state-of-the-art pharmaceutical facility. They have invested $55 billion in research to discover and develop new medicines in the pursuit of scientific breakthroughs and changing people’s lives. They have 50,000 employees around the world and are continuing to grow. What you’ll do: Responsible for executing continuous improvement efforts throughout the company to meet service, quality and cost objectivesSupport excellence in the day-to-day management of the business through implementation and maintenance of daily management tools.Support functional leadership and assigned teams with development of both strategic project portfolios and detailed project plansEstablish/maintain network of change agents and be the focal point for continuous improvement expertise and troubleshooting within all support functions. What you’ll need: Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities.Continually be conscious of your own safety and that of others, always complying with safety notices and barriers.Report any EHS incidents and/or Near Misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in eAchieve;Support a culture of EHS excellence by recognising and submitting opportunities for EHS improvement on eAchieve. If this role is of interest, please apply now!#LI-JS4

NPI Compliance Specialist - Sligo, Ireland - 12 Month ContractLocated on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a NPI Compliance Specialist to join their state-of-the-art pharmaceutical facility. They have invested $55 billion in research to discover and develop new medicines in the pursuit of scientific breakthroughs and changing people’s lives. They have 50,000 employees around the world and are continuing to grow. What you’ll do: To ensure new products are manufactured following applicable regulatory requirements and policies.Responsible for maintaining the effectiveness of the integration of new products into the NPI quality system.NPI Compliance Specialist is responsible for supporting new product transfers to the site from development through to commercialization, liaising closely with local and external cross-functional teams to provide direction on quality concerns and ensure appropriate mitigation to address potential risk.Support vendor evaluation and approval, managing all technical agreements from initiation, review, approval, and storage.Support review and approval of NPI related Analytical Test Method Transfers and/or validation. What you’ll need: A third level qualification in a science, quality or relevant discipline.A minimum of three years experience in a quality role supporting new product introductions.Strong knowledge of regulatory requirements is requiredRegulatory, quality and New product introduction background.Extensive experience gained within an aseptic processing environment, ideally gained within a quality function. If this role is of interest, please apply now!#LI-JS4

Mechanical Project Developer - Norway, Stavanger - 4 Months Initial ContractAre you looking for an opportunity to work with a medical device organisation based in Norway? If yes, then this is the assignment for you!Our client that specialises in producing and developing training products for the healthcare sector are currently seeking the expertise of a Mechanical Project Developer.What you'll do: Design and develop new product solutions to meet international safety and regulatory standards (EU, US, global)Prototype and test using advanced plastics technologiesCollaborate with cross-functional teams to design new productsDocument solutions in PLM and PDM systemsFacilitate design reviews and write technical requirements What you'll need: Bachelor’s or Master’s degree in Mechanical Engineering, Bio-Mechanical EngineeringExtensive experience in product design and developmentExperience with CAD, simulation tools, and prototypingHands-on experience with plastics, injection molding, rapid prototyping, and additive manufacturingFamiliarity with LEAN engineering principles If this role is of interest to you, please apply now! #LI-JM1

CQV SME / Senior CQV Engineer - US, Illinois - 6-12 Month ContractThis innovative organisation is a global leader in the development and manufacturing of high-quality sterile injectable products, offering solutions tailored to meet the needs of both clinical and commercial markets. With a strong focus on cutting-edge technologies, they are actively driving advancements in drug substance manufacturing. What you'll do: Serve as the technical SME for CQV activities related to PFS lines (Pre-filled Syringe) and Process Equipment.Lead and execute commissioning, qualification, and validation deliverables including URS, FAT/SAT, IOQ, PQ, and summary reports.Provide expert troubleshooting and engineering support during equipment startup, qualification, and early operations.Partner closely with engineering, automation, operations, and quality teams to ensure equipment readiness and compliance. What you'll need: Extensive CQV experience in pharmaceutical or biotech manufacturing.Demonstrated SME‑level experience with PFS equipment, isolators, and aseptic filling technologies. (Pre-Filled Syringe Lines)Strong experience participating in or leading FAT/SAT activities with equipment vendors.Proven ability to lead complex CQV activities with minimal oversight. If this role is of interest to you, please apply now! #LI-FY1

CQV Project Manager - US, Illinois - 6-12 Month ContractThis innovative organisation is a global leader in the development and manufacturing of high-quality sterile injectable products, offering solutions tailored to meet the needs of both clinical and commercial markets. With a strong focus on cutting-edge technologies, they are actively driving advancements in drug substance manufacturing.  What you'll do: Lead, plan, and manage all CQV activities for assigned systems and equipment, ensuring compliance with cGMP, FDA, EU, and site quality standards.Develop and execute CQV strategies, schedules, and documentation (URS, FAT/SAT, IOQ, PQ, summary reports).Coordinate cross-functional teams including engineering, operations, quality, automation, and vendors.Provide technical oversight and troubleshooting during commissioning and qualification phases. What you'll need: Extensive CQV experience in pharmaceutical or biotech manufacturing.Demonstrated experience with PFS equipment, aseptic processing, and isolator technology.Strong understanding of cGMP, GAMP 5, ASTM E2500, and regulatory expectations.Proven ability to manage complex projects and cross-functional teams. If this role is of interest to you, please apply now! #LI-FY1