Validation Manager

Phlow Corp • Petersburg, VA

2h

About The Position

Leadership & Strategy
Develop and implement site-wide CQV strategies aligned with regulatory and business objectives.
Cleaning validation
Stability programs
Packaging configurations for intermediate and finished goods.
Lead, mentor, and develop CQV engineers and validation specialists.
Establish validation master plans (VMPs) and lifecycle validation programs.
Manage CQV budgets, schedules, and resource planning.
Commissioning & Qualification
Oversee commissioning and qualification of:
Manufacturing equipment
Clean utilities (WFI, clean steam, compressed gases)
HVAC systems and cleanrooms
Laboratory systems
Process automation and control systems
Establish and implement cleaning validation requirements.
Establish and implement packaging configurations
Stability programs and protocols
Ensure execution of URS, FRS, DS, FAT, SAT, IQ, OQ, and PQ protocols.
Coordinate with Engineering, Quality, Manufacturing, and external vendors.
Validation Lifecycle Management
Ensure compliance with:
FDA 21 CFR Parts 210/211, 11
EU GMP Annex 1 & 15
ICH guidelines
ISPE Baseline Guides
Oversee process validation, cleaning validation, and continued process verification (CPV).
Support technology transfer and new product introductions (NPI).
Documentation & Compliance
Review and approve validation protocols and reports.
Ensure data integrity and adherence to ALCOA+ principles.
Support internal audits, regulatory inspections, and client audits.
Manage deviation investigations, CAPAs, and change controls related to CQV.
Risk Management
Apply risk-based validation approaches (ICH Q9).
Conduct and facilitate FMEAs and risk assessments.
Implement continuous improvement initiatives in validation processes.

Requirements

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, or related technical field (Master’s preferred).
• 8+ years of experience in pharmaceutical/biotech manufacturing.
• 5+ years in CQV/validation leadership role.
• Strong knowledge of GMP-regulated environments.
• Experience supporting regulatory inspections.
• Deep understanding of validation lifecycle approach.
• Strong leadership and team management skills.
• Excellent communication and stakeholder engagement abilities.
• High attention to detail and organizational skills.
• Ability to manage multiple complex projects simultaneously.

Nice To Haves

• Expertise in cleanroom and sterile manufacturing qualification (preferred).
• Knowledge of automation systems (DeltaV, Siemens, etc.).
• Familiarity with Kneat, ValGenesis, TrackWise, or similar systems (preferred).
• PMP (Project Management Professional)
• ASQ Certified Quality Engineer (CQE)
• ISPE membership or relate industry certifications

Responsibilities

• Develop and implement site-wide CQV strategies aligned with regulatory and business objectives.
• Lead, mentor, and develop CQV engineers and validation specialists.
• Establish validation master plans (VMPs) and lifecycle validation programs.
• Manage CQV budgets, schedules, and resource planning.
• Oversee commissioning and qualification of manufacturing equipment, clean utilities, HVAC systems and cleanrooms, laboratory systems, and process automation and control systems.
• Establish and implement cleaning validation requirements, packaging configurations, and stability programs and protocols.
• Ensure execution of URS, FRS, DS, FAT, SAT, IQ, OQ, and PQ protocols.
• Coordinate with Engineering, Quality, Manufacturing, and external vendors.
• Ensure compliance with FDA 21 CFR Parts 210/211, 11, EU GMP Annex 1 & 15, ICH guidelines, and ISPE Baseline Guides.
• Oversee process validation, cleaning validation, and continued process verification (CPV).
• Support technology transfer and new product introductions (NPI).
• Review and approve validation protocols and reports.
• Ensure data integrity and adherence to ALCOA+ principles.
• Support internal audits, regulatory inspections, and client audits.
• Manage deviation investigations, CAPAs, and change controls related to CQV.
• Apply risk-based validation approaches (ICH Q9).
• Conduct and facilitate FMEAs and risk assessments.
• Implement continuous improvement initiatives in validation processes.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager