QA Specialist

Supply Chain Business Analyst - Edinburgh, UK - 12 month initial contractOur client, a global Contract Development and Manufacturing Organisation, specialising in cell and gene therapies, are seeking at Supply Chain Business Analyst. The client is a leader in iPSC and advanced therapy platforms, supporting partners from early development through clinical and commercial production. With facilities in the UK and US, the client combines cutting‑edge science, rigorous quality, and a collaborative approach to accelerate life‑changing therapies to patients.What you'll do: Support focused business processes improvements and digital transformation to maximise system utilisation and process efficiency.Ensure all business change activities are undertaken in a planned, controlled and sensitive manner.Deliver efficiency and quality benefits to the business.Effective Business Change Management including associated documentation changes and resource training.Development and tracking of KPI’s and other associated metrics to demonstrate both quality and business benefits. What you'll need: Formal methods of process documentation including TOM & Use Cases.Process analysis and development of detailed process flows in a complex GMP manufacturing environment.Experienced in a broad range of Supply Chain and ERP related processes (Purchase to Pay, Inspect to Release, Plan to Produce, and including “outliers” in a GMP environment.Excellent project management skills.An understanding of the Software and System Lifecycles including Waterfall, V-Model and Agile. If you would like to apply or find out more, get in touch now!#LI-LH1

Senior Construction Manager - Copenhagen, Denmark - 12 months initial contractOur client, a global pharmaceutical company, are looking for a Senior Construction Manager to join their team. The company has grown to become a world leader in the development, manufacture, and marketing of innovative pharmaceutical products to alleviate some of the world’s biggest health problems. What you'll do: Provide leadership, governance, and oversight as Senior Construction Manager on the client side for a large scale (circa €1bn) package within a larger overall capital program.Drive EPCM performance, ensure safe, compliant delivery.Establish and run client-side governance (stage gates, steering committees, monthly/quarterly reviews).Own KPIs/dashboards (cost, schedule, quality, HSE-leading indicators, change volume, claims status, readiness).Engage executive stakeholders (VPs/Project Directors, Finance, Ops, QA/Validation, EHS) to secure timely decisions on scope changes, resequencing, claims, and critical risks. What you'll need: Previous experience of managing large construction projects (500mn )Client side and engagement with senior level stakeholdersProven ownership of large single construction packagesAccountability across budgets, schedules, quality, safety, contract administrationRisk mitigation If you would like to apply or find out more, get in touch now!#LI-HS1

Assembly Process Engineer - North Carolina - 12-month contractJoin a landmark project as QCS partner with our client a global biologics organization to drive delivery of a cutting-edge facility in North Carolina. Be part of a large-scale investment and play a pivotal role in bringing this world-class program to life.What you'll do:  Act as system owner for device assembly lines (e.g., auto‑injectors), defining assembly steps, tolerances, and in‑process controls for high‑speed operations.Plan and execute FAT/SAT covering feeding, joining, torque/force checks, and vision systems; confirm line balance and error‑proofing.Oversee installation/start‑up and integration with packaging/labeling modules; troubleshoot mechanical and control issues to meet yield and availability targets.Lead qualification and documentation (protocols, deviations, turnover packages), sustaining GMP compliance through ramp‑up. What you'll need:  Previous experience serving as an Owner’s Representative.Extensive experience in medical device assembly engineeringProven delivery of FAT/SAT, commissioning, and qualification with robust in‑process controls (vision, torque/force, error‑proofing) under GMP.Vendor and cross‑functional coordination skills; full‑time on‑site presence in North Carolina. If this role is of interest, apply today! #LI-KC2

Inspection Process Engineer - North Carolina - 12-month contract Join a landmark project as QCS partner with our client a global biologics organization to drive delivery of a cutting-edge facility in North Carolina. Be part of a large-scale investment and play a pivotal role in bringing this world-class program to life.What you'll do:  Own automated visual inspection systems for parenteral products, assuring detection capability, camera/lighting configurations, and data integrity meet quality targets.Lead FAT/SAT planning and execution, including defect kits, sensitivity studies, and false‑reject optimization.Coordinate installation/start‑up and connectivity with upstream/downstream equipment and MES/serialization where applicable.Maintain validation documentation, change control, and performance monitoring to sustain compliant release. What you'll need:  Previous experience serving as an Owner’s Representative.Extensive experience with automated inspection technology and quality systems for sterile injectables.Demonstrated FAT/SAT, commissioning, and qualification in GMP environments, including defect library management and data integrity controls.Cross‑functional coordination and documentation excellence; full‑time on‑site presence in North Carolina. If this role is of interest, apply today! #LI-KC2

Formuation Process Engineer - North Carolina - 12-month contractJoin a landmark project as QCS partner with our client a global biologics organization to drive delivery of a cutting-edge facility in North Carolina. Be part of a large-scale investment and play a pivotal role in bringing this world-class program to life.What you’ll do: Own buffer preparation and compounding systems, translating process needs into equipment specifications and reviewing vendor drawings for cleanability, operability, and fit.Prepare and execute FAT/SAT and commissioning plans for vessels, transfer lines, and CIP/SIP interfaces; confirm materials of construction and sanitary design standards.Orchestrate site installation and start‑up with utilities, construction, and automation; verify recipes, sequences, and alarm philosophies support reliable operation.Lead qualification documentation and change control, ensuring traceability from design decisions to validated performance. What you’ll need: Previous experience serving as an Owner’s Representative.Extensive experience in process engineering with direct experience in buffer prep/compounding, sanitary design, and CIP/SIP.Proven ability to develop and execute FAT/SAT, commissioning, and qualification under GMP with robust recipe/phase logic.Strong stakeholder coordination and documentation discipline; full‑time on‑site presence in North Carolina. If this role is of interest, apply today!#LI-KC2

