INCOG BioPharma Services · 14 hours ago
Senior Process Engineer
Fishers, IN
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expINCOG BioPharma Services is a leading CDMO focused on parenteral injectable drugs. They are seeking a Senior Process Engineer to provide technical assessments and lead process improvements in a contract manufacturing environment, ensuring compliance with regulatory requirements.
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
Technical assessments, rationales and approval for engineering and process changes
Documentation pertaining to equipment lifecycle, qualification, audit responses, and validation to meet regulatory requirements
Excellent oral/written communication skills
Strong technical writing ability
Ability to lead and/or participate on teams with internal partners, customers, and vendors
Thorough understanding of and ability to adapt to the changing needs of a contract manufacturing environment
Monitor and analyze manufacturing data 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
Sterile Injectables (Formulation, aseptic filling, inspection, and/or packaging)
Knowledge of data management tools and RCM
Bachelor's degree or higher in engineering, bioengineering, or related scientific field
10+ years' experience in biopharmaceutical or other GXP regulated industry
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
Inside INdiana Business
2025-12-16
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