Process Validation Consultant (SME - Biopharma)
Piper Companies, Frederick, MD, United States
Overview
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
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
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
Salary: $120,000 - $150,000 commensurate with experience
Comprehensive Benefits: Medical, Dental, Vision, 401k, Paid Holidays, PTO (Paid Time Off), Sick leave as required 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, Downstream, Upstream, Bioprocessing, GMP, Biopharmaceutical, Pharma, Biotechnology, Biotech, CMC, PPQ, CPV, Regulatory, Senior Scientist, Scientist, Engineer, Cell Culture, Purification, mAB, monoclonal antibodies, SOP, Deviation, Quality, Global Validation, Large Molecule, Biomanufacturing, Bioprocess, Engineering, PhD, Principal Scientist
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#LI-ONSITE
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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
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
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
Salary: $120,000 - $150,000 commensurate with experience
Comprehensive Benefits: Medical, Dental, Vision, 401k, Paid Holidays, PTO (Paid Time Off), Sick leave as required 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, Downstream, Upstream, Bioprocessing, GMP, Biopharmaceutical, Pharma, Biotechnology, Biotech, CMC, PPQ, CPV, Regulatory, Senior Scientist, Scientist, Engineer, Cell Culture, Purification, mAB, monoclonal antibodies, SOP, Deviation, Quality, Global Validation, Large Molecule, Biomanufacturing, Bioprocess, Engineering, PhD, Principal Scientist
#LI-BN1
#LI-ONSITE
#J-18808-Ljbffr