Senior Deviation Management Engineer EMEA

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.

Location:

This role will report into the Pharma Services Group in the US and can based near any one of our PSG EMEA or North America.

Key Responsibilities

• Support the global 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 train and coach Investigators and Approvers in effective root cause analysis problem-solving methodologies and documentation guidelines.
• Provide oversight for 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 30% we deploy to stakeholder sites to support resolution / prevention of Quality events and implementation of global processes.
• We support investigations through enhanced problem-solving skills (six sigma) to identify true root cause and provide efficient and effective solutions through corrective/preventative actions.
• Responsible for communicating significant Quality events and negative trends in performance metrics to Leadership Team.
• We serve as a global partner to PSG network.
• 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 Deviation and CAPA Management programs that focuses on identifying and mitigating risk across PSG.

How you will get here

Education:

• Bachelors degree in Engineering or Science.

Minimum requirements

• 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/Manufacturing or Quality.
• Experience in deviation and CAPA management data management collection analysis technical writing and driving continuous improvement with a track record of achieving result.

Benefits:

• Competitive salary annual bonus
• Comprehensive health wellness and retirement benefits
• Career advancement opportunities within a global organisation

Apply today!

About Thermo Fisher Scientific:We are a global leader in scientific innovation and record over$40 billion in revenue and with an industry-leading R&D investment we are committed to making the world healthier cleaner and safer.