Description:
Leadership & Strategy
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Develop and implement site-wide CQV strategies aligned with regulatory and business objectives.
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Cleaning validation
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Stability programs
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Packaging configurations for intermediate and finished goods.
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Lead, mentor, and develop CQV engineers and validation specialists.
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Establish validation master plans (VMPs) and lifecycle validation programs.
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Manage CQV budgets, schedules, and resource planning.
Commissioning & Qualification
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Oversee commissioning and qualification of:
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Manufacturing equipment
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Clean utilities (WFI, clean steam, compressed gases)
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HVAC systems and cleanrooms
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Laboratory systems
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Process automation and control systems
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Establish and implement cleaning validation requirements.
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Establish and implement packaging configurations
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Stability programs and protocols
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Ensure execution of URS, FRS, DS, FAT, SAT, IQ, OQ, and PQ protocols.
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Coordinate with Engineering, Quality, Manufacturing, and external vendors.
Validation Lifecycle Management
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Ensure compliance with:
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FDA 21 CFR Parts 210/211, 11
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EU GMP Annex 1 & 15
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ICH guidelines
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ISPE Baseline Guides
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Oversee process validation, cleaning validation, and continued process verification (CPV).
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Support technology transfer and new product introductions (NPI).
Documentation & Compliance
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Review and approve validation protocols and reports.
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Ensure data integrity and adherence to ALCOA+ principles.
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Support internal audits, regulatory inspections, and client audits.
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Manage deviation investigations, CAPAs, and change controls related to CQV.
Risk Management
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Apply risk-based validation approaches (ICH Q9).
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Conduct and facilitate FMEAs and risk assessments.
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Implement continuous improvement initiatives in validation processes.
Requirements:
Education
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Bachelor’s degree in Engineering, Pharmaceutical Sciences, or related technical field (Master’s preferred).
Experience
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8+ years of experience in pharmaceutical/biotech manufacturing.
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5+ years in CQV/validation leadership role.
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Strong knowledge of GMP-regulated environments.
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Experience supporting regulatory inspections.
Technical Skills
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Deep understanding of validation lifecycle approach.
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Expertise in cleanroom and sterile manufacturing qualification (preferred).
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Knowledge of automation systems (DeltaV, Siemens, etc.).
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Familiarity with Kneat, ValGenesis, TrackWise, or similar systems (preferred).
Soft Skills
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Strong leadership and team management skills.
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Excellent communication and stakeholder engagement abilities.
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High attention to detail and organizational skills.
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Ability to manage multiple complex projects simultaneously.
Key Competencies
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Regulatory Compliance Expertise
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Project Management
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Risk-Based Thinking
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Cross-Functional Collaboration
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Problem Solving & Decision Making
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Continuous Improvement
Preferred Certifications:
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PMP (Project Management Professional)
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ASQ Certified Quality Engineer (CQE)
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ISPE membership or relate industry certifications
Physical Requirements
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Majority of time spent in a manufacturing environment with potential exposure to chemicals and controlled substances.
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Must be able to wear appropriate PPE and occasionally lift up to 30 pounds.
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May be required to be on call or work off-hours to support 24/7 operations.
