Job Description

Work Schedule 7 1/2 hr shift
Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

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 $69,400.00-$104,050.00.

Skills Required