INCOG BioPharma Services · 20 hours ago
Senior Process Engineer
Fishers, Indiana
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expINCOG BioPharma Services is a world-class CDMO for parenteral injectable drugs, committed to technical excellence and a service-culture mindset. The Senior Process Engineer will provide technical assessments and approvals for engineering changes, lead process improvement initiatives, and ensure compliance with regulatory requirements in a manufacturing environment.
BiopharmaBiotechnologyManufacturingPharmaceutical
Responsibilities
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
Qualification
Required
Bachelor's degree or higher in engineering, bioengineering, or related scientific field
10+ years' experience in biopharmaceutical or other GXP regulated industry
Excellent oral/written communication skills
Strong technical writing ability
Ability to monitor and analyze manufacturing data
Experience with process FMEAs
Mentoring and training experience
Experience with manufacturing process comparability and process validation
Experience with DMAIC based approach for investigations
Ability to participate in cross-functional teams
Experience with evaluation of new technology and process automation
Ability to write technical documentation (protocols & reports)
Experience executing engineering studies, recipe development, and validation test cases
Ability to work with vendors and suppliers
Ability to adapt to changing manufacturing needs
Willingness to work flexible hours
Preferred
CMO/CDMO experience
Technical and/or lean six sigma certifications
Electro-mechanical practical experience
Company
INCOG BioPharma Services
Our services include injectable drug product formulation development, analytical method development, process scale up, and formulation & filling of vials, syringes and cartridges.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$86.63M2024-05-29Series B· $42.86M
2022-05-10Undisclosed· $15M
2022-05-10Debt Financing
Leadership Team
Tedd Green
Co-founder & Chief Operating Officer
Recent News
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2025-12-16
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