Full job description

Validation/ Quality Assurance Specialist, Pharmaceutical

Location: Derby

Salary: £30,000-£34,000 depending on experience (plus company bonus)

Hours: Monday - Friday, days, 35h per week

Russell Taylor is working with a leading pharmaceutical manufacturer (CMO) who are continuing to grow; backed by significant investment, new leadership, and modernised validation systems and processes, the company is expanding its validation team at this time.

The Validation Specialist will play a key role in supporting site validation activities across a range of projects. This is a great opportunity for someone with GMP validation experience looking to build on their existing knowledge within a supportive and expanding team. Candidates with equipment or process validation experience from pharmaceutical or other GMP-regulated manufacturing environments are encouraged to apply.

The role:

Plan and execute validation activities in line with site validation plans and project timelines.

• Author and maintain validation protocols and reports across multiple validation areas such as:

Cleaning validation

Computerised systems validation

Equipment and utilities qualification

Process validation

• Interpret validation data against predefined acceptance criteria and document outcomes appropriately.

• Execute validation activities while minimising disruption to manufacturing operations.

• Collaborate with cross-functional teams to deliver validation programmes and report outcomes.

• Maintain validated status of systems, processes, equipment, utilities and cleaning procedures.

• Support and participate in site validation projects and cross-functional teams.

• Generate and execute protocols and reports for non-routine quality or validation-related projects.

• Review analytical data generated by the QC laboratory as part of validation activities.

• Maintain and report validation-related KPIs to support quality performance monitoring.

• Support regulatory inspections and internal audits, including completion of corrective actions where required.

• Investigate non-conformances, performing root cause analysis and risk assessment.

• Support the ongoing maintenance of the Site Validation Master Plan (VMP).

• Ensure validation procedures, SOPs and work instructions remain compliant and up to date.

• Review validation documentation where required.

• Contribute to knowledge sharing and support colleagues across the validation team.

The Person:

• Will hold a degree (or equivalent) in a STEM-related subject, or have relevant hands-on validation experience within a GMP-regulated manufacturing environment.

• Experience in validation within a cGMP setting, ideally involving process validation, equipment qualification and/or utilities validation. Candidates with exposure to validation activities in pharmaceutical, medical device, or other GMP manufacturing settings are welcome.

• To be clear, this role is focused on manufacturing/site validation rather than analytical method validation within QC.

• Experience working in a quality or regulated environment (cGMP / MHRA / GMP).

• Comfortable reviewing data and using IT systems to document and communicate results effectively.

• Strong interpersonal skills with the ability to work collaboratively across teams; fluent in English (written and verbal).

• Keen to develop validation knowledge further and contribute within a growing team environment.