A Pharma Validation Engineer is responsible for ensuring that pharmaceutical manufacturing processes, equipment, and systems comply with regulatory requirements, industry standards, and company policies. They play a pivotal role in the validation lifecycle, including planning, executing, and documenting validation activities to ensure consistent and reproducible product quality and safety. This position requires a thorough understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Automated Manufacturing Practice (GAMP) guidelines.
Qualifications :
- Bachelor’s degree in Engineering, Chemistry, Biotechnology, or a related field. Advanced degree or relevant certifications (., ASQ CQE, PMP) are a plus.
- Minimum of 7 years of experience in a validation role within the pharmaceutical or biopharmaceutical industry.
- Comprehensive knowledge of GMP, GLP, GAMP, and regulatory requirements (FDA, EMA, ICH, .
- Experience with validation of laboratory equipment, manufacturing processes, cleaning processes, computerized systems, and utilities.
- Strong analytical, problem-solving, and critical-thinking skills.
- Excellent documentation, organizational, and project management skills.
- Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment.
- Ability to manage multiple projects and priorities in a fast-paced environment.
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