Charlotte Dennis

QA Validation Engineer - North Carolina, United States - 9-months contractOur client works across regulated sectors to build robust, repeatable compliance and validation practices. They prioritise clear guidance, clean documentation, and controls that fit how teams operate.  What you’ll do: The QA Validation Specialist is responsible for implementing, executing, and assessing quality systems, procedures, and records to support compliant GMP operations.The role works closely with Validation, Engineering, Manufacturing, Quality Control, Facilities, and Automation teams.Provide hands‑on QA support and oversight to internal teams and suppliers/contractors to ensure compliance with applicable quality standards, regulatory requirements, and industry guidance.Review and approve commissioning, qualification, and validation documentation.Review and approve qualification and validation deviations and discrepancies, supporting investigation and corrective actions.Work collaboratively across site functions to instil a strong quality culture, coaching in the application of GMP principles and the rationale behind them.Author, review, and approve controlled documents for Quality and other GMP functions, including SOPs, specifications, protocols, and reports.Assist in the preparation for, and hosting of, regulatory inspections and audits as required. What you’ll need: Degree in biological, physical or chemical sciences, engineering, or a related field, with  experience in QA within biologics manufacturing. Strong knowledge of risk‑based approaches to qualification and validation in a biotech quality environment.Hands‑on experience with qualification and validation of process equipment, isolators, bioreactors, clean utilities, automation systems, sterile filling, and cleanroom facilities.Solid understanding of relevant regulations and guidelines, including US and EU frameworks (e.g. FDA, EMA), ICH guidance, and industry best practice.Proven track record of working in a fast‑paced team environment, meeting deadlines, and prioritising work across multiple projects.Strong analytical and communication skills, sound judgement, and the ability to work effectively with colleagues and stakeholders.Excellent problem‑solving capability, with experience in root‑cause investigation and CAPA determination. If this roles is of interest to you, apply today!

Design Manager - Paris, France - Permanent Contract Our client is seeking an experienced Design Manager to join their expanding Data Centre project team. The ideal candidate will oversee the delivery of all information related to specific data centre projects. This role requires close collaboration with internal and external stakeholders to ensure the implementation of information management and design standards, ensuring successful delivery at each stage. Responsibilities: Prepare and execute Architectural and Engineering Consultant Agreements, clearly defining Scope of Work, Services, and Fees based on the Owner’s Project Requirements (OPR)Lead the procurement process for services, including managing Request for Proposals (RFPs), and evaluate proposals to justify selectionsReview and approve consultant invoices, proactively managing project budgets, and leadingCollaborate with Project and Cost Managers to develop and manage project-specific design work, plans, schedules, and budgetsCollaborate with all project team members and internal stakeholders to ensure all aspects of the design are reviewed and approved as requiredEnsure that the Contractor’s design aligns with local specifics such as climate, workforce standards, and regulatory requirementsReview and manage (end-user driven) design change requests during all stages of designLead cost/time-benefit analyses and present solutions that meet project goalsEnsure full adherence to design standards, documenting any deviations after reaching a consensus with the relevant stakeholder. Requirements: Degree in Design, Architecture, Engineering, or a related fieldExperience leading multi-disciplinary design teams and managing new construction, tenant improvements, and capital improvement projectsStrong understanding of contractual obligations, building regulations, and project delivery frameworks (RIBA)Proficiency in MS Excel, Word, PowerPoint, Outlook, and drafting software (AutoCAD, Revit)PMP or PgMP certification is a plusFamiliarity with building code regulations in countries where our client operates (NL, DE or FR) If this role is of interest to you, please apply now! #LI-ID1

DTI Validation Lead - US, North Carolina - 12 Months Initial ContractOur client, a globally recognized pioneer in Biotechnology, are recruiting for the position of DTI Validation Lead. 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. The project at hand is for the construction of a new build biomanufacturing plant based located on the East Coast. What you'll do: Develop and own the validation strategy for digital technology systems (e.g., MES, DCS/SCADA, Historian, lab systems, asset management tools, and digital workflow platforms).Lead CSV (Computer System Validation) planning and execution.Collaborate with engineering, automation, IT, quality, and construction teams to ensure integration and data flow meet compliance and data integrity standards.Ensure validation deliverables (URS, FS/DS, IQ/OQ/PQ, risk assessments, etc.) are created, reviewed, and approved per project timelines. What you'll need: Extensive experience in CSV/automation/IT validation within pharmaceutical or biotech manufacturing.Experience supporting greenfield/brownfield CAPEX projects highly preferred.Strong knowledge of GAMP 5, Data Integrity principles (ALCOA ), and GMP regulations.Proven leadership in cross-functional environments and vendor/contractor management. If this role is of interest, please apply now. #LI-DA1

Jr. Project Engineer - US, North Carolina - 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 a Jr. Project Engineer to join the team and help deliver this world-class program. What you’ll do: Assist senior engineers in planning, scheduling, and executing project deliverablesPrepare technical documentation, progress reports, and compliance recordsSupport allocation of team resources and track project staffing needsMonitor construction activities and sterile environment requirements to ensure compliance What you’ll need: Extensive relevant experience in engineering or project coordinationPharmaceutical background preferred but not mandatorySteriles experience (manufacturing or cleanroom environments) and/or construction project exposure strongly desiredStrong organizational and communication skills Don’t miss your chance to be part of something extraordinary, apply now and let’s talk!#LI-KS1

