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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.

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:

Education

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, or related technical field (Master’s preferred).

Experience

• 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.

Technical Skills

• 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).

Soft Skills

• 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.

Key Competencies

• Regulatory Compliance Expertise
• Project Management
• Risk-Based Thinking
• Cross-Functional Collaboration
• Problem Solving & Decision Making
• Continuous Improvement

Preferred Certifications:

• PMP (Project Management Professional)
• ASQ Certified Quality Engineer (CQE)
• ISPE membership or relate industry certifications

Physical Requirements

• 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.