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.

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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.

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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.

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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.

A top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200 Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.
Job Responsibilities:
• Conducting Post Market Activities and Post Market Surveillance
• Managing Customer and Product Complaint Investigation programs
Education and Experience:
• 1 YR. of experience in a technical role in the medical device/pharma/biotech industry
• Bachelor's degree
• Computer proficiency