Freelance Process Validation Engineer
Project Overview:
Join a high-impact containment upgrade project focused on granulation suites within a solid oral dosage manufacturing facility. This is a key role within a multidisciplinary team, supporting critical validation activities from equipment qualification through to final documentation.
Key Responsibilities:
- Develop and execute IQ, OQ, and PQ protocols in line with GMP and regulatory requirements.
- Support the installation and qualification of upgraded containment equipment within granulation processes.
- Interface with engineering, production, and QA teams to ensure seamless execution of validation deliverables.
- Author and review validation reports, risk assessments, and deviation documentation.
- Drive issue resolution and ensure validation milestones are met according to project timelines.
Required Experience:
- 3+ years' experience in validation engineering within pharmaceutical manufacturing (not laboratory-based).
- Strong understanding of solid oral dosage forms, particularly granulation, blending, and tableting processes.
- Proven ability to write and execute IQ/OQ/PQ documentation.
- Familiarity with containment systems and GMP standards in a manufacturing environment.
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