Validation Team Lead

Validation Team Lead Engineering Ocean County, NJ, US Added - 18/11/2024 Apply for Job Our Client, a leading contract development and manufacturing organization (CDMO) for pharmaceutical and biotech companies, is seeking a Validation Engineer to join their growing team. Position Overview This role manages validation activities for equipment, critical utilities (e.g., WFI, compressed gases, clean steam), and facilities, supporting drug development and manufacturing. Responsibilities include creating and approving qualification protocols, ensuring compliance with regulatory standards, managing timelines. Duties Lead validation for equipment, utilities, and facilities. Analyze data and ensure processes meet regulatory standards (FDA, ISO, EMA). Schedule activities, manage resources, and meet project deadlines. Collaborate with clients on deliverables and timelines. Support investigations and technical troubleshooting. Requirements Bachelor’s degree in Science, Engineering, or related field (advanced degree preferred). 5 years of validation experience in an aseptic pharmaceutical/biotech environment. Knowledge of FDA, GMP, ISO, EU, and ICH guidelines We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.