What are the responsibilities and job description for the Validation Engineer position at Katalyst Healthcares & Life Sciences?
Roles & Responsibilities:
- Review, plan, schedule and organize validation projects for new and existing areas, including manufacturing equipment, processes, plant systems, storage facilities and equipment.
- Develop and implement all necessary standard operating procedures for validation of plant processes, equipment installation and operational qualification (IQ/OQ), performance qualification (PQ), requalification and revalidation of critical systems and utilities.
- Design IQ/OQ/PQ and validation campaigns, develop, prepare, and write the protocols for process validation, equipment validation, cleaning validation, IQ/OQ and performance qualification.
- Coordinate validation and IQ/OQ/PQ activities with production, quality control laboratories and outside contractors providing leadership, training, and guidance.
- Review and analyze moderately complex analytical and physical data generated from validation activities. Write validation final reports that present, summarize, and offer conclusions on the validity of the process based on the results of the analysis and obtain necessary approvals on a timely basis.
- Coordinate the facility qualification program by preparing the protocols, monitoring the execution, auditing the results, and assisting production in resolving any identified problems.
- Recommends validation approaches / strategies, priorities, and resources required. Accountable for accuracy and integrity of protocols, reports and documentation generated to meet regulatory authorities, accountable for meeting critical deadlines for complex projects.
- Provides validation support for Technical Transfer from Research and Development and supports the Regulatory Affairs Department for product submissions and regulatory filings.
- Remain current on legislative, regulatory, and technical changes within the industry, and on training requirements within the facility.
- Continually develops expertise and acts as a technical expert for the various validation and production activities.
- Assign equipment asset number to new equipment.
- Performs regular validation and performance qualification audits as necessary to ensure conformity to all regulatory requirements.
- Identifies areas of validation failure or deviations from established process and product standards, providing recommendation to solve identified problems.
- Participates in regulatory audits by government regulatory agencies and audits by customers.
- Conducts Validation reviews as required during the change control process, deviation process and batch record review process.
- Validate batch record calculations sheets as required.
- Help develop and maintain drawings and diagrams for regulatory agencies and in plant use.
- Support the North American Project Manager and other management in equipment selection and facility modifications.
- This includes supporting URS development and assisting in preparing capital equipment expense requests.
- Support the North American EHS Manager and other management in environmental activities as required.
- Perform other duties as assigned.
