Process Engineer

The Process Engineer will play a pivotal role in a dynamic manufacturing organization at a facility in Noblesville, Indiana. This position supports the fast-paced production of radiopharmaceutical therapeutic sterile drug products. The role involves developing solutions and implementing new technologies to enhance the reliability and quality of the manufacturing process. This includes writing and implementing change controls and corrective and preventative actions while troubleshooting equipment issues. The Process Engineer will collaborate with various departments including R&D, Project Management, Quality Assurance, Quality Control, Validation, and Manufacturing.

• Lead process reliability, troubleshooting, remediation, and improvement efforts related to manufacturing processes or equipment.
• Author deviations to investigate root causes of failure and propose corrective and preventative actions.
• Identify and support departmental change initiatives for continual process improvement, focusing on Operational Excellence, 6-Sigma, and Lean Manufacturing applications.
• Serve as a departmental driver for reliability initiatives.
• Implement process and equipment improvements through change controls and corrective and preventative actions.
• Assist in the development and maintenance of process equipment, procedures, batch records, and training materials.
• Provide documented monitoring of department processes through trending, batch run reports, and tracking via SPC (Statistical Process Control) or other tools.
• Influence proper operating procedures during manufacturing, ensuring compliance with regulations and GMP behaviors/techniques.
• Maintain operational compliance with US and international regulatory agencies and guidelines (e.g., FDA, EU, HC, TGA, PIC/S, USP, NRC, cGMP, etc.).

• Bachelor’s Degree in Engineering or a related field required. Preferred disciplines include Mechanical, Chemical, Biochemical, Biotech, or other engineering fields based on professional experience.
• Minimum of 3 years of experience as an engineer in an FDA-regulated, GMP facility. Experience in pharmaceutical fill/finish manufacturing is preferred.
• Experience leading formal Root Cause Analysis and problem-solving methodologies.
• Verifiable knowledge and experience in the application of cGMPs, validation, quality systems, document control, and regulatory considerations impacting engineering initiatives.
• Strong oral and written communication skills with proven ability to communicate effectively in high-pressure environments.
• Agile approach with a willingness to learn new things and work dynamically.

• Experience with aseptic techniques, regulatory requirements, and validation activities needed for manufacturing parenteral products is preferred.
• Applied knowledge of necessary behaviors and techniques associated with pharmaceutical production is preferred.
• Experience with radioactive isotopes and radiation safety programs is preferred.
• Willingness to consider experience in other highly regulated environments (e.g., PSM, high hazard, NRC).

The position follows a work schedule from Saturday through Wednesday, midnight to 9 am. Training will occur during the first shift, Monday to Friday. The role supports production in a manufacturing facility and will require availability on holidays, weekends, and overtime. Training hours are scheduled until mid-June. A first shift opening from Monday to Friday, 6 am to 3 pm, is also available.

This is a Permanent position based out of Noblesville, IN.

The pay range for this position is $80000.00 - $92000.00/yr.

- Medical coverage - Dental and vision benefits - 401 (K) - Paid time off (PTO) & Paid Holidays

This is a fully onsite position in Noblesville,IN.

This position is anticipated to close on Mar 31, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $80,000 - $92,000