Validation Engineer II

Role: Validation Engineer II responsible for executing validation protocols and supporting equipment, utility systems, and facilities in an FDA-regulated biopharmaceutical environment. Main objectives include ensuring compliance with cGMPs, developing validation strategies, and collaborating cross-functionally to meet quality and regulatory standards. Responsibilities encompass protocol development, execution (IQ/OQ/PQ), report generation, risk assessments, and vendor coordination. Qualifications: Bachelor’s in science or related discipline; 3+ years in validation or GMP environments; experience with facility and equipment validation and commissioning. Preferred skills include strong documentation, understanding of validation principles, GMPs, change control, and regulatory compliance (21 CFR Part 11). High-value specifics: validation of laboratory and manufacturing equipment, utilities, and facilities; working in on-site environments requiring PPE; familiarity with automated biopharma processing and cleanroom standards. The role reports to a manager or department head and involves working onsite with physical tasks such as lifting up to 50 pounds. Compensation ranges from $103,500 to $115,000 annually, based on experience.