Validation Engineer

Summary: The Validation Specialist plays a crucial role in ensuring the integrity of manufacturing, packaging, and cleaning processes within solid dosage pharmaceutical production. This position requires expertise in validation studies, particularly for chromatography vessels and utilities, with a focus on compliance and continuous improvement. The specialist will collaborate with various departments to address deviations and implement corrective actions while maintaining thorough documentation and communication.

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 summarizing data to support test and protocol requirements.
• Collaborate with other departments regarding deviations, out of tolerance conditions, and equipment issues, conducting failure analysis and determining root causes.
• Work with R&D, Quality, and Project Management teams to determine Process and Cleaning Validation requirements for new products.
• Perform product cleaning evaluations and document cleaning validation acceptance limits.
• Assist with change controls, investigations for process deviations, and corrective actions as needed.
• Maintain and update the database related to the status of manufacturing and packaging process validation.
• Coordinate and execute validation protocol activities with effective communication across departments.
• Act as a backup and provide support in the preparation and execution of IQ/OQ/PQ of manufacturing and packaging equipment.
• Prepare, review, and execute packaging engineering study protocols and generate reports.
• Prepare, review, and execute qualification and temperature mapping studies for warehouse storage areas.
• Develop and recommend science-based solutions focusing on continuous improvement and compliance.

Key Skills:

• Validation experience in pharmaceutical manufacturing and packaging.
• Knowledge of chromatography vessels and utilities.
• Experience with Process Validation protocols.
• Strong analytical skills for data analysis and report preparation.
• Ability to conduct failure analysis and determine root causes.
• Collaboration skills to work with R&D, Quality, and Project Management teams.
• Proficiency in maintaining databases related to validation processes.
• Effective communication skills for coordinating with various departments.
• Experience in executing IQ/OQ/PQ protocols.
• Understanding of packaging engineering studies and temperature mapping.
• Focus on continuous improvement and compliance in validation processes.

Salary (Rate): £45

City: Frimley

Country: United Kingdom

Working Arrangements: undetermined

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other