King Of Prussia, Pennsylvania, United States Hybrid / WFH Options
CSL Behring
stakeholders and drive tool adoption at scale including a strong communication and stakeholder engagement skills. Experience in regulated environments (e.g., life sciences) with knowledge of 21 CFR Part 11, GAMP desired Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and More ❯
and electrical wiring diagrams, communication networks, control panels, HMI, MES, SCADA, PLC and Historians. Broad and in-depth knowledge with practical experience of computer and application validation (preferably using GAMP methodology ), cGMPs , and 21 CFR Part 11 in an FDA regulated environment. Proven experience in lead ing and manag ing teams effectively, with a strong track record of fostering a More ❯
Develop and maintain control systems using PLC, DCS, HMI, and SCADA technologies. Write and review key documentation (URS, SDS, IQ/OQ/PQ, SOPs) and ensure compliance with GAMP and 21 CFR Part 11. Support system lifecycle activities, including change control and system upgrades. Troubleshoot control systems and instrumentation, perform root cause analyses, and recommend improvements. Lead the design More ❯
Develop and maintain control systems using PLC, DCS, HMI, and SCADA technologies. Write and review key documentation (URS, SDS, IQ/OQ/PQ, SOPs) and ensure compliance with GAMP and 21 CFR Part 11. Support system lifecycle activities, including change control and system upgrades. Troubleshoot control systems and instrumentation, perform root cause analyses, and recommend improvements. Lead the design More ❯
working with diverse engineering teams and third-party contractors Strong financial acumen: experience managing cash flow, life-cycle costs, and project finances Knowledge of 21 CFR Part 11 and GAMP is a plus Automation, robotics, or pharmaceutical industry experience is advantageous Ambitious, confident, and professional: strong planning, communication, and organisational skills Full, clean driver's licence (required for site visits More ❯
knowledge of cGMPs: 21 CFR Parts 11, 210, 211; EU Directives 75/319/EEC, 2003/94/EC; Annex 11, and related GMP guidelines. Proficiency with GAMP guidelines (particularly GAMP 5): risk-based validation approaches for GxP systems. Experience in software development, testing, and validation processes. Strong quality audit and software quality metrics expertise. Bachelor's degree More ❯
Chalfont St. Giles, Buckinghamshire, South East, United Kingdom
TREVETT PROFESSIONAL SERVICES LTD
Automation Engineer R&D North London £70,000 + Benefits Trevett Services is currently working with a client direct who are seeking the appointment of Automation Engineers on their new research and development site based in the North London area. More ❯
Cambridge, Cambridgeshire, East Anglia, United Kingdom
Oxford Gene Technology Ip Ltd
protocols (IQ, OQ, PQ), summary reports, and traceability matrices. Create and maintain documentation in accordance with company standards, regulatory guidelines, and industry best practices. Such as FDA 21 and GAMP 5. Ensure that all documentation is clear, concise, accurate, and easily understood by the target audience. Develop, write and revise work instructions and SOPs. Collaboration and Support: Work closely with More ❯
protocols (IQ, OQ, PQ), summary reports, and traceability matrices. Create and maintain documentation in accordance with company standards, regulatory guidelines, and industry best practices. Such as FDA 21 and GAMP 5. Ensure that all documentation is clear, concise, accurate, and easily understood by the target audience. Develop, write and revise work instructions and SOPs. Collaboration and Support: Work closely with More ❯
cross-functional engagement CSV Analyst - Requirements : Minimum of 3 years' experience in SAP validation within regulated (GxP) environments Strong understanding of CSV frameworks and regulatory requirements (GxP, FDA, EMA, GAMP 5) Familiarity with pharmaceutical manufacturing processes and SAP QM (Quality Management) modules Demonstrated expertise in authoring and managing validation documentation across the system lifecycle Experience working in complex stakeholder environments More ❯
and controlled documents. Support the project team as they work towards execution and handover Requirements: 3+ years experience of life sciences experience Knowledge and illustrated experience of working with GAMP, 21 CFR Part11 etc. Excellent ability to work with others showcasing strong communication and organisational skills Prior experience of working in automation projects is preferred More ❯
Liverpool, Merseyside, North West, United Kingdom Hybrid / WFH Options
CRESSIDA CONSULTING LTD
/OQ, cable schedules, I/O lists Electrical panel layouts and schematics using Eplan 8 Collaborating with mechanical, process and EC&I teams Global commissioning, testing and validation (GAMP, FDA, ATEX, SIL) What Youll Bring Degree or HND in Electrical, Automation or similar field Experience in automation and control of complex systems Confident working with Eplan or similar electrical More ❯
implement Siemens automation solutions (PCS7, SIMATIC SCADA, TIA Portal, MES). Program and troubleshoot PLC (S7-1500, S7-1200) and DCS for optimized process control. Ensure compliance with GMP, GAMP, FDA guidelines in automation projects. Oversee commissioning, validation, and maintenance of automation systems. Collaborate with process engineering, IT, and quality teams to enhance automation efficiency. Stay updated on emerging Siemens … Required Technical Skills: 5+ years in pharmaceutical automation with Siemens systems. Strong expertise in PCS7, SCADA, MES, and PLC programming (TIA Portal) . Deep knowledge of regulatory standards (GMP, GAMP, FDA) . Experience managing automation projects, validation, and troubleshooting . More ❯
test plans and test protocols Project delivery reporting Working within a client-led team to deliver a key client project Stakeholder management Experience of working with S88, PCS7 and GAMP 5 Qualifications Candidates must have proven experience of automation delivery on multiple projects in the pharmaceutical industry. Knowledge of industry standards and systems is essential, alongside a good understanding of More ❯
Billingham, Stockton-on-Tees, County Durham, United Kingdom
PM Group
test plans and test protocols Project delivery reporting Working within a client-led team to deliver a key client project Stakeholder management Experience of working with S88, PCS7 and GAMP 5 Qualifications Candidates must have proven experience of automation delivery on multiple projects in the pharmaceutical industry. Knowledge of industry standards and systems is essential, alongside a good understanding of More ❯