Process Engineer II

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

About the Site

Thermo Fisher Scientifics 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

• Bachelors 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.