7 of 7 GAMP Jobs

Cybersecurity, and Infrastructure teams. Desirable Experience TOGAF or equivalent architecture certification. Experience with ISA-95, ISA-88, IEC 62443, Purdue Model, NIST, ISO 27001, GAMP 5, CSA, or similar frameworks. Experience supporting large-scale digital transformation, site expansion, manufacturing modernisation, OT remediation, or paperless manufacturing programmes. Exposure to cloud platforms ...

biotechnology environment. Experience working in CSV for manufacturing automation systems such as DeltaV, PI Historian, PLC, or Lab Automation Systems. Strong knowledge of GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, risk-based validation, and CSA principles. Solid understanding of the Software Development Life Cycle (SDLC), Change ...

Validation (CSV), Computer Software Assurance (CSA), automation compliance, shopfloor, enterprise, laboratory, and quality systems within a regulated pharmaceutical or biotechnology environment. Strong knowledge of GAMP 5, FDA 21 CFR Part 11, and EU GMP Annex 11. Strong knowledge of risk-based validation and CSA principles. Strong knowledge of Software Development ...

least 1.5 years in a leadership role within a pharmaceutical operation. Expertise in the application of 21 CFR Part 11, EudraLex Annex 11 and GAMP standards for data integrity and validation of automated systems is required. Proven experience of managing data integrity initiatives, particularly in relation to computerized systems, within ...

/or globally regulated environments and a good understanding of GxP standards and risk-based validation. Knowledge of FDA guidance and industry standards (e.g., GAMP). Experience writing and executing documentation for all aspects of validation deliverables (e.g., Requirements, Compliance/Validation Plans, Test Protocols, Test Summary Reports, and Compliance ...

mentor less experienced engineers Desirable Experience Chartered Engineer status or working towards CEng Experience within pharmaceutical, medical device or other regulated environments Knowledge of GAMP, GMP and ISO standards Cross-disciplinary knowledge across mechanical, electrical and software engineering Experience leading small projects or engineering teams Why Join? This ...

Hands on experience with DCS systems (ideally Siemens SIMATIC PCS7) Previous work experience in a GMP manufacturing environment (Pharmaceutical experience is desireable) Knowledge of GAMP frameworks Willing to work on customer sites across the Northwest Code: INDENM If you are interested in this position please click 'apply'. Hunter Selection ...