Process Engineer

Job Title: Process Engineer

Job Description

This position supports the fast-paced production of pharmaceutical therapeutic sterile drug products. The Process Engineer will be responsible for developing solutions and implementing new technologies to enhance the reliability and quality of the manufacturing process. This includes writing and implementing change controls, corrective and preventative actions, and troubleshooting equipment issues. Collaboration with cross-functional teams, including R&D, Project Management, Quality Assurance, Quality Control, Validation, and Manufacturing, is a key aspect of this role.

Responsibilities

• Lead process reliability, troubleshooting, remediation, and improvement efforts related to manufacturing processes or equipment.
• Author deviations to investigate root causes of failures and propose corrective and preventative actions to eliminate those root causes.
• Identify and support departmental change initiatives for continual process improvement, focusing on Operational Excellence, 6-Sigma, and Lean Manufacturing applications.
• 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 adequate and documented monitoring of departmental processes through trending, batch run reports, and tracking using SPC (Statistical Process Control) or other tools.
• Influence and ensure compliance with proper operating procedures during manufacturing, adhering to regulations and GMP behaviors/techniques.
• Maintain operational compliance with US and international regulatory agencies and guidelines.

Essential Skills

• Bachelor’s Degree in Engineering or related field required (Mechanical, Chemical, Biochemical, Biotech, or other engineering disciplines considered based on experience).
• 3+ years of experience working as an engineer in an FDA-regulated, GMP facility; experience in pharmaceutical fill/finish manufacturing 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 understanding regulatory considerations on engineering initiatives.
• Strong oral and written communication skills with proven ability to communicate effectively at all levels in high-pressure environments.
• Agile approach and willingness to learn new things – ability to work in a dynamic setting.

Additional Skills & Qualifications

• Experience in aseptic technique, regulatory requirements, and validation activities for manufacturing parenteral products preferred.
• Experience with radioactive isotopes and radiation safety programs is preferred.

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

This position is anticipated to close on Apr 7, 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.