and Quality Control Laboratory systems and software used to support the manufacture, packaging, testing, storage and distribution of marketed drug products comply with current GMP and company expectations. Provide input to the review and writing of any associated quality policies, systems and procedures as required and prepare and update SOPs … applications providing independence of access for administrator activities Ensure Qualification and Validation of equipment, processes, systems is/are performed in line with procedures, GMP and GAMP guidelines for process, equipment and electronic systems, as and when required. Ensure the maintenance of procedures supporting Qualification and Validation and review and … of data integrity and application to system management Good understanding of Quality Control Systems and analytical software and electronic Quality Systems Good understanding of GMP Guidelines and Regulations Knowledge of the qualification and validation requirements for equipment and electronic systems Excellent verbal and written communication skills. Apply: It is essential More ❯
and Quality Control Laboratory systems and software used to support the manufacture, packaging, testing, storage and distribution of marketed drug products comply with current GMP and company expectations. Provide input to the review and writing of any associated quality policies, systems and procedures as required and prepare and update SOPs … applications providing independence of access for administrator activities Ensure Qualification and Validation of equipment, processes, systems is/are performed in line with procedures, GMP and GAMP guidelines for process, equipment and electronic systems, as and when required. Ensure the maintenance of procedures supporting Qualification and Validation and review and … of data integrity and application to system management Good understanding of Quality Control Systems and analytical software and electronic Quality Systems Good understanding of GMP Guidelines and Regulations Knowledge of the qualification and validation requirements for equipment and electronic systems Excellent verbal and written communication skills. Apply: It is essential More ❯
week) You will be responsible for: The Data Integrity Analyst Co-Op works alongside Quality Control (QC) laboratory staff learning about GoodManufacturing Practices (GMP) associated with the Pharmaceutical Industry and has responsibility for assisting (or independently performing) various laboratory processes within the QC environment. All tasks performed as part … of this position are completed in compliance with all applicable procedures, standards and GMP regulations. This position may also contribute to improvement projects within the QC organization related to data integrity processes. Key responsibilities include the following: Maintaining a safe work environment in compliance with all applicable environmental, health, and More ❯
and Quality Control Laboratory systems and software used to support the manufacture, packaging, testing, storage and distribution of marketed drug products comply with current GMP and Corporate expectations. Provide input to the review and writing of any associated quality policies, systems and procedures as required. Support the maintenance and administration … independence of access for administrator activities. Ensure Qualification and Validation of EML equipment, processes, systems is/are performed in line with EML procedures, GMP and GAMP guidelines for process, equipment and electronic systems, as and when required. Ensure the maintenance of EML procedures supporting Qualification and Validation ensuring they … Quality Systems. Ability to interpret complex data and present key findings. Ability to describe technical information in easy-to-understand terms. Good understanding of GMP Guidelines and Regulations. Knowledge of the qualification and validation requirements for equipment and electronic systems. Maintain knowledge and understanding of technical advancements in electronic systems. More ❯
Holmes Chapel, Cheshire, United Kingdom Hybrid / WFH Options
Bespak Limited
systems at our Holmes Chapel site. You'll provide hardware and software support, resolve breakdowns, implement preventative maintenance, and ensure compliance with GMP (GoodManufacturingPractice), EHS, and company standards. Your role also involves supporting computer system validation, quality improvement initiatives, and training other team members. This is a hands … and coding support to maintain system performance. Resolve equipment breakdowns and conduct root cause analysis. Support engineering CAPEX and improvement projects. Ensure compliance with GMP, EHS, and company standards. Support computer system validation and lifecycle management. Contribute to engineering best practices and project execution. Train team members on equipment, systems More ❯
Engineering. Proficient in process control systems, including PLC (Rockwell, Siemens), SCADA, Historian, CAD, Trend BMS/Set, Lighthouse EMS, JDEdwards. Experience with GMP (GoodManufacturingPractice). Proactive, methodical, with a 'can-do' attitude. Strong problem-solving skills. Why join Catalent: Competitive salary Pension Holiday entitlement Note: Please refer to More ❯
Comfortable operating autonomously once goals and objectives are set. Excellent interpersonal, written and verbal communication skills. Confidence and ambition to provide pragmatic and considered GMP advice. Having current and up to date professional knowledge, expertise and best practice. Proven ability to engage constructively with colleagues at all levels across different More ❯
