What are the responsibilities and job description for the Validation Manager position at Phlow?
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Description
Leadership & Strategy
Education
Description
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.
- 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.
- 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).
- 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.
Education
- 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.
- Expertise in cleanroom and sterile manufacturing qualification (preferred).
- Knowledge of automation systems (DeltaV, Siemens, etc.).
- Familiarity with Kneat, ValGenesis, TrackWise, or similar systems (preferred).
- 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.
- Regulatory Compliance Expertise
- Project Management
- Risk-Based Thinking
- Cross-Functional Collaboration
- Problem Solving & Decision Making
- Continuous Improvement
- PMP (Project Management Professional)
- ASQ Certified Quality Engineer (CQE)
- ISPE membership or relate industry certifications
- Majority of time spent in a manufacturing environment with potential exposure to chemicals and controlled substances.
- Must be able to wear appropriate PPE and occasionally lift up to 30 pounds.
- May be required to be on call or work off-hours to support 24/7 operations.