What are the responsibilities and job description for the Validation Engineer position at Katalyst HealthCares & Life Sciences?
Responsibilities
- Develop and implement comprehensive validation plans for packaging lines, labelers, case packers, and low-speed pen assembly.
- Lead the validation of various systems, including SEA Vision Yudoo and AVI systems, ensuring compliance with industry standards and regulatory requirements.
- Prepare, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Validation Summary Reports (VSR).
- Collaborate with cross-functional teams to ensure smooth execution of validation activities and resolve any issues or challenges encountered.
- Analyze test data and recommend improvements or changes to systems as necessary.
- Ensure that all validation activities comply with GMP (Good Manufacturing Practice) and other applicable regulations.
- Provide support during internal and external audits related to validation activities.
- Keep up to date with the latest industry standards and validation techniques.
- Bachelor's degree in engineering, Life Sciences, or a related field (or equivalent experience).
- Proven experience working in aseptic environments within the biotechnology or pharmaceutical industry.
- Minimum of [X] years of experience validating packaging lines, labelers, case packers, and low-speed pen assembly systems.
- Strong expertise in SEA Vision Yudoo and AVI systems validation.
- Familiarity with regulatory guidelines such as FDA, ISO, and GMP.
- Experience developing validation plans, IQ, OQ, PQ, and VSR documentation.
- Excellent troubleshooting and problem-solving skills.
- Strong communication skills, both written and verbal.
- Ability to work independently as well as part of a team.