To complete customer line forms, questionnaires and specification requests. To set up and maintain data in the companys ERP system(s). To undertake GMP audits according to agreed audit schedule, distribute the results and ensure the closure of actions raised. To lead and/or participate in root cause … methodical, with excellent administrative and strong communication skills. Good relationship building skills with both internal and external stakeholders. An understanding of the principles of GMP and Global Food Safety Initiatives. Personal Skills An excellent multi-tasker, able to manage multiple projects simultaneously and who thrives in a fast paced role More ❯
education and professional registration. In this role you will Specification, Procurement, Installation, Acceptance Testing (e.g. FAT/SAT) of automation systems in a licensed GMP commercial plant Ensure compliance with engineering and EHS standards relevant to the service provided. Engage with external specialist companies engaged to deliver projects or provide … for supporting senior automation engineers in delivery of site automation strategy. Work with site Quality and Validation personnel to ensure automation and control system GMP compliance. Implement and complete change controls, CAPAs, and Deviations for automated GMP systems and equipment. Why you? Basic Qualifications & Skills: We are looking for professionals … P&ID nomenclature Process and Machinery Safety (UKCA/CE, PUWER, HAZOP, SIL) Appreciation of Operational Technology Cyber Security Standards and knowledge of current GMP regulations and an understanding of regulatory agencies expectations and change management in a regulated environment. Closing Date for Applications: 15/5/2025 Please More ❯
/office arrangement as the business requires. The role of the Senior Technical Editor is to manage the creation of new documents and revise GMP documents for complex technical changes. Key responsibilities: Independently manage the creation of new documents and revise GMP documents for complex technical changes according to documented … Tasks and CAPAs Creation and coordination of Change controls and completion of change assessments in Trackwise in conjunction with internal Lonza donors Maintenance of GMP document templates and document style and format standards Advise on document style and content, use of DMS, documentation procedures and documentation best practice and provide More ❯
Specialist to deliver data services to our clients, which include data and benefit audits, preparing data strategies and plans, undertaking various pension rectifications including GMP rectification and equalisation. While we continue to help clients meet their GMP objectives, the data challenges our clients face are becoming more diverse, giving you More ❯
or image analysis. Background or interest in biology, lab automation, or scientific instrumentation. Experience working with or building distributed systems. Experience with regulated environments (GMP, HIPAA, etc.) Experience with UI/product design processes and tools (wireframes, mockups, looks-like prototypes, etc.). Why You'll Love Working Here Impact … of software, hardware, and biology-you'll constantly learn and develop new skills. Autonomy : You'll have the freedom to shape our approach to GMP readiness, with support from a talented cross-disciplinary team. Team : Work with the best engineers and scientists in a collaborative environment where diverse perspectives drive … enjoys moving fast, strives for continuous improvement through learning from mistakes, and is passionate about work that contributes to solving real world problems. No GMP experience? No problem! We want someone who is motivated to deliver an innovative product into a regulated space with creative, efficient solutions. If you're More ❯
Automation Engineer Location: London Our client is a gene therapy company that works with gene therapy discovery, development, and GMP manufacturing. They have headquarters in London and the USA and have recently redesigned exciting new labs with cutting-edge technology and the ability to work to a higher standard and … test plans, and Functional Specifications. Design Specifications, and drawings and diagrams. Work with site Quality and CSV personnel to ensure automation and control system GMP compliance. Raise and complete Quality Events, change controls, CAPAs, and Deviations for automated GMP systems and equipment into the site QMS system. Support training efforts … for new equipment installations. Responsible for ensuring that own work complies with GMP, Data Integrity, and GDP and is undertaken in accordance with applicable procedures. Skills Required: Bachelor's degree in Engineering from an accredited university in mechanical, chemical, or electrical disciplines with minimum 5 years' experience, supporting or developing More ❯
of BigQuery. Be an evangelist to help our clients be at the top of their game by helping with their technical solutions of the GMP & GCP tools. Be an advocate for GA4, and BigQuery to deliver cutting edge solutions Working with a variety of teams across the business to assist … in Google Cloud products notably BigQuery, Firestore and Google Cloud Storage Hands on experience with BigQuery and other Google Cloud tools Experienced throughout the GMP tech stack GMP & GCP Certified Equal Opportunities Equal Opportunities Assembly is an advocate for equal opportunity in the workplace. We are committed to ensuring equal More ❯