Validation and Quality Engineer

Booth Welsh Ltd; Irvine; On-site; GBP 60,000 - 75,000; Full time

Job summary

Booth Welsh Ltd in Irvine, UK, seeks a lead for validation and lifecycle maintenance of site computer systems and analytical equipment to ensure supply chain continuity.

You will coordinate regulatory compliance activities for audits, develop standard validation practices, and act as SME for data integrity and electronic records, collaborating with IT, Quality, and site teams. The role includes delivering training and guiding improvements while staying aligned with GAMP 5 and 21 CFR Part 11.

Qualifications

• Minimum 5 years of experience in validation/quality roles within GMP pharmaceutical or closely related industry.
• Strong experience with computerised systems validation, spreadsheet validation and laboratory equipment qualification.
• Solid working knowledge of data integrity expectations with practical on-site application.
• Able to write, review and challenge validation documents and explain complex concepts clearly.
• Proven ability to work cross-functionally, influence stakeholders and represent validation during audits/inspections.

Responsibilities

• Lead validation and lifecycle maintenance of site computer systems and analytical equipment to avoid supply chain disruption.
• Coordinate compliance activities for regulatory audits and responses to legislation affecting CSV and electronic records.
• Support internal and external audits, including interaction with inspectors (e.g., MHRA).
• Deliver standardised training materials on computer systems and analytical equipment validation and provide training.
• Standardise validation processes to deliver consistency and cost benefits.
• Understand impacts of legislation changes on validation workflows.
• Act as SME for computer systems and analytical equipment regulations.
• Collaborate with Central IT, Quality, Shared Services and other sites.

Skills

CSV validation

GAMP 5 knowledge

Regulatory compliance

Audit readiness

Education

Degree in a relevant scientific/technical discipline

Tools

GAMP 5

21 CFR Part 11

Job description

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 as appropriate to ensure there is no break in the supply chain thus supporting Site objectives.

Coordinate, lead, and support the compliance activity in preparation for any regulatory audit and in response to current and any 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.

To provide the necessary support, as required, 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).

To deliver standardised training materials on Computer Systems and Analytical Equipment validation topics and deliver training as required.

Support standardisation of computer systems and analytical equipment validation processes, supporting roll out and adherence to these standard validation processes to deliver consistency and agility with cost benefits.

To understand the impact on ways of working relevant to Computer Systems and Analytical Equipment validation as required through changes in legislation.

Support the delivery of innovative strategies that are implemented by co-ordinating 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