EPM Scientific ยท 6 days ago
Senior Process Validation Engineer
Fargo, ND
Full-time
Onsite
Senior Level
5+ years expEPM Scientific is seeking a highly skilled Senior Process Validation Engineer with strong experience in drug product manufacturing within a CDMO environment. In this role, you will lead validation activities and work cross-functionally with Manufacturing, Quality, MS&T, and Regulatory teams to ensure processes are robust, compliant, and scalable.
BiotechnologyRecruiting
Hiring Manager
Ashley Cavic
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
Qualification
Required
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
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
Company
EPM Scientific
EPM Scientific is proud to be a leading specialist recruitment agency for the life sciences industry.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
S
Sean P.
Senior Vice President Commercial - Field at EPM Scientific
Recent News
BioSpectrum Asia
2023-12-23
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