Validation Engineering Specialist III

Discover Impactful Work

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

Day in the Life

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

Keys to Success

Education

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

Experience

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, Skills, and Abilities

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

Physical Requirements / Work Environment

Ability to work in cleanroom and controlled manufacturing environments when required

Benefits

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

The salary range estimated for this position based in Canada is $69,–$104,