Senior CQV Engineer

Drug Product Engineer (Formulation) - Ireland, Dublin - 11 Months Initial ContractDo you want to be involved with exciting pharmaceutical projects? When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a Drug Product Engineer. What you'll do: Provide technical and compliance review and/or authorship of testing protocols, reports, and applicable manufacturing SOPs.Generate and execute documentation for cGMP activities including risk assessments /reports. Management of Equipment Vendors including execution of on-site maintenance visits, management of continuous improvement projects & spare parts criticality assessments.Support/lead maintenance of the validated state of the equipment through execution of revalidation protocols as per Site VMP. What you'll need: Extensive cGMP industrial / engineering experience, Experience in executing on the floor activities such as FAT, SAT, IQ/OQ Specific experience with Autoclave, Parts Washers, and CIP/SIP equipment. Knowledge of Formulation processes. If this role is of interest to you, please apply now!#LI-CH3

Utilities Engineer - Ireland, Dublin - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a Utilities Engineer 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: Support the Critical Utilities Operations and Maintenance team in the day-to-day operation and maintenance of utility equipment.Assist in developing and updating plant operation procedures, maintenance plans, and risk assessments.Help ensure maintenance standards are met to support safe and reliable operations.Review vendor documents and reports, and assist with closing out Work Orders in the site CMMS. What you’ll need: Bachelor’s Degree (Level 8) in a relevant Science or Engineering discipline.Extensive experience providing technical support on an operating site; experience in biopharmaceutical manufacturing is an advantage.Basic knowledge of utility system design, installation, maintenance, and troubleshooting, with the ability to interpret technical documents and process drawings.Basic Knowledge of Good Manufacturing Practices, maintenance systems, and industry regulations related to pharmaceutical manufacturing is desirable. If this role is of interest, please apply now!#LI-JS4

Senior CQV Engineer - Ireland, Dublin - 12 Month ContractOur client is a global leader in pharmaceutical innovation, specializing in the development and manufacture of cutting-edge drugs. As they continue to grow, they’re seeking an experienced Senior CQV Engineer to join their dynamic team and drive forward groundbreaking projects in Dublin. What you’ll do: Ensure Commissioning readiness of Utility Systems to support Equipment Start-up and IOQ Testing, acting as CQV SME on Utility systems.Lead CQV interface with KNEAT.Liaise with all Project Groups to ensure all Systems are managed appropriately for the Project Lifecycle.Support CQV Document Generation. What you’ll need: Extensive experience including experience with design and construction projects for pharmaceutical manufacturing facilities.Experience within Black Utilities.Experience utilising electronic validation systems including KNEAT. Apply today and be part of shaping the future of medicine!#LI-TE1

Validation Engineer - Ireland, Dublin - 11 Months Initial ContractDo you want to be involved with exciting pharmaceutical projects? When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a Validation Engineer . What you'll do: Support the site validation activities across a number of workstreams.Develop and maintain the site Validation Master Plan.Drive development of site EMPQ strategy and implement/maintain EM protocols and procedures for graded pharmaceutical areas, ensuring compliance with regulatory guidelines.Support equipment qualification post Operational Qualification (OQ) through to Process Performance Qualification (PPQ) and subsequent revalidation.  What you'll need: Extensive direct experience with a pharmaceutical or biotechnology company with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.Bachelor’s degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry etc.Prior experience in Cleaning Validation, Temperature Mapping activities, and qualification of Parts Washers and/or Autoclaves.Experience with upstream cell culture and/or downstream formulation/fill finish processes. If this role is of interest to you, please apply now!#LI-CH3

RWE Scientist - United Kingdom - 6 Month ContractOur client is a global biopharmaceutical company manufacturing plasma-derived, and recombination therapeutic products, who in turn deliver high-quality medicines that treat people with rare and serious diseases, and we are now searching on an exclusive basis with the client to appoint a Real World Evidence Scientist to join their busy and rewarding team on a contractual basis for a period of 6 months.What you'll do: Lead the design, execution, and analysis of real-world and observational research studies, ensuring methodological rigor and fit-for-purpose designsManage in-flight Phase IV and post-approval epidemiologic studies; oversee vendors/CROs to ensure quality and timely deliveryConduct and oversee retrospective analyses using large real-world data sources (e.g., claims, EHRs, registries)Contribute to the development of RWE plans and lead feasibility assessments with a focus on Europe (NITAG/regulatory awareness beneficial) What you'll need: Advanced degree (MD, PhD, or MS) in Epidemiology, Biostatistics, Public Health, or a closely related fieldProgressive epidemiology or real-world evidence experienceExtensive experience within Pharma or BiotechAbility to work independently and assume ownership of ongoing work with minimal ramp-up If this role is of interest, please apply now!#LI-KT1

