Position Summary: The Validation Specialist is responsible for performing manufacturing, packaging, and cleaning validation studies for solid dosage pharmaceutical manufacturing and packaging. Must have validation experience of: Chromatography Vessels Equipment Utilities and preferably Vaccines Responsibilities: Responsibilities include, but are not limited to: Design and develop validation strategy for manufacturing, packaging, and cleaning validation. Prepare, review and execute Process Validation protocol for the Manufacturing and Packaging process. Prepare final report packages by analyzing results and preparing summaries of the data to support test and protocol requirements. Work with other departments regarding deviations, out of tolerance conditions and equipment issues observed during validation by conducting failure analysis, determining the root cause, and taking corrective actions. Work with the R&D, Quality and Project Management team to determine Process and Cleaning Validation requirement for the New Products introduced to CPC. Perform product cleaning evaluation and document cleaning validation acceptance limits for process. Assist with change controls, investigations for process deviations and corrective actions as needed. Maintain and keep up to date database related to status of the manufacturing and packaging process validation. Coordinate and execute validation protocol activities with consistent and effective communication with affected departments working autonomously while keeping the manager updated regularly. Act as a backup and provide support in preparation, execution of IQ/OQ/PQ of manufacturing and packaging equipments, facility and critical utilities system. Prepare, review, and execute packaging engineering study protocol and generate report. Prepare, review, and execute qualification and temperature mapping studies for warehouse storage area and special temperature-controlled areas. Develop and recommend science-based solutions with a focus on continuous improvement and compliance.
Back to searchValidation Engineer
Morson Talent
Posted 15 hours ago, valid for a month
Camberley, Surrey GU16 8AB
Full Time
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Sonic Summary
- The Validation Specialist is tasked with conducting manufacturing, packaging, and cleaning validation studies for solid dosage pharmaceutical production.
- Candidates should possess validation experience with Chromatography Vessels, Equipment, Utilities, and preferably Vaccines.
- The role requires a minimum of 3 years of relevant experience and offers a salary of approximately $80,000 to $95,000 per year.
- Key responsibilities include designing validation strategies, preparing and executing validation protocols, and analyzing results to support compliance requirements.
- The specialist will also coordinate validation activities across departments and assist with change controls and investigations related to process deviations.
