- Generation and execution of validation protocols and reports (including IQs, OQs, PQs, QAPs, etc.).
- Working as a seconded PM Group resource in a client-led team.
- To lead and/or support validation projects and activities on site, as directed and as appropriate.
- To prepare validation plans in line with the strategic goals of the client and to manage timely and compliant delivery of the plan.
- Commissioning and validation of various new technologies and new equipment.
- To develop and execute Commissioning & Qualification lifecycle protocols as per the specific project requirements.
- Leading and supporting SATs.
- Supporting and representing the technical quality team in meetings, visits, troubleshooting exercises, and audits.
- Ensuring manufacturing equipment is qualified in line with production schedule requirements.
- Developing and writing validation procedures according to cGMP and regulatory requirements.
- Generating and executing validation documentation.
- Providing continuous improvement for existing validation procedures.
- Data collation and analysis via sophisticated computer software.
Qualifications & Requirements
Applicants will have experience of equipment validation on multiple projects in the pharmaceutical and/or biopharmaceutical sectors. Successful candidates will be able to demonstrate technical competence, will be able to work efficiently and safely, and will be willing to supervise and train others in any specialist areas of which the candidate is knowledgeable.