Validation Engineer IV

About This Role

This role involves performing a variety of validation activities within a cGMP pharmaceutical/medical device contract manufacturing environment. The Validation Engineer IV will guide project teams and external firms on complex validation initiatives to ensure project schedules and regulatory compliance are met.

Responsibilities

• Author validation plans and oversee the development of specifications for user, functional, and design requirements, trace matrices, validation summary reports, and test protocols for installation, operation, and performance.
• Review and approve commissioning, qualification, and validation-related system lifecycle documentation.
• Provide direction on equipment/process change control development in a cGMP environment.
• Collaborate with manufacturing, engineering, quality assurance, and project management to achieve project deliverables.
• Perform periodic reviews of systems to monitor validation status and develop validation SOPs.
• Help define validation strategies based on regulations, guidance documents, and industry best practices.
• Assist management in mentoring and training colleagues on validation policies and procedures.
• Lead validation projects as a team representative on significant, complex technical initiatives.
• Perform risk assessment and mitigation steps to maintain a validated state of compliance for all equipment, utilities, processes, materials, and facilities.
• Coordinate and execute validation protocol activities, communicating effectively with affected departments.
• Write protocols and technical study approaches.
• Review document changes, deviation reports, and change controls for validation impact.
• Propose corrective actions to the validation manager and implement necessary changes.

Requirements

• Bachelor’s degree in Engineering or related scientific discipline
• 8+ years of Pharmaceutical industry experience or combination in Validation, Quality, Production, or Engineering
• Experience in pharmaceutical or biopharmaceutical environment in operations/engineering/manufacturing/quality
• Direct Validation experience with pharmaceutical or biopharmaceutical processes including strategy, master plans, protocols, and reports
• Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EMA) for validation of GMP facilities
• Strong knowledge of commissioning, qualification validation and related practices, including applicable regulations
• Excellent technical writing, verbal communication and presentation skills
• Ability to evaluate compliance issues
• Proficiency in Microsoft Office including Word, Excel, Power Point, Project

Qualifications

• Bachelor’s degree in Engineering or related scientific discipline
• Minimum of eight (8) years of Pharmaceutical industry experience or combination of work experience in Validation, Quality, Production, or Engineering.

Nice to Have

• Combination of equipment qualification, process validation, or cleaning validation experience
• QA pharmaceutical experience
• Validation experience with Thermal characterization, Vacuum physics, Heat and mass transfer, Formulation, Aseptic Filling and Lyophilization, Sterilization
• Experience in multiple regulatory inspections and knowledgeable in current industry standards and regulatory trends

Skills

* Required skills