Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, 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.)

Job Description

Title: Senior Deviation Management Engineer

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

This role will report into the Pharma Services Group and can based near any one of our PSG sites in eastern part of North America.

Discover Impactful Work:

The Senior Deviation Management Engineer is important for maintaining compliance, continuous improvement, and operational excellence by running deviations, CAPA, and quality systems. This person leads investigations, performs root cause analysis, supports tactical performance tracking, and works across departments to reduce repeat incidents and improve product and process quality.

A Day in The Life:

Support the tactical execution of the site Quality Management System (QMS) through deviation reduction, CAPA efficiency, and continuous improvement initiatives.

Analyze deviation trends to identify systemic gaps, improvement opportunities, and training needs.

Develop and monitor benchmarks aligned with site and corporate quality objectives.

Lead and facilitate investigations for deviations, nonconformances, and quality events to resolve true root causes.

Coordinate the Deviation Reduction Program and identify process improvements to minimize recurrence.

Mentor and train Investigators in structured problem-solving methodologies and documentation guidelines.

Ensure timely completion and closure of investigations and CAPAs in compliance with regulatory and internal standards.

Collaborate with cross-functional teams to implement and verify the efficiency of corrective and preventive actions.

Collaborate with complaint handling and pharmacovigilance teams to ensure accurate and timely adverse event reporting and safety communication.

Provide technical expertise and investigation support for product-related complaints and safety events.

Ensure alignment with internal procedures and external regulatory expectations (e.g., FDA, EMA, ISO).

Drive Right First-Time initiatives passionate about process development, standardization, and error-proofing.

Employ root cause analysis and lean problem-solving techniques (e.g., 5-Why, Fishbone, DMAIC) to improve process robustness.

Partner with Manufacturing, Engineering, and Quality functions to develop and implement standard work and process improvements.

What We Will Do

Traveling up to 50%, we visit suppliers to resolve manufacturing, quality, and technical issues, and prevent future problems.

We provide supplier investigation ownership and apply enhanced problem-solving skills (six sigma) to identify true root cause, develop, and implement irreversible corrective actions. Provides efficient and effective solutions and CAPA management for supplier issues.

Lead technical aspects for suppliers, optimizing materials and services.

Responsible for communicating supplier issues to Leadership Team.

We participate in periodic business and relationship review meetings with problematic suppliers.

We serve as a primary point of contact to Thermo Fisher manufacturing sites and suppliers in the region. Influences internal partners and works across functional boundaries to identify business needs, establish standard processes, ensure alignment, and mitigate risk.

Responsible for ensuring a data-driven Global Supplier Management program that focuses on identifying and mitigating risk across the direct material supply chain.

Keys to Success: Education:

Bachelor’s degree in Engineering, Science, or Business is required.

Experience:

Extensive experience in regulated environments (GMP a plus) in Pharma, Med Device, OTC Drug, Cosmetics, Food, Automotive, or Aerospace.

Proven experience of at least 3 years in each position within a minimum of 2 of the following areas: Operations, Quality, Procurement, and/or Supply Chain Management.

Experience in data management, collection, analysis, technical writing, and driving continuous improvement with a track record of achieving result.

Benefits

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.