The Senior Validation Engineer will oversee validation strategies and documentation related to process, cleaning, filter, and sterilisation/sanitisation activities at Contract Manufacturing Organisations (CMOs). These CMOs cover synthetic, small molecule, and large molecule products manufactured at API, DS, DP, and FDP sites. This role ensures compliance with quality standards while facilitating effective collaboration with CMOs.
Key Responsibilities
- Act as a key quality representative within cross-functional teams, including Operations, Analytical Science, Process Development, and Supply Chain.
- Lead quality efforts for technology transfers, new product introductions, and ongoing validation maintenance activities.
- Translate quality and validation requirements into actionable terms for CMOs.
- Identify and assess validation and quality risks to enable risk-based decision-making.
- Author and approve validation documents, including those for aseptic processing systems (e.g., media fills, autoclave validation, environmental monitoring).
- Prepare materials and playbooks for audits and regulatory inspections.
- Perform validation change control assessments and review/approve validation deviations.
- Review and approve Master Batch Records and other production documentation.
- Conduct on-site support and Person-in-Plant activities as needed.
- Escalate critical validation or quality issues to management.
- Write and review responses to regulatory questions (RTQs).
- Drive operational excellence and implement continuous improvement initiatives.
Authority
- Approve or reject validation documentation and activities.
- Provide strategic input on validation topics and site-wide initiatives.
- Approve Master Batch Records.
Qualifications
- Bachelor's or Master's degree in a relevant field (Engineering, Science, or equivalent).
- Extensive experience with validation activities, including process, cleaning, and aseptic processing systems.
- Strong knowledge of regulatory standards for pharmaceutical manufacturing (e.g., EMA, MHRA).
- Proficient in risk-based validation approaches and troubleshooting complex issues.
- Excellent communication and collaboration skills, with a proven ability to work cross-functionally and with external partners.
- Experience in managing validation activities across multiple CMOs is highly desirable.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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