as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong documentation skills and attention to detail, with experience in More ❯
as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong documentation skills and attention to detail, with experience in More ❯
as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong documentation skills and attention to detail, with experience in More ❯
as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong documentation skills and attention to detail, with experience in More ❯
as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong documentation skills and attention to detail, with experience in More ❯
as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong documentation skills and attention to detail, with experience in More ❯
as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong documentation skills and attention to detail, with experience in More ❯
as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong documentation skills and attention to detail, with experience in More ❯
as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong documentation skills and attention to detail, with experience in More ❯
as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong documentation skills and attention to detail, with experience in More ❯
as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong documentation skills and attention to detail, with experience in More ❯
of automation systems. Understanding of device networking and communication protocols. Experience in installing and servicing large integrated systems. Experience in automation controllers and process control (PLCs, Microcontrollers, knowledge of GAMP 5 is a plus). Software and Protocols : Experience writing protocols in Evoware and Venus software Experience in the design, programming, start-up, commissioning, and troubleshooting of integrated laboratory equipment 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 ❯
skills of the project team, in partnership with the Project Engineering Manager. Act as the technical support for machine debug and commissioning, machine strip down, shipping and installation Support GAMP 5 documentation and validation activities. Support daily project team huddles, actioning and resolving project and team issues that are highlighted Support project Engineering Gemba meetings to identify and remove barriers More ❯
Broadway, Worcestershire, United Kingdom Hybrid / WFH Options
Anglian Water Group Ltd
Test Strategies and related artefacts such as Policies and Procedures and managing test activities Knowledge and understanding of the software Lifecycle. Application of the V model as exemplified in GAMP 5 Experience of developing and using automated tools for configuration management and software testing, ideally some experience of SharePoint technologies and data manipulation (preferably JSON and XML) Experience of the More ❯
Specialist will support the Quality Assurance department in maintaining compliance of computerised systems and electronic Quality Management Systems (eQMS). This includes contributing to validation activities in alignment with GAMP 5, Annex 11, and other relevant regulations. The role requires an understanding of Computer System Validation (CSV) principles and practical involvement in regulated environments. Essential Functions To maintain and improve … requirements : None Education and Experience Bachelor's or Masters' degree in Life Sciences, Engineering, Computer Science, or related discipline desirable but not essential. Training in Computer System Validation or GAMP 5 preferred. Computer System Validation training desirable. Knowledge, Skills, and Abilities Proven experience working with ETQ, MasterControl, or similar eQMS platforms - configuration, administration, and user training. Strong working knowledge with … user access, and data integrity in Empower Demonstrable success in leading system migrations or large-scale QMS digitalisation projects. Experience in writing and maintaining validation documentation in line with GAMP 5. Good working knowledge of Computer System Validation. Familiar with electronic quality management systems (eQMS). Familiar with environmental monitoring systems. Experience working within a Quality function on computer systems More ❯
across manufacturing, labs, IT, and logistics Implement and maintain data governance and computer system validation (CSV) strategies Ensure compliance with global standards (e.g., 21 CFR Part 11, Annex 11, GAMP 5) Oversee system validation lifecycle, change control, and data integrity assessments. Act as quality SME during audits and regulatory inspections Support integration of digital systems and automation platforms Mentor and … across manufacturing, labs, IT, and logistics Implement and maintain data governance and computer system validation (CSV) strategies Ensure compliance with global standards (e.g., 21 CFR Part 11, Annex 11, GAMP 5) Oversee system validation lifecycle, change control, and data integrity assessments. Act as quality SME during audits and regulatory inspections Support integration of digital systems and automation platforms Mentor and More ❯
on DCS/PLC systems within a pharmaceutical manufacturing site. Develop and implement validation documentation including URS, IQ, OQ, PQ, and validation plans. Ensure compliance with regulatory requirements (e.g. GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11). Perform risk assessments, impact assessments, and deviation investigations. Collaborate with cross-functional teams including automation, quality, and IT departments. … Validation within the pharmaceutical or life sciences sector. Hands-on experience validating DeltaV systems preferred; other DCS or PLC systems will also be considered. In-depth knowledge of GMP, GAMP 5, and regulatory expectations. Proven ability to author, review, and execute validation protocols and reports. Strong problem-solving, documentation, and communication skills. Ability to work independently on-site in a More ❯
specifications, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) protocols, test scripts, and traceability matrices. Stay current with GxP regulations and guidelines, including FDA 21 CFR part 11, GAMP 5, and other relevant standards, to ensure ongoing compliance and readiness for audits. Job Requirements: Proven experience in the qualification and validation of ERP platforms, specifically SAP, within a regulated … and maintaining comprehensive validation and compliance documentation, with a keen attention to detail and accuracy. In-depth knowledge of GxP regulations and guidelines, including FDA 21 CFR part 11, GAMP 5, and the ability to apply these standards to ensure system integrity and regulatory compliance. More ❯