Principal QA Process Validation Specialist

We are actively seeking a Principal QA Process Validation Specialist to provide technical Quality oversight and subject matter expertise for process validation activities supporting aseptically filled drug products.

This role is ideal for a Process Validation Engineer or Validation SME with strong technical expertise who can evaluate validation strategies, review engineering activities, and ensure processes are scientifically sound, compliant, and aligned with regulatory expectations.

The Principal QA Process Validation Specialist will partner closely with Process Engineering, MSAT, Manufacturing, Validation, and Quality teams to provide oversight throughout the full process validation lifecycle, including Process Design, Process Performance Qualification (PPQ), and Continued Process Verification (CPV).

This individual will leverage their hands-on process validation background to ensure validation activities, protocols, risk assessments, execution strategies, and lifecycle documentation meet both internal standards and global regulatory requirements.

This is a highly visible role for a validation professional who wants to apply their technical expertise in a Quality leadership capacity while supporting the successful validation and commercialization of aseptic drug manufacturing processes.

Key Responsibilities:

• Provide QA oversight and technical assessment of process validation activities throughout the process validation lifecycle
• PPQ and CPV ownership
• Review and approve process validation protocols, risk assessments, process flow diagrams, CPP/CQA assessments, and validation summary reports.
• Evaluate process validation engineering activities to ensure approaches are scientifically justified, technically sound, and compliant with regulatory expectations.
• Provide Quality oversight of PPQ execution, validation strategies, and ongoing process monitoring programs.
• Support identification and evaluation of Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs), process risks, and process capability assessments.
• Review process-related change controls and determine appropriate revalidation requirements.
• Support deviation investigations and CAPA activities associated with process validation activities.
• Serve as a Quality Subject Matter Expert during internal audits, client audits, and regulatory inspections.
• Assist with development and continuous improvement of validation procedures, SOPs, and quality guidance documents.
• Maintain awareness of evolving regulatory expectations and industry best practices related to process validation.

Required Qualifications:

• Bachelor’s Degree in Engineering, Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.
• 5 years of experience in pharmaceutical, biotechnology, or CDMO manufacturing environments.
• Strong hands-on experience developing and executing process validation activities, including PPQ studies.
• Deep understanding of the process validation lifecycle, including Process Design, PPQ, and Continued Process Verification.
• Experience evaluating CPPs, CQAs, process risks, statistical analysis, and process capability.
• Knowledge of FDA Process Validation Guidance, EU Annex 15, ICH Q8/Q9/Q10/Q11/Q12, and applicable GMP requirements (this portion can be taught to an extent)

Preferred Qualifications:

• Experience supporting sterile injectable or aseptic manufacturing processes.
• CDMO manufacturing experience.
• Experience with aseptic processing validation activities including media fills, hold time studies, shipping validation, and container closure integrity testing.
• Experience supporting FDA, EMA, or other regulatory inspections.
• Experience with statistical tools such as Minitab or JMP for process monitoring and trending.
• Experience supporting technology transfer and new product introduction activities.

***5 years of experience will qualify at the Senior level. 10 years of experience will qualify at the Principal level. The client is willing to entertain candidates at either the Senior or Principal level (preferably at the Principal level)***