At a Glance
- Tasks: Lead validation of computer systems and analytical equipment to ensure compliance and support supply chain.
- Company: Join a leading pharmaceutical company focused on quality and innovation.
- Benefits: Competitive salary, career development opportunities, and a dynamic work environment.
- Other info: Collaborative culture with opportunities for mentorship and professional growth.
- Why this job: Make a real impact in the pharmaceutical industry while ensuring quality and compliance.
- Qualifications: Degree in a scientific field or extensive industry experience; 5 years in validation roles required.
Job Purpose: Lead and support the validation and life-cycle maintenance of site computer systems and analytical equipment in line with regulatory requirements.
Responsibilities:
- Co-ordinate and lead the validation and life cycle maintenance of site computer systems and analytical equipment to ensure there is no break in the supply chain, thus supporting site objectives.
- Coordinate, lead, and support compliance activity in preparation for any regulatory audit and in response to current and subsequent legislation affecting computer systems validation, analytical equipment validation, electronic records, and electronic signatures. This involves an approval and advisory role with respect to assessments and follow-up corrective actions.
- Provide necessary support for all levels of corporate, customer, and regulatory audits, including face-to-face interaction with inspectors during internal and external regulatory audits (e.g. MHRA).
- Deliver standardised training materials on Computer Systems and Analytical Equipment validation topics and provide training as required.
- Support standardisation of computer systems and analytical equipment validation processes, ensuring consistency and agility with cost benefits.
- Understand the impact on ways of working relevant to Computer Systems and Analytical Equipment validation through changes in legislation.
- Support the delivery of innovative strategies by coordinating appropriate validation standards without adding significant cost to the business, ensuring continuous improvement and long-term viability.
- Act as Subject Matter Expert (SME) for computer system and analytical equipment regulations.
- Support the development and use of systems within the wider networks and maintain links with Central IT, Quality, Shared Services, and other sites.
About you:
Essential:
- Degree in a relevant scientific/technical discipline (e.g. Chemistry, Biology, Engineering, Computer Science) or extensive industry experience in a comparable field.
- Minimum 5 years’ experience in validation/quality roles within GMP pharmaceutical or closely related industry.
- Strong, demonstrable experience of computerised systems validation, spreadsheet validation, and laboratory equipment qualification.
- Solid working knowledge of GAMP 5, 21 CFR Part 11, and related data integrity expectations, with practical application on site.
- Able to write, review, and challenge validation documents, and explain complex validation concepts clearly to less experienced colleagues.
- Proven ability to work cross-functionally, influence stakeholders, and represent validation during audits/inspections.
Desirable:
- Experience in API manufacturing or primary chemical/pharmaceutical operations.
- Experience leading or significantly contributing to CSV/data integrity programmes at site or network level.
- Prior experience mentoring or training in validation topics.
Validation and Quality Engineer in Irvine employer: Booth Welsh Ltd
Booth Welsh is an exceptional employer, offering a dynamic work environment in the nuclear industry where innovation and safety are paramount. Employees benefit from a strong culture of collaboration, continuous professional development, and the opportunity to work on impactful projects that ensure compliance and integrity in pressure systems. Located in a region known for its commitment to engineering excellence, Booth Welsh provides unique advantages such as access to cutting-edge technology and a supportive network of industry professionals.
We think you need these skills to ace Validation and Quality Engineer in Irvine
Validation and Life-Cycle Maintenance
Regulatory Compliance
Computer Systems Validation
Analytical Equipment Validation
GMP Pharmaceutical Knowledge
GAMP 5
21 CFR Part 11
