We are seeking a Validation Engineer to join our client's team within the biopharmaceutical sector. In this role, you will play a pivotal part in ensuring that equipment, processes, and systems are fully compliant with regulatory standards. You will work collaboratively with cross-functional teams to validate both new and existing manufacturing platforms, resolve quality issues, and uphold the highest standards of documentation and compliance.
Key Responsibilities
- Lead validation projects for new and modified manufacturing equipment, processes, and utilities (IQ, OQ, PQ protocols).
- Write and review validation documentation: validation plans, protocols, reports, risk assessments, and change controls.
- Collaborate with Quality Assurance, Engineering, and Manufacturing to resolve deviation investigations and CAPAs.
- Perform validation and commissioning activities, including qualification testing and acceptance.
- Support continuous improvement initiatives, focusing on process optimisation and compliance.
- Ensure validation activities meet internal SOPs and external regulatory requirements.
Qualifications
- Degree in a science, engineering or related discipline is essential
- 3+ years in validation engineering within a GMP-regulated biopharmaceutical or pharmaceutical environment.
- Experience working with syringe filling machines and isolators a major advantage
- Demonstrated experience with IQ, OQ, PQ lifecycle for equipment and processes.
- Proficient in producing validation documentation and technical reports.
- Excellent interpersonal, communication, and project management skills.
