Are you looking to take the next step in your career? Our pharmaceutical client is hiring a Validation Engineer II to play a vital role in ensuring compliance and supporting cutting-edge pharmaceutical manufacturing projects. Join a dynamic team and contribute to groundbreaking initiatives and meeting key project milestones in 2025 and beyond.

Apply to this ad or reach out to Jessica Goodman to learn more about this exciting opportunity!

Key Responsibilities:

• Conduct validation studies for manufacturing and packaging equipment, as well as pharmaceutical utilities like HVAC systems, USP Purified Water, and Clean Compressed Air.
• Perform routine temperature mapping studies for warehouse areas and Controlled Temperature Units (CTU).
• Develop and execute qualification/validation protocols, analyze results, and generate final reports.
• Oversee qualifications for product introductions, including filling, assembly, and secondary packaging processes.
• Mentor junior engineers and coordinate projects with validation contractors.
• Create and review risk assessments to support qualification-related activities.
• Manage project timelines, collaborate with cross-functional teams, and ensure change control compliance.

Qualifications:

• Bachelor’s degree
• 3+ years’ experience in pharmaceutical validation activities.
• Knowledge of FDA, ISO, EU, and ICH industry guidelines and cGMP practices.
• Experience in manufacturing, packaging, and lab equipment qualification is a plus.