Process Engineer II

Work Schedule First Shift (Days) 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, Cold Room/Freezers -22degreesF/-6degrees C, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials Job Description 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. About the Site Thermo Fisher Scientific's oral solid dose (OSD) site in Cincinnati, Ohio is a large-scale, advanced manufacturing facility supported by over 800 employees. The site provides a wide range of drug development and commercial manufacturing services, including: Controlled and sustained release solid oral dosage forms Osmotic release dosage forms (laser drilling) Liquid fill hard capsules Controlled substances manufacturing Abuse-deterrent dosage forms This site plays a critical role in delivering innovative pharmaceutical solutions to customers worldwide.

Discover Impactful Work:

Join our Manufacturing Engineering team and contribute to advancing pharmaceutical manufacturing technologies and processes. As an Engineer II, Manufacturing Engineering, you will support continuous improvement initiatives, ensure compliance with quality and regulatory standards, and optimize production processes. You will collaborate cross-functionally to deliver innovative, efficient, and sustainable manufacturing solutions that directly support our mission. A Day in the

Life:

Support new product introductions and technology transfers into manufacturing Drive process improvements using data-driven and lean manufacturing methodologies Optimize equipment performance and manufacturing processes Lead and support technical projects across cross-functional teams Conduct root cause investigations and implement corrective actions Partner with operations, quality, maintenance, and R D to ensure seamless execution Maintain engineering documentation, specifications, and change control processes Support equipment qualification, validation, and calibration activities Keys to

Success:

Education Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, Industrial, or related field required) Experience Minimum 2 years of manufacturing engineering experience in a regulated industry

Knowledge, Skills, Abilities:

Working knowledge of

GMP, ISO

standards, and regulatory requirements Experience with lean manufacturing and continuous improvement methodologies Strong analytical, statistical analysis, and problem-solving skills Experience in root cause investigation and corrective action implementation Project management experience and ability to lead cross-functional initiatives Familiarity with engineering documentation and change control processes Experience with CAD software, manufacturing systems, and data analysis tools (preferred) Knowledge of automation, controls, and process validation (preferred) Understanding of equipment qualification and calibration processes Strong written and verbal communication skills Ability to mentor and train manufacturing personnel Proficiency with Microsoft Office and manufacturing software systems Physical Requirements /

Work Environment:

Ability to work in cleanroom environments and comply with PPE/gowning requirements Ability to occasionally lift up to 50 lbs with assistance

Competencies:

Analytical and detail-oriented Collaborative and team-focused Results-driven and accountable Strong problem-solving mindset Effective communicator

Benefits:

We offer competitive remuneration, an annual incentive plan bonus, healthcare, and a comprehensive range of employee benefits. Thermo Fisher Scientific provides outstanding career and development opportunities within an innovative, forward-thinking organization. Our culture is built on integrity, intensity, involvement, and innovation. Relocation assistance is not provided. Must be legally authorized to work in the United States now or in the future without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening.