Life Sciences Jobs in the USA

CQV Owners Representative - Copenhagen - 12 Month ContractOur client, a global pharmaceutical company, are looking for a CQV Owners Representative 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: Work as Owners rep witnessing CQV contractor, people with enough knowledge to spot when something is wrong and know how to work within a project to get this rectified, ensuring CQV contractor delivers to scope1 Utilities and 1-2 Recovery/Clean Utility focusedEnsure that Commissioning, Qualification, and Validation (CQV) activities meet project and regulatory requirements. What you'll need: Must have experience managing large construction projects (500mn )Client-side experience is preferredStrong experience and proof having worked in a similar role/project. If you would like to apply or find out more, get in touch now!#LI-SC1

HVAC Lead - Denmark, Copenhagen - 12 Months Initial ContractOur client, a global pharmaceutical company, are looking for a HVAC Lead 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: Work alongside the EPCM/V and provide direction on areas that can be exploited. The site is huge and they need to help improve the delivery of the EPCM/VIdentifying opportunities to improve scheduleEnsure EPCM/V progress reporting is accurate and if not ensure this is resolvedEnsuring EPCM/V are allocating enough bodies into right areas to achieve required progress What you'll need: A strong background on previous project work in the Pharmaceutical IndustryRobust personalities who can strongly and confidently manage the EPCM/VStrong HVAC experience. If you would like to apply or find out more, get in touch now!#LI-JS5

Project Manager - Ireland, Arklow - 12 Month Contract Are you local to Arklow and looking for your next contract assignment? Our client, a leading pharmaceutical organisation, are recruiting for a Project Manager to join their newly assembled team and help contribute towards the development of their next core projects.   What you'll do: Build relationships with the site teams, manage the projects, and execute improvement initiatives to drive growthDrive projects to ensure complianceMaintaining working with appropriate stakeholders (QA, Maintenance, Capital) to improve unit efficiency and performanceDevelops a knowledge and understanding of products/systems/services, customers and customer needs of business area supported.Conducts feasibility studies, determines manpower and cost estimates, and develops engineering criteria. What you'll need: Primary Degree in Mechanical / Process / Chemical / Electrical EngineeringExtensive Project Experience with knowledge and exposure to Process Plant, Utilities, Electrical, Maintenance & Facilities systems and ideally within a highly regulated GMP environmentUnderstanding of GMP and the Quality standards required in the Pharmaceutical Manufacturing sectorAPI Previous experience ideally If this role is of interest to you, please apply now!#LI-FY1

Lab CSV Engineer - Dublin, Ireland - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a Lab CSV 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: Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for computer systems and software applications.Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure compliance with regulatory guidelines and internal policies.Perform risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities.Create and maintain validation documentation, such as validation plans, test scripts, traceability matrices, and validation summary reports.Conduct periodic reviews to ensure ongoing compliance with regulatory requirements and internal procedures. What you’ll need: Bachelor's degree in Computer Science, Engineering, or a related field.Experienced in computer systems validation (CSV) from requirements to through release of analytical instruments used in Quality Control (QC) laboratories or in manufacturing operations as part of Process analytical Technology (PAT).Experienced in computer systems validation (CSV) of server / database-based laboratory software, middleware and enterprise applications, for example LIMS, Empower, NuGenesis.Completion of Electronic Record Electronic Signatures (ERES) assessments and Data Integrity Risk Assessments for analytical instruments and software systems.Experienced in the use of paperless validation and test tools such as ValGenesis, Kneat, ALM.  If this role is of interest, please apply now!#LI-JS4

CQV Engineer Benchtop Equipment - Dublin, Ireland - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a Benchtop Equipment CQV 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: Development and execution of CQV testing documentation for benchtop, mobile, analytical, PAT, incubators, BSCs, and TCU equipment 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 are tested in compliance with good manufacturing practices, company policies and EU & FDA regulations.Responsible for ensuring that all equipment, is tested in compliance with project related standards from a commissioning perspective.Deviation management associated with the assigned equipment and utilities. What you’ll need: The ideal candidate should hold a minimum of a BS qualification (Degree) in a scientific, technical or engineering disciplineExtensive experience within the pharmaceutical industrial ideally with familiarity with Sterile Drug Product filling line experience.Demonstratable capacity to effectively execute the CQV testing approach for assigned from initiation to completion.CQV project lifecycle experience from design through to C&Q and handover.Demonstrable experience of performing as part of diverse team of CQV professionals/ contractors to deliver on tasks safely, with quality focus, on time and within budget. If this role is of interest, please apply now!#LI-JS4

