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Description

The Senior Process Engineer will provide technical assessments, rationales and approval for engineering and process changes as well as documentation pertaining to equipment lifecycle, qualification, audit responses, and validation to meet regulatory requirements. Shall have excellent oral/written communication skills and strong technical writing ability to lead and/or participate on teams with internal partners, customers, and vendors.

Essential Job Functions:

• Monitor and analyze manufacturing data as necessary to provide support for process improvement and investigations.

• Participate and support process FMEAs to understand process and product risks as a pre-requisite for process validation.

• Mentor and train other team members.

• Ensure successful manufacturing process comparability and process validation runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues.

• Lead and ensure systematic DMAIC based approach utilization for process/product related investigations to identify root cause and provide impact assessment to maintain routine manufacturing operations and determine process improvements for manufacturing.

• Participate and report to a cross-functional team to advance production activities.

• Participate in evaluation of new technology and process automation for introduction into GMP manufacturing.

• Write technical documentation (protocols & reports for equipment/instrument qualifications, comparability, process, and manufacturing process validation testing).

• Execute engineering studies, recipe development, and validation test cases.

• Work with vendors and suppliers to define requirements and understand functional specifications.

• Understand manufacturing needs and adapt to the changing needs of the manufacturing environment.

• Work flexible hours for the coverage of the production facility.

Additional Skills & Qualifications

CMO/CDMO experience

Technical and/or lean six sigma certifications

Electro-mechanical practical experience

Experience Level

Intermediate Level

Pay and Benefits

The pay range for this position is $80000.00 - $100000.00/yr.

medical dental vision 401k

Workplace Type

This is a fully onsite position in Fishers,IN.

Application Deadline

This position is anticipated to close on May 26, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.