Validation Engineering Specialist III

Job Description

<p><b>Work Schedule</b></p>7 1/2 hr shift<p><b>Environmental Conditions</b></p>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.)<p><b>Job Description</b></p><h2><b>Discover Impactful Work</b></h2><p>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.</p><p>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.</p>

<p>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.</p><p>The Whitby site is a Center of Excellence, offering extensive commercial scale tech transfer experience for a variety of product types, including:</p><ul><li>Explosion-proof manufacturing</li><li>Controlled substances</li><li>Solvent granulation</li><li>Powder filling</li></ul><h2><b>Day in the Life</b></h2><ul><li><p>Lead complex validation projects for pharmaceutical manufacturing and packaging processes, including serialization</p></li><li><p>Author, review, and execute validation documentation (IQ, OQ, PQ) in compliance with cGMP and global regulatory standards</p></li><li><p>Perform and evaluate risk assessments using established methodologies and statistical analysis tools</p></li><li><p>Validate manufacturing equipment, utilities, cleaning processes, and computer systems</p></li><li><p>Collaborate cross-functionally with Engineering, Quality, Operations, and Clients to ensure successful project execution</p></li><li><p>Provide technical expertise and support during client and regulatory inspections (FDA, EMA, ISO)</p></li><li><p>Contribute to continuous improvement initiatives and lean manufacturing efforts</p></li><li><p>Mentor and support junior team members within the validation organization</p></li><li><p>Troubleshoot complex issues using advanced root cause analysis techniques</p></li></ul><h2><b>Keys to Success</b></h2><h3><b>Education</b></h3><ul><li><p>Advanced Degree with a minimum of <b>3 years</b> of validation experience<br><b>OR</b></p></li><li><p>Bachelor's Degree with a minimum of <b>5 years</b> of validation experience</p></li><li><p>Preferred fields of study: Engineering, Life Sciences, Chemistry, or related technical discipline</p></li></ul><h3><b>Experience</b></h3><ul><li><p>Proven experience in validation within pharmaceutical, biotech, or similarly regulated manufacturing environments</p></li><li><p>Hands-on experience writing and executing IQ/OQ/PQ protocols</p></li><li><p>Demonstrated ability to lead complex validation projects and coordinate cross-functional teams</p></li><li><p>Experience supporting regulatory inspections and client audits preferred</p></li><li><p>Familiarity with lean manufacturing and continuous improvement methodologies</p></li></ul><h3><b>Knowledge, Skills, and Abilities</b></h3><p><b>Knowledge</b></p><ul><li><p>Strong working knowledge of cGMP regulations, including FDA, EMA, and ISO requirements</p></li><li><p>Expertise in risk assessment methodologies and validation best practices</p></li></ul><p><b>Skills</b></p><ul><li><p>Advanced technical writing and documentation skills</p></li><li><p>Proficiency with MS Office, validation systems, and statistical analysis software</p></li><li><p>Strong verbal and written communication skills</p></li></ul><p><b>Abilities</b></p><ul><li><p>Ability to analyze complex problems and implement effective solutions</p></li><li><p>Capability to work independently while collaborating effectively across teams</p></li><li><p>Flexibility to support extended hours or alternate shifts based on project needs</p></li></ul><h2><b>Physical Requirements / Work Environment</b></h2><ul><li><p>Ability to work in cleanroom and controlled manufacturing environments when required</p></li></ul><h2><b>Benefits</b></h2><p>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.</p><p><b>Our benefits include:</b></p><ul><li><p>Medical, Dental, & Vision benefits – effective Day 1</p></li><li><p>Paid Time Off & Designated Paid Holidays</p></li><li><p>Retirement Savings Plan</p></li><li><p>Tuition Reimbursement</p></li></ul><p><b>Compensation</b></p>The salary range estimated for this position based in Canada is $69,400.00–$104,050.00.