Validation Scientist
2 weeks ago
Job Title - Process Validation Scientist
Location – Frederick, MD
Duration – 11+ months
Job Description:
Shift: 1st Shift M- F 9 - 5 (at site)
Preferred Experience
Masters degree
6-10 years’ experience in biopharmaceutical Process Validation, Continued Process Verification role either as practitioner or Quality Assurance
Strong technical writing and collaboration
Regulatory experience is a plus
Statistics experience is a plus
• Demonstrate specific upstream cell culture and downstream purification unit operations knowledge in support of bioprocessing of large molecule biologics
• Lead Process Validation (Stage 3) activities including:
o process validation strategies
o protocols/reports review/approval
o timely generation of Chemistry Manufacturing and Controls (Client) documentation
o collaboration between Manufacturing Sciences and Technology (MS&T), Manufacturing Regulatory and Quality
o provides statistical support for product monitoring using techniques including statistical process control, process capability analysis, non-linear and linear regression and significant tests.
o process investigation PV impact assessment strategies
• Collaborate with global process validation team
• Communicate CPV trends to Quality Management and CClient teams.
• Present/defend process validation packages and strategies during audits and inspections.
• Review/approve technical reports and deliver presentations utilizing sound compliance reasoning and interpretation of the available data
Essential for the role:
• Bachelor’s Degree preferably in Science or Engineering. Master’s Degree or PhD preferred.
• At least ten (10) years of overall experience in Scientific / Biotech / Pharmaceutical field with at least five (5) years of experience in Process Validation.
• Comprehensive knowledge PPQ and CPV regulatory expectations.
• Fundamental understanding of upstream and downstream process units for biopharmaceutical products.
• Broad understanding of Chemistry Manufacturing and Controls (Client) activities and responsibilities with respect to Process Validation/Process Performance Qualification
• Knowledge of GMP manufacturing principles and documentation
• Proficient in statistical tools and techniques commonly used in the Biotech industry.
• Ability to apply critical thinking to solve problems and work independently
• Strong interpersonal and communication skills.
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