Senior Process Validation Engineer

Senior Process Validation Engineer

We are seeking a highly skilled Senior Process Validation Engineer with strong experience in drug product manufacturing within a CDMO (Contract Development and Manufacturing Organization) environment. In this role, you will lead validation activities-process validation, technology transfers, equipment qualification, and continued process verification-for a portfolio of client-driven drug product programs.

You will work cross-functionally with Manufacturing, Quality, MS&T, and Regulatory teams to ensure processes are robust, compliant, and scalable. This is a critical, high-impact role for someone who thrives in a fast-paced, client-focused setting.

Key Responsibilities

• Lead planning and execution of process validation activities for drug product processes (e.g., aseptic filling, lyophilization, liquid/solid dosage, compounding, filtration).
• Serve as the SME for drug product validation in a CDMO environment, supporting multiple client programs simultaneously.
• Develop validation strategies, protocols (IQ/OQ/PQ), and reports in alignment with global regulatory expectations (FDA, EMA, ICH Q8/Q9/Q10/Q11).
• Partner with MS&T to support tech transfer of client processes into GMP manufacturing.
• Drive continued process verification (CPV) and ongoing monitoring programs.
• Support equipment and facility qualification as needed, including URS development and FAT/SAT activities.
• Collaborate closely with QA to ensure audit readiness and to support regulatory submissions.
• Analyze process data to identify trends, optimize processes, and reduce variability.
• Lead investigations and CAPAs related to process or validation deviations.
• Serve as a technical liaison with clients, presenting validation strategies, data, and recommendations.

Required Qualifications

• Bachelor's or Master's degree in Engineering, Pharmaceutical Sciences, Chemistry, or related discipline.
• 5-8+ years of process validation experience specifically within drug product manufacturing.
• Must have prior CDMO experience supporting client programs or multi-product operations.
• In-depth knowledge of validation lifecycle approaches, process characterization, and risk-based validation.
• Strong understanding of aseptic/sterile manufacturing, formulation, filling, or other drug product operations.
• Demonstrated experience working in a GMP-compliant environment with global regulatory frameworks.
• Excellent technical writing, communication, and client-facing skills.

Preferred Qualifications

• Experience with aseptic processing, lyophilization, or high-potency drug products.
• Proven success in fast-paced, project-driven, multi-client environments.
• Familiarity with statistical tools for validation and CPV (e.g., Minitab).
• Ability to lead cross-functional teams and mentor junior engineers.