Validation Engineer

Summary: The Validation Specialist is tasked with conducting validation studies for manufacturing, packaging, and cleaning processes in solid dosage pharmaceutical production. The role requires expertise in validation, particularly with chromatography vessels and utilities, and ideally includes experience with vaccines. The specialist will collaborate with various departments to ensure compliance and address any deviations or equipment issues during validation. Key responsibilities include designing validation strategies, executing protocols, and maintaining documentation related to validation processes.

Key Responsibilities:

• 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.
• Collaborate with R&D, Quality, and Project Management teams to determine Process and Cleaning Validation requirements for new products.
• Perform product cleaning evaluation and document cleaning validation acceptance limits for processes.
• Assist with change controls, investigations for process deviations, and corrective actions as needed.
• Maintain and update database related to the status of manufacturing and packaging process validation.
• Coordinate and execute validation protocol activities with effective communication with affected departments while keeping the manager updated.
• Act as a backup and provide support in preparation and execution of IQ/OQ/PQ of manufacturing and packaging equipment, facility, and critical utilities systems.
• Prepare, review, and execute packaging engineering study protocol and generate reports.
• Prepare, review, and execute qualification and temperature mapping studies for warehouse storage areas and special temperature-controlled areas.
• Develop and recommend science-based solutions focusing on continuous improvement and compliance.

Key Skills:

• Validation experience in manufacturing, packaging, and cleaning processes.
• Knowledge of chromatography vessels and utilities.
• Experience with vaccines is preferred.
• Strong analytical skills for data analysis and report preparation.
• Ability to conduct failure analysis and determine root causes.
• Effective communication and collaboration skills across departments.
• Experience with change controls and investigations for process deviations.
• Proficiency in maintaining and updating validation databases.
• Knowledge of IQ/OQ/PQ processes for equipment and utilities.
• Understanding of packaging engineering and temperature mapping studies.
• Commitment to continuous improvement and compliance.

Salary (Rate): £45

City: Frimley

Country: United Kingdom

Working Arrangements: undetermined

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other