Process Engineer II

Work Schedule

Standard Office Hours (40 / wk)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom : no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Loud Noises (Equipment / Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse

Job Description

The Microbiology Division provides solutions and workflow for clinical, pharmaceutical and food testing environments. The markets we serve include food manufacturers and labs, clinical and healthcare, pharma, and biotech. We manufacture culture media and other microbiological diagnostic products serving customers in the pharmaceutical, food, and clinical laboratories.

Discover Impactful Work :

The process engineering team is responsible as the SMEs over site's products and processes. The role is responsible for resolving product and process deviations and developing efficient processes in the manufacturing of in vitro diagnostic and lab use culture media.

Key Responsibilities :

Investigate non-conforming products and track results using Excel spreadsheets (Pivot Tables, PowerBI) and identify trends for RCA. Perform historical batch and literature reviews to resolve product performance (engineering, microbiology, chemistry)

Drive special projects to drive business growth, cost savings, and profitability.

Develop and improve processing methods (aseptic and non aseptic dispensing, dry blending, mixing, cooling, solubility, freeze drying, dispensing, thermal processing, formulation)

Author technical protocols and lead engineering studies.

Operate industrial processing equipment (boiling tanks, blenders, dispensers, labellers, etc) to test processes, investigate issues, and build work instructions.

Investigate process capability using Statistical DOE, Process Control, GR&R, Regression, and ANOVA (MiniTab).

Author and lead changes within QMS; deviation investigations (planned and unplanned), CAPAs, customer complaints, SOPs, Batch Manufacturing Records, etc.

Strong collaboration skills, working with department supervisors and other departments using verbal and written communication.

Minimum Requirements / Qualifications :

BS in Engineering, Microbiology, or other STEM degree required. Advanced degree a plus.

Analytical and data analysis skills with Excel and statistical software

Technical Writing

Experience with ISO 9001 and ISO 13485

Excellent communication skills, both written and verbal

Ability to handle and plan multiple projects

Outgoing and collaborative in nature

Detail Oriented

Six Sigma or Lean Manufacturing

Ability to Work on Manufacturing Floor

2+ years technical experience that includes process engineering, process development, project management.

1-5 years experience within the medical device or pharmaceutical industry

Preferred to have 2+ years direct microbiology experience within the medical device or pharmaceutical industry

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today!

Thermo Fisher Scientific is an EEO / Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.