Process Engineer II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, 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

Company Information

About Thermo Fisher Scientific

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. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

For more information, please visit www.thermofisher.com

Job Description

Job Description

Job Title: Process Engineer

Reports To: Manager, Process Engineering

Group/Division: SDG/MBD

Career Band: 5

Job Track: Professional

Position Location: Lenexa

Number of Direct Reports: 0

Day/Shift (if applicable): Day

FLSA Status (Exempt/Non-Exempt): Exempt

Position Summary:

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

Key Responsibilities:

• Review and investigate all non-conforming culture media, track results using Excel spreadsheets (Pivot Tables, PowerBI) and identify trends for RCA.
• Drives special projects to drive business growth, cost savings, and profitability.
• Perform historical product batch and literature reviews to resolve product performance (engineering, microbiology, chemistry, equipment)
• Drives 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.
• Resolves critical issues without affecting productivity. Utilization of good judgment on short term versus long term goals.
• Author protocols to complete engineering studies on products and processes.
• Work with industrial processing equipment (boiling tanks, blenders, dispensers, labellers, etc) to test processes, investigate issues, and build work instructions.
• Proficient in statistical and data analysis (ex. MiniTab). Use Statistical DoE, Process Control, GR&R, Regression, and ANOVAs to determine process capability.
• Author and lead investigations within QMS; deviation investigations (planned and unplanned), CAPAs, and customer complaints.
• Strong collaboration skills, working with department supervisors and other departments using verbal and written communication.
• Update documentation such as batch records or SOPs, as required.
• Performs additional duties as needed.

Minimum Requirements/Qualifications:

• Possess a BS in Engineering (preferred) or other STEM degree.
• Analytical skills, good problem-solving technique 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 experience
• Ability to Work on Manufacturing Floor
• 1-5 years technical experience that includes process engineering, process development, project management.
• 1-5 years experience within the medical device, food, or pharmaceutical industry
• Preferred to have 1-5 years direct microbiology experience within the medical device, food, or pharmaceutical industry

Non-Negotiable Hiring Criteria:

• Bachelor's Degree

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.

ACCESSIBILITY/DISABILITY ACCESS

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

• This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.