Senior Process Engineer
INCOG Biopharma Services in Indianapolis, IN is hiring a Senior Process Engineer who will help lead and/or support with advancing our process improvement and operational excellence efforts to the next level. We are seeking a highly motivated individual with extensive experience leading capital projects installing and qualifying GMP pharmaceutical packaging equipment. Technologies include automated and manual visual inspection, labeling, assembly operations, cartoning, and serialization. After completion of the packaging expansion project, this role will transition into one responsible for short and long-term process improvements. The ideal candidate will have experience with biopharmaceutical based GXP manufacturing operations including technology transfers and process/equipment improvements.
The successful candidate will lead the technical team in packaging by providing 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. Additionally, the candidate must thoroughly understand and be able to adapt to the changing needs of a contract manufacturing environment.
There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.
At INCOG, we are more than just a contract development and manufacturing organization. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At our core, that is who we are—a dedicated team that believes we can always be better.
Join us at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients for yourself, our clients, and patients.
Job Functions:
- Leading the packaging equipment specification, procurement, installation and qualification activities. This includes managing portions of the capital budget and providing routine project updates.
- 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.
- 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.
- Write technical documentation (protocols & reports for equipment/instrument qualifications, comparability, process, and manufacturing process validation testing) & work with vendors and suppliers to define requirements and understand functional specifications.
Candidate Requirements:
- Knowledge of data management tools and RCM.
- Bachelor’s degree or higher in chemical, electrical, or mechanical engineering, biochemistry, bioengineering, or related scientific field.
- 5+ years’ experience in biopharmaceutical or other GXP regulated industry.
- CMO/CDMO experience
- Technical and/or lean six sigma certifications
Why INCOG?
- Paid time off, based on tenure
- 11 paid holidays
- 401(k) plan with company match up, vested immediately
- Choice of health & wellness plans
- FSA and HSA options
- Onsite wellness facility
- Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations