Validation Engineering Specialist III

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Every day, our colleagues bring our Mission to life—enabling our customers to make the world healthier, cleaner, and safer.

In this role, you will join our Validation Engineering team, supporting pharmaceutical manufacturing operations by ensuring product quality, regulatory compliance, and robust validation strategies that help enable life-changing therapies for patients around the world.

Our Whitby, Ontario Site specializes in commercial manufacturing for a full range of conventional dosage forms with specialized capabilities, and houses a fully integrated pharmaceutical development services (PDS) facility.

The Whitby site is a Center of Excellence, offering extensive commercial scale tech transfer experience for a variety of product types, including:

• Explosion-proof manufacturing
• Controlled substances
• Solvent granulation
• Powder filling

• Lead complex validation projects for pharmaceutical manufacturing and packaging processes, including serialization

• Author, review, and execute validation documentation (IQ, OQ, PQ) in compliance with cGMP and global regulatory standards

• Perform and evaluate risk assessments using established methodologies and statistical analysis tools

• Validate manufacturing equipment, utilities, cleaning processes, and computer systems

• Collaborate cross-functionally with Engineering, Quality, Operations, and Clients to ensure successful project execution

• Provide technical expertise and support during client and regulatory inspections (FDA, EMA, ISO)

• Contribute to continuous improvement initiatives and lean manufacturing efforts

• Mentor and support junior team members within the validation organization

• Troubleshoot complex issues using advanced root cause analysis techniques

• Advanced Degree with a minimum of 3 years of validation experience
  OR

• Bachelor's Degree with a minimum of 5 years of validation experience

• Preferred fields of study: Engineering, Life Sciences, Chemistry, or related technical discipline

• Proven experience in validation within pharmaceutical, biotech, or similarly regulated manufacturing environments

• Hands-on experience writing and executing IQ/OQ/PQ protocols

• Demonstrated ability to lead complex validation projects and coordinate cross-functional teams

• Experience supporting regulatory inspections and client audits preferred

• Familiarity with lean manufacturing and continuous improvement methodologies

Knowledge

• Strong working knowledge of cGMP regulations, including FDA, EMA, and ISO requirements

• Expertise in risk assessment methodologies and validation best practices

Skills

• Advanced technical writing and documentation skills

• Proficiency with MS Office, validation systems, and statistical analysis software

• Strong verbal and written communication skills

Abilities

• Ability to analyze complex problems and implement effective solutions

• Capability to work independently while collaborating effectively across teams

• Flexibility to support extended hours or alternate shifts based on project needs

• Ability to work in cleanroom and controlled manufacturing environments when required

We offer competitive remuneration, an annual incentive plan, healthcare, and a comprehensive range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization and outstanding career development opportunities.

Our benefits include:

• Medical, Dental, & Vision benefits – effective Day 1

• Paid Time Off & Designated Paid Holidays

• Retirement Savings Plan

• Tuition Reimbursement

Compensation