CQV Engineer - Formulation & Component Prep - Dublin, Ireland - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a CQV 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: Development and execution of CQV testing documentation for Equipment 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 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 non GMP equipment, are tested in compliance with project related standards from a commissioning perspective.Deviation management associated with the assigned equipment and utilities. What you’ll need: The ideal candidate should hold a minimum of a BS qualification (Degree) in a scientific, technical or engineering disciplineExtensive experience within the pharmaceutical industrial ideally with familiarity with Sterile Drug Product filling line experience.Demonstratable capacity to effectively execute the CQV testing approach for assigned from initiation to completion.CQV project lifecycle experience from design through to C&Q and handover.Demonstrable experience of performing as part of diverse team of CQV professionals/ contractors to deliver on tasks safely, with quality focus, on time and within budget. If this role is of interest, please apply now!#LI-JS4

Construction Manager - Dublin, Ireland - 12 Months Initial ContractOne of the top 10 best companies to work in Ireland is looking for a Construction Manager 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: Lead all construction activities across assigned capital and expense projects, ensuring safe, compliant, and efficient execution.Manage construction methodologies, site logistics, contractor mobilisation, and sequencing of works.Ensure construction execution aligns with project scope, design intent, and regulatory requirements.Maintain accountability for construction safety performance in line with Irish legislation, company corporate standards, and Good Engineering Practices (GEP).Implement Construction Stage Safety and Health Plans under Irish Construction Regulations. What you’ll need: Degree in Construction Management, Civil/Structural/Mechanical Engineering, or a related discipline.Extensive experience as a Construction Manager or Senior Engineer within pharma, biotech, or advanced manufacturing sectors in Ireland.Understanding of Environmental Health & Safety requirements including permit to work, method statements, risk assessments, incident reporting.Demonstrated success delivering complex projects in live operational environments.Strong understanding of Irish construction regulations, permitting, PSDP/PSCS roles, and safety legislation. If this role is of interest, please apply now!#LI-CB1

Cleaning Validation Engineer - Dublin, Ireland - 12 Months Initial ContractOne of the top 10 best companies to work in Ireland is looking for a cleaning validation 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: Performing all aspects of cleaning sampling required for cleaning validation for a new product.Activities include swab and rinse sampling, sample preparation, LIMS administration, submission to QC for analysis, correlation of QC results with cleaning change over protocols/ cleaning logbooks.Supporting product changeover activities.Assisting with LOTO (lockout/ Tagout) activities where required.Generation of standardized cleaning validation ECPs (Energy Control Plans). What you’ll need: A minimum of a BS qualification (Degree) in a scientific, technical or engineering discipline.Previous cleaning validation experience is an advantage.The ideal candidate would have biopharmaceutical Process / Validation knowledge.Exposure to cGMP in a fast-paced environment is required.Previous experience in working in a drug product filling facility would be advantageous. If this role is of interest, please apply now!#LI-JS4

Process Validation Specialist - Oxfordshire, UK - 12 Month ContractAre you a Process Validation Specialist professional with experience in Cell & Gene therapy? Are you looking to take the next step in your career and be part of an exciting new project? Then the position of process validation specialist is exactly what you’re looking for. This is your chance to work for a company that is a pioneer in gene and cell therapy focussing on long-term curative treatments. With vast investment being made into the organisation and new build projects on the horizon this is the ideal time to join the team and establish yourself as a key team member. Led by an experienced executive team, this is a fantastic opportunity to work for a high-profile Biopharma client. Essential Duties and Responsibilities for this x role include, but are not limited to, the following: Lead and execute process validation activities for cell and gene therapy manufacturing processes.Develop and author process validation documentationConduct ancillary validation studies (e.g., hold time validation, mixing studies, sterile filter validation).Ensure compliance with regulatory requirements for process validation and PPQ.Collaborate with cross-functional teams to support process characterization and control strategy development. Desirable Experience: Proven track record in process validation and process performance qualification (PPQ) within GMP manufacturing environments.Hands-on experience authoring validation documentation.Familiarity with regulatory requirements for process validation.Experience conducting ancillary validation studies).Prior exposure to cell & gene therapy or biologics preferred; small molecule experience acceptable. #LI-JM1