Validation Manager

About the role

As part of the Thermo Fisher Scientific team, you’ll contribute to meaningful work that makes a positive global impact by enabling customers to make the world healthier, cleaner, and safer. The role reports to the Allentown, PA site and the Clinical Trials Division (CTD), which partners with pharmaceutical and biotech customers worldwide to ensure the right patients receive the right therapies at the right dose and time. You will work in an environment that adheres to Good Manufacturing Practices (GMP) and safety standards, including cleanroom restrictions (no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair, etc.), fluctuating temperatures, office and warehouse settings, and requires the use of personal protective equipment such as safety glasses, gowning, gloves, lab coat, and ear plugs. The standard work schedule is Monday‑Friday.

Responsibilities

• Manage validation activities to ensure product quality and regulatory compliance.
• Develop validation strategy and oversee a team responsible for qualifying equipment, utilities, facilities, computer systems, and manufacturing processes.
• Ensure validation activities align with cGMP requirements while supporting new product introductions and technology transfers.
• Maintain the validated state of systems that help produce therapeutics.

Requirements

• Advanced degree plus 4 years of experience, or Bachelor's degree plus 6 years of experience in validation in pharmaceutical/biotech manufacturing or a related regulated industry.
• Preferred fields of study: Engineering, Science, Chemistry, Biology, or related technical discipline.
• 3+ years of people management or team leadership experience.
• Experience with equipment, process, cleaning, computer system, and utility validation; temperature mapping experience preferred.
• Experience with data integrity evaluation and knowledge of ALCOA++ principles.
• Experience participating in regulatory inspections and customer audits.
• Experience with validation master planning and change control systems.
• Travel up to 10% as needed.

Knowledge, Skills, and Abilities

• Expertise in risk assessment methodologies and statistical analysis.
• Demonstrated success managing complex validation projects and programs.
• Strong knowledge of cGMP regulations, particularly FDA and EU requirements.
• Proficiency with quality systems and validation documentation.
• Excellent technical writing and documentation skills.
• Strong leadership, communication, and interpersonal abilities.
• Ability to influence and collaborate across functions and levels.
• Knowledge of lean/continuous improvement methodologies.
• Proficient with standard business software applications.

Benefits

• Competitive remuneration.
• Annual incentive plan bonus scheme.
• Healthcare coverage.
• Range of employee benefits.
• Opportunity to work with an innovative, forward‑thinking organization offering outstanding career and development prospects.
• Company culture grounded in integrity, intensity, involvement, and innovation.

Schedule

Work schedule: Standard Monday‑Friday.