Process Validation Consultant (SME - Biopharma)

Piper Companies is seeking an experienced and driven Process Validation SME to provide technical leadership for process validation activities supporting commercial biologics at a manufacturing site in Frederick, MD. The Process Validation SME will serve as the primary owner of site‑level process validation practices and is responsible for ensuring manufacturing processes are qualified, monitored, and maintained in a state of control in accordance with global regulatory expectations.

Responsibilities of the Process Validation SME:

• Own and lead site‑level process validation activities, including development of validation approaches that meet global regulatory expectations for commercial biologics manufacturing.
• Plan, execute, and deliver Process Performance Qualification (PPQ) campaigns, ensuring robust protocols, data integrity, deviation management, and final validation conclusions.
• Establish and manage Continued Process Verification (CPV) programs to confirm ongoing process control and support proactive risk identification and investigation strategy.
• Provide technical leadership across upstream cell culture and downstream purification operations, assessing validation impact of process changes, scale‑up, and new equipment introductions.
• Partner closely with Manufacturing, MS&T, Quality, and Regulatory teams to ensure aligned execution, complete CMC documentation, and inspection‑ready validation packages.
• Serve as the site subject‑matter expert for process validation during audits and inspections, while maintaining site procedures and mentoring developing validation scientists.
  
  

Qualifications of the Process Validation SME:

• 10 years of experience in the pharmaceutical or biotechnology industry.
• At least 8-10 years of direct involvement in process validation for GMP manufacturing.
• Strong working knowledge of regulatory expectations related to PPQ and continued verification.
• Solid understanding of upstream and downstream bioprocessing for biologic drug products.
• Demonstrated experience supporting Chemistry, Manufacturing and Controls (CMC) activities.
• Thorough knowledge of GMP principles, documentation practices, and inspection readiness.
• Proven ability to work independently, exercise critical judgment, and solve complex technical problems.
• Deep expertise in biologics manufacturing, strong knowledge of process validation requirements
• Bachelor’s degree in a scientific or engineering discipline; advanced degree preferred.
  
  

Compensation for the Process Validation SME:

• Salary: $120,000 - $150,000 commensurate with experience
• Comprehensive Benefits: Medical, Dental, Vision 401k, Paid Holidays, PTO (Paid Time Off), Sick leave required as by law
  
  

This job opens for applications on 4/22/2026. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords:

MS&T, MSAT, Manufacturing, Manufacturing Sciences & Technology, Manufacturing Sciences and Technology, Downstream, Upstream, Bioprocessing, Clinical Biologics, Biologics, GMP, Good Manufacturing Practice, Biopharmaceutical, Pharma, Biotechnology, Biotech, Commercial Product, Drug Product, Process Validation, Validation, CMC, Chemistry Manufacturing Controls, PPQ, Continued Process Verification, CPV, Process Performance Qualification, PPQ, Biologics, Regulatory, Senior Scientist, Scientist, Engineer, Cell Culture, Purification, Protein Purification, Protein Concentration, mAB, monoclonal antibodies, monoclonal antibody, SOP, Standard Operating Procedure, Deviation, Quality, Regulatory, Global Validation, Large Molecule, Biomanufacturing, Bioprocess, Engineering, PhD, Doctor of Philosophy, Principal Scientist