9 of 9 GAMP Jobs

experience managing technical and validation teams, preferably at Director or Senior Management level - Required 7+ years of strong expertise in GxP regulations, CSV, 21 CFR Part 11, Annex 11, GAMP 5, and data integrity - Required Deep understanding of IT system architecture, cloud solutions, integrations, and cybersecurity in regulated environments - Preferred Strong strategic thinking, decision-making, and leadership skills - Preferred In More ❯

degree + 3-5 years' experience or 8+ years in a GMP environment Strong knowledge of PLCs, HMIs, SCADA, and electrical/software systems Experience with technical troubleshooting, documentation (GAMP/FDA), and team collaboration Willingness to travel occasionally for training Excellent organizational and communication skills Preferred Experience with PID loops, servo/VFDs, Allen-Bradley, Siemens, iFix Skills in More ❯

to enable the development of project plans with key milestones. Ensure that all machinery supplied or modified is safe and in accordance with EC and UK regulations, harmonised standards, GAMP guidance and client standards. Develop the software and control systems for machines during commissioning in a structured and controlled way. Ensure all software and design drawings are up to date More ❯

reviews, and change controls. Computer System Validation (CSV): • Ensure all GxP computerized systems meet CSV requirements and are aligned with global standards (e.g., 21 CFR Part 11, Annex 11, GAMP 5). • Oversee validation lifecycle from planning through retirement, ensuring traceability and compliance. • Provide QA review and approval for CSV deliverables, deviations, and risk-based validation strategies. Regulatory Compliance & Inspection … integrity, CSV, Quality Risk Management (QRM) and biopharmaceutical regulatory requirements. • Deep understanding of lab systems such as LIMS, CDS, ELN, and instrument software validation. • Proficiency with validation frameworks (e.g., GAMP 5), risk management, and audit readiness. • Experience with enterprise systems (e.g., TrackWise, Veeva, SAP), digital platforms, and automation environments (e.g., MES, DeltaV, DCS). • Exceptional communication, cross-functional leadership, and More ❯

support post commissioning as well. Top Must Have's: Strong Process Automation project & commissioning experience with the DeltaV platform in a Pharma/Biotech environment. Familiarity with ISA 88, GAMP, cGAMP Clear understanding of Software Development Life Cycle (SDLC), Agile methodologies, automation C&Q activities. RESPONSIBILITIES Responsible for Software Development in DeltaV platform Conduct and oversee Factory Acceptance Testing (FAT … with the DeltaV platform Experience in a manufacturing setting for Life Science industry Understanding of Process Automation implementation in a Pharma/Biotech environment. Familiarity with ISA 88 and GAMP Demonstrated skill with scripting and test automation. Clear understanding of Software Development Life Cycle (SDLC) and Agile methodologies. Qualifications Bachelor's or Graduate's Degree in engineering, chemical engineering, electrical More ❯

Boden Group are recruiting on behalf of a Worldwide leading Pharma Organisation, for a brand new state of the art manufacturing facility based in Cambridgeshire. The Automation Engineer will serve as a senior member of staff in the setup of More ❯

Boden Group are recruiting on behalf of a Worldwide leading Pharma Organisation, fora brand new state of the art manufacturing facility based in Cambridgeshire. The Automation Engineer will serve as a senior member of staff in the setup of the More ❯

including user/functional requirements, validation plans, protocols, reports, and traceability matrices. Liaising with internal teams and vendors to deliver compliant system implementations aligned to Good Automated Manufacturing Practice (GAMP) and agreed standards. Acting as a key contact for audit and inspection activity, particularly around data integrity and system validation. Participating in disaster recovery testing for critical systems and assisting … pace with regulatory expectations. What You'll Bring A proven background in a similar role within IT, Engineering, Life Sciences, or a related domain. Familiarity with regulatory frameworks including GAMP and other relevant standards. Experience working with both custom and off-the-shelf platforms in regulated (GxP) environments-such as in manufacturing, quality control, or clinical settings. Strong written documentation More ❯

including user/functional requirements, validation plans, protocols, reports, and traceability matrices. Liaising with internal teams and vendors to deliver compliant system implementations aligned to Good Automated Manufacturing Practice (GAMP) and agreed standards. Acting as a key contact for audit and inspection activity, particularly around data integrity and system validation. Participating in disaster recovery testing for critical systems and assisting … pace with regulatory expectations. What You'll Bring A proven background in a similar role within IT, Engineering, Life Sciences, or a related domain. Familiarity with regulatory frameworks including GAMP and other relevant standards. Experience working with both custom and off-the-shelf platforms in regulated (GxP) environments-such as in manufacturing, quality control, or clinical settings. Strong written documentation More ❯