VALIDATION ENGINEER IV

About the Role

The Validation Engineer IV performs a range of well-defined validation activities supporting cGMP pharmaceutical and medical device contract manufacturing across multiple facilities. This role collaborates with validation management to guide internal project teams and external validation firms on large or complex validation and qualification initiatives while ensuring project schedules are met. The position also contributes to a positive and equitable working environment aligned with PCI Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.

Responsibilities

• Author validation plans, oversee, and provide direction in developing specifications for user requirements, functional requirements, design requirements, trace matrices, validation summary reports, and test protocols (IQ/OQ/PQ) for equipment, utilities, and processes.
• Review and approve commissioning, qualification, and validation-related system lifecycle documentation, including user requirements, functional and design specifications, and qualification protocols.
• Provide direction on equipment and process change control development in a cGMP environment.
• Collaborate cross-functionally with Manufacturing, Engineering, Critical Utilities, Quality Assurance, and Project Management to achieve project deliverables.
• Perform periodic reviews of systems to monitor validation status and develop validation SOPs.
• Define validation strategies based on regulations, guidance documents, industry practices, and experience.
• Mentor and train colleagues on validation policies and procedures.
• Lead validation projects requiring complex technical solutions.
• Develop and recommend science-based solutions with a focus on continuous improvement and compliance.
• Perform risk assessments and mitigation steps to maintain a validated state of compliance for equipment, utilities, processes, materials, and facilities.
• Coordinate and execute validation protocol activities with effective communication across departments, working autonomously while keeping stakeholders updated.
• Write protocols and technical study approaches.
• Review document changes and deviation reports for validation impact.
• Review and approve change controls, proposing corrective actions as needed.

Requirements

• Bachelor’s degree in Engineering or a related scientific discipline with a minimum of eight (8) years of pharmaceutical industry experience or equivalent work experience in Validation, Quality, Production, or Engineering.
• Experience in pharmaceutical or biopharmaceutical environments in operations, engineering, manufacturing, or quality.
• Direct validation experience with pharmaceutical or biopharmaceutical processes, including strategy development, master plans, protocols, and reports.
• Validation experience with thermal characterization, vacuum physics, heat and mass transfer, formulation, aseptic filling, lyophilization, or sterilization is highly preferred.
• Experience in multiple regulatory inspections and knowledge of current industry standards and regulatory trends related to validation.

Skills

• Knowledge of industry guidelines (ISPE, PDA) and US/international regulations (FDA, ICH, ISO, EMA) for GMP facility validation.
• Strong knowledge of commissioning, qualification, validation, and related practices, including applicable regulations.
• Excellent technical writing, verbal communication, and presentation skills.
• Technical understanding of pharmaceutical/biotechnology unit operations.
• Ability to evaluate compliance issues and perform risk assessments.
• Strong team development and leadership skills.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Project).
• Organized, results-oriented, and capable of working in a dynamic CMO environment.
• Professional, collaborative, and strong interpersonal skills.
• Self-motivated with the ability to meet goals with minimal supervision.