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

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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

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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

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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
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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
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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

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Ability to work in cleanroom and controlled manufacturing environments when required

Benefits

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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.