Head of Compliance and Onboarding – Berkhamsted, Hertfordshire– Excellent Benefits We have an amazing opportunity for a Head of Compliance and Onboarding to join our team in our UK office! At QCS Staffing, we’ve been delivering expert talent solutions in five of the world’s fasted growing sectors, and sourcing candidates from all over the globe for over 33 years!  With over 150 employees across our offices in the UK, US, and Europe, we are constantly on the hunt for eager individuals to join our team.What we provide: An inclusive ‘one team’ ethos, with endless socials, charity events and celebrations!Fantastic career progression opportunities, award-winning training and development programs (we invest in YOU)Private Healthcare & Pension planEarly finish on a FridayHybrid workingEnhanced maternity and paternity pay Paid parking   What you'll do: Team Management & Development: Lead a team, helping and supporting with their day-to-day roles, set up & responsibilities, mentoring and supporting their growth and developmentRoute to Market Compliance: Responsible for developing and maintaining the commercial route-to-market frameworks as well as responding to legal and technical route-to-market decisionsCandidate Queries and Onboarding: Issue contracts and manager candidate communications throughout the onboarding process and respond to general candidate queries.Client role & profile setupClient Statements of work & Purchase OrdersCandidate Compliance ChecksProfessional ReferencesIssuing Candidate Contracts What you'll need: Ideally have previous experience in onboarding contractors in the UK, USA and 1-3 European jurisdictions.Experience of using a technology-based on-boarding system and proficient in use of Bullhorn.Ability to review contractor contracts from a legal perspectiveStrong commercial acumen and a pragmatic approach to legal problem-solving.Knowledge of legislation impacting the recruitment sector such as IR35; labour leasing; cross border working; worker’s misclassification; A1 certificates etcProven experience of managing a team of at least 3 peopleAbility to work independently, manage multiple priorities in a fast-paced environment and thrive in a constantly evolving landscape.The candidate must have the rights to work in the location stated in the job advert. If you're driven, curious, and love working with incredible people - apply now and grow with us!#LI-JP1

CQ Engineer PMO - Germany - 18 Month Contract Looking to take your career to the next level? We’re recruiting for a high-impact pharmaceutical project located near Germany. With major capital investment experience driving various facility build projects. This is a unique opportunity for a CQ Engineer PMO to join a global leader in the life sciences market and play a key role in shaping the future of advanced manufacturing. What you’ll do: Support C&Q activities while acting as the team’s PMO specialistOwn and maintain these systems end-to-end, ensuring accuracy, usability, and scalabilityCollaborate with cross-functional teams to ensure project transparency and timely deliveryProvide technical guidance and training to team members on PMO tools What you’ll need: Proven expertise in Microsoft Excel, MS Project, Tableau, and SmartsheetStrong understanding of project lifecycle within pharmaceutical or GMP-regulated environmentsExperience in commissioning and qualification of pharmaceutical equipment or facilitiesAbility to work independently and proactively in a fast-paced project environment Don’t miss your chance to be part of something extraordinary, apply now and let’s talk!#LI-CO1

CQ Engineer - Germany, Frankfurt - 8-9 Months Initial ContractLooking to take your career to the next level? We’re recruiting for a high-impact pharmaceutical project located near Frankfurt. With major capital investment experience driving various facility build projects. This is a unique opportunity for a CQ Engineer to join a global leader in the life sciences market and play a key role in shaping the future of advanced manufacturing. What you’ll do: Execute FAT protocols for Syntegon liquid/aseptic filling lines and autoclave sterilizers.Review and approve vendor FAT protocols, test scripts, and acceptance criteria.Execute mechanical, automation, and functional testing—including safety, alarms, interlocks, and recipe functionality.Document deviations, non-conformances, and corrective actions; ensure timely resolution prior to equipment shipment. What you’ll need: Previous FAT execution experience, strong preference for Filling equipment however the Manager is open to reviewing strong EngineersExtensive hands on CQ experienceP&ID redline and punch list experienceKnowledge and experience with KNEAT Don’t miss your chance to be part of something extraordinary, apply now and let’s talk!#LI-CO1

QC Analyst Microbiology - Ireland, Dublin - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a QC Analyst Microbiology 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: Performe Sterility testing on Drug Product samplesPerforme Bacterial Endotoxin Testing on Drug Product, Drug Substance, Raw Material and Utility samples within required hold times.Performe Bioburden testing on Drug Substance, Raw Materials and Utility samples within required hold times. Performe Growth Promotion testing of media lots entering the laboratory. What you’ll need: The ideal candidate should hold a minimum of a Level 8 degree in Microbiology or related discipline.Extensive experience in a pharmaceutical / healthcare laboratory or related technical function.A strong background in Microbiology and aseptic manufacturing is desirable but not essential.The successful candidate must demonstrate excellent written and verbal communication skills. If this role is of interest, please apply now!#LI-JS4