Project Controls Lead - 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 a Project Controls Lead to join the team and help deliver this world-class program. What you’ll do: Lead all project controls activities, including cost management, forecasting, schedule alignment, risk inputs, data processing, and progress measurement.Develop and maintain integrated cost–schedule (EVMS) models to ensure alignment between planned progress, actual progress, and spend.Monitor and report schedule variances, ensuring discrepancies between schedule and cost performance are identified early and escalated appropriately.Manage monthly cost reporting cycles, including accruals, trend analysis, variance identification, and “early warning” indicators. What you’ll need: Extensive project controls experience on large or medium CAPEX projects.Deep experience in cost management with strong understanding of schedule interfaces.Strong command of EVMS, progress measurement, rules of credit, and earned value forecasting.Ability to challenge schedule and identify mismatch between schedule and cost data. Don’t miss your chance to be part of something extraordinary, apply now and let’s talk!#LI-AN1

ANC2 Site Safety Lead - US, North Carolina - 12 Months Initial ContractOur client, a globally recognized pioneer in Biotechnology, are recruiting for the position of ANC2 Site Safety Lead. 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. The project at hand is for the construction of a new build biomanufacturing plant based located on the East Coast. What you'll do: Lead and oversee the overall safety program for the construction of a new drug substance manufacturing facility, ensuring compliance with all safety regulations and standards.Collaborate closely with the main contracting firm to ensure safety is a top priority across all phases of the project.Provide cradle-to-grave project management of safety initiatives from design through to operational start-up and handover.Manage safety elements such as permits, Pre-Start Up Safety Reviews (PSSRs), and ensure a build team that adheres to safety protocols and best practices. What you'll need: Proven experience leading safety programs for large-scale construction projects in highly regulated industries, with experience on projects ranging from $300M to $500M.Strong knowledge of safety standards, protocols, and regulations, including OSHA, MSHA, and other relevant safety certifications.Demonstrated expertise in managing safety from the design phase through to operational start-up and handover, with strong experience working on previous contracts.Experience with managing or working alongside the main contracting firm to ensure site safety. If this role is of interest, please apply now. #LI-DA1

Project Manager - Ireland, Dublin - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a Project 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 project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.What you’ll do: Manage the brand’s book of workDrive scenario planning for projects (with a focus on device, packaging & DP)Develop detailed project timelines, resource plans, and chartersCreate and manage project budgets What you’ll need: BA/BS in a life science, engineering or other technical discipline ExperienceA demonstrated track-record of success, accomplishments & delivering resultsExtensive project management experience within the pharmaceutical/biotech industryExperience with Chemistry, Manufacturing & Controls (CMC) and Packaging, Devices and Artwork desirableExperience with Chemistry, Manufacturing & Controls (CMC) and Packaging, Devices and Artwork desirable If this role is of interest, please apply now!#LI-JS5

CQV Downstream - Denmark - 12 Month ContractOur client, a global CDMO in pharmaceutical manufacturing, is recruiting for a CQV Downstream to join their new and exciting large-scale CAPEX investment programme. With a mission to provide process development and cGMP production in cell culture, microbial fermentation, and gene therapies, this is an outstanding opportunity make a genuine contribution to the biopharmaceutical industry. What you’ll do: Support generation of all CQV Downstream Documentation – FAT wraparounds, DQ, RTM, QRA, SAT/IOC and IOQ, including Final Reports.Generate DST Bridging document, ensuring full alignment with Process Science (PS) in relation to supply of CPPs and CQAs.Support CQV review, aligning with Transition Group in relation to review and approval of all Turnover Packages, both Vendor and Contractor Packages within the Process Equipment Support scope.Liaise with CQV SWAT Team in relation to punchlist closure both pre-M/C and during the CQV execution phase for all Process Equipment Support systems. What you’ll need: Downstream Equipment experience for biopharmaceutical manufacturing facilities. Experience with complex projects and working in or around operating facilities.Demonstrated proficiency communicating and collaborating at a variety of levels with customers, vendors, equipment suppliers and operations staff.Proven success working well in a team environment with flexibility to react to changing business needs. If this role is of interest, please apply now!#LI-KT1

CQ Engineer Isolator - Germany, Frankfurt - 18 Month 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 Isolator 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: Lead the development and optimization of Vaporized Hydrogen Peroxide (VPHP) decontamination cycles for Material Transfer Isolators and Sterile Test Isolators, ensuring compliance with aseptic processing standards and regulatory requirements.Conduct smoke studies to assess airflow patterns and contamination control during isolator interventions. Supported Environmental Monitoring Performance Qualification (EMPQ) activities to validate cleanroom and isolator environments.Experienced in the strategic placement, retrieval, and interpretation of Biological Indicators (BIs) during VPHP cycle development to verify sterilization efficacy. What you’ll need: Bachelor’s degree in Engineering, Life Sciences, or related fieldExperience in CQV within pharma or biotechProficiency in writing and executing qualification protocolsFamiliarity with electronic documentation systems and validation lifecycle Don’t miss your chance to be part of something extraordinary, apply now and let’s talk!#LI-CO1