Process Engineer II

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue over $40 billion. Our mission is to enable our customers to make the world healthier, cleaner and safer by supporting life sciences research, analytical challenges, laboratory productivity, diagnostics, and life-changing therapies.

About the role

The Process Engineer serves as the subject matter expert for the site’s products and processes, responsible for resolving product and process deviations and maintaining efficient manufacturing of in vitro diagnostic and lab-use culture media.

Responsibilities

• Review and investigate all non-conforming culture media, track results using Excel spreadsheets (Pivot Tables, PowerBI), and identify trends for root-cause analysis (RCA).
• Drive special projects to support business growth, cost savings, and profitability.
• Perform historical product batch and literature reviews to resolve product performance issues (engineering, microbiology, chemistry, equipment).
• Implement practical process improvements in manufacturing through Six Sigma and Lean manufacturing techniques.
• Develop and improve processing methods (aseptic and non-aseptic dispensing, dry blending, mixing, cooling, solubility, freeze drying, dispensing, thermal processing, formulation).
• Implement engineering controls for equipment.
• Resolve critical issues without affecting productivity, balancing short-term and long-term goals.
• Author protocols to complete engineering studies on products and processes.
• Work with industrial processing equipment (boiling tanks, blenders, dispensers, labelers, etc.) to test processes, investigate issues, and build work instructions.
• Perform statistical and data analysis (e.g., MiniTab) using Statistical DoE, Process Control, GR&R, Regression, and ANOVAs to determine process capability.
• Author and lead investigations within the Quality Management System (QMS), including deviation investigations (planned and unplanned), CAPAs, and customer complaints.
• Collaborate with department supervisors and other departments using verbal and written communication.
• Update documentation such as batch records or SOPs as required.
• Perform additional duties as needed.

Requirements

• Bachelor’s degree in Engineering (preferred) or other STEM field (non-negotiable).
• 1–5 years of technical experience in process engineering, process development, or project management.
• 1–5 years of experience within the medical device, food, or pharmaceutical industry.
• Preferred: 1–5 years of direct microbiology experience within the medical device, food, or pharmaceutical industry.
• Analytical skills, problem-solving techniques, and data analysis proficiency with Excel and statistical software.
• Technical writing experience.
• Experience with ISO 9001 and ISO 13485.
• Excellent written and verbal communication skills.
• Ability to handle and plan multiple projects.
• Outgoing, collaborative, and detail-oriented.
• Six Sigma or Lean manufacturing experience.
• Ability to work on the manufacturing floor.

Environmental Conditions

• Able to lift 40 lbs. without assistance.
• Adherence to all Good Manufacturing Practices (GMP) and safety standards.
• Cleanroom environment: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, or facial hair allowed.
• Laboratory setting with loud noises (equipment/machinery).
• Office and warehouse environments.
• Required use of PPE (safety glasses, gowning, gloves, lab coat, ear plugs, etc.).

Schedule

Standard (Monday–Friday), day shift.