Filling Process Engineer - North Carolina - 12-month contractJoin a landmark project as QCS partner with our client a global biologics organization to drive delivery of a cutting-edge facility in North Carolina. Be part of a large-scale investment and play a pivotal role in bringing this world-class program to life.What you'll do:  Serve as system owner for syringe filling lines, driving design compliance, ergonomics, and throughput targets across machine centers and infeed/outfeed modules.Develop and run FAT/SAT protocols covering dosing accuracy, reject handling, and environmental controls; validate recipe/phase logic with automation.Manage installation, start‑up, and troubleshooting, coordinating vendors and plant teams to achieve stable, compliant operation.Prepare qualification packages and acceptance reports; resolve deviations and finalize turnover to operations. What you'll need:  Previous experience serving as an Owner’s Representative.Extensive experience in aseptic fill/finish engineering with hands‑on syringe or vial filling equipment and environmental control strategies.Track record delivering FAT/SAT, commissioning, and qualification under GMP, including recipe/phase verification.Strong problem‑solving, vendor management, and documentation skills; full‑time on‑site presence in North Carolina. If this role is of interest, apply today! #LI-KC2

Production Support Process Engineer - North Carolina - 12-month contractJoin a landmark project as QCS partner with our client a global biologics organization to drive delivery of a cutting-edge facility in North Carolina. Be part of a large-scale investment and play a pivotal role in bringing this world-class program to life.What you’ll do: Act as system owner for sterilization and cleaning assets (autoclaves, washers, stopper processing, clean equipment), steering vendor activities from design reviews through site installation and start‑up.Lead acceptance testing plans (FAT/SAT), define critical setpoints and verification checks; confirm equipment receipt, configuration, and readiness for qualification.Coordinate field integration with construction and automation teams so utilities, interlocks, and data capture align with manufacturing needs.Drive issue resolution and documentation (deviations, turnover packages), maintaining GMP‑compliant records through qualification and handover. What you’ll need: Previous experience serving as an Owner’s Representative.Extensive years in pharmaceutical/biotech process engineering with hands‑on exposure to sterilization and cleaning systems (autoclaves, washers, stopper prep).Demonstrated delivery of equipment through FAT/SAT, commissioning, and qualification under GMP.Strong cross‑functional coordination (construction, automation, validation) and excellent technical documentation skills; full‑time on‑site presence in North Carolina. If this role is of interest, apply today! #LI-KC2

Packaging Process Engineer - North Carolina - 12-month contractJoin a landmark project as QCS partner with our client a global biologics organization to drive delivery of a cutting-edge facility in North Carolina. Be part of a large-scale investment and play a pivotal role in bringing this world-class program to life.What you'll do:  Own secondary packaging lines (cartoning, labeling, serialization, case packing), ensuring design and documentation support compliant, traceable packaging flow.Develop FAT/SAT protocols and execute acceptance testing for coding/serialization, label reconciliation, and tamper‑evidence features.Coordinate installation/start‑up with warehouse/logistics interfaces and IT/serialization systems; stabilize line performance and resolve issues.Complete qualification records and change control; hand over a fully documented, validated packaging capability. What you'll need:  Previous experience serving as an Owner’s Representative.Extensive experience in packaging engineering for pharmaceuticals or medical devices, including serialization and label reconciliation.Demonstrated success delivering FAT/SAT, commissioning, and qualification under GMP with strong documentation standards.Effective cross‑functional coordination (quality, IT/serialization, logistics); full‑time on‑site presence in North Carolina. If this role is of interest, please apply today! #LI-KC2

Lead Delta V Engineer - Ireland - 12-month contract Do you want to work for of one of the top 10 best companies to work for in Ireland? If so, this could be your chance! One of our global pharmaceutical clients is looking for a Lead Delta V Engineer to join their team in their new multifunctional facility.What you'll do:  Provide technical leadership, guiding sub-teams and implementing proof of concepts.Consult on all aspects of DeltaV and support operational automation teams with lifecycle management challenges.Collaborate with business units, IT technical staff, and engineering groups to optimize operational efficiency.Work closely with suppliers, Emerson, and solution partners to maintain a cohesive technology roadmap.Focus on DeltaV systems used in biological/sterile, chemical, and pharmaceutical manufacturing environments.Apply expertise across technologies including DCS, SCADA, MES, process data management and analytics systems, and IT integration services.Stay informed on emerging technologies and recommend improvements aligned with business needs. What you'll need:  Bachelor’s degree in Engineering or Computer Science (preferred).Extensive experience in manufacturing or related fields.Hands-on experience with DeltaV process automation systems, including configuration, architecture, and lifecycle management.Familiarity with PLC/SCADA automation systems.Experience in pharmaceutical, biological, or bulk manufacturing environments.Strong understanding of System Development Life Cycle (SDLC), computer validation concepts. General knowledge of IT infrastructure (networking, virtualization, storage) and related technologies. If this role interests you, apply today! #LI-WS1