Senior Technical Services Engineer

Senior Technical Services & Manufacturing Engineer

INCOG Biopharma Services in Indianapolis, IN is hiring a Senior Technical Services & Manufacturing Engineer. They will be responsible for supporting all facets of Tech Transfer, Process Validation, GMP Floor Support, and Continued Process Verification in accordance with current good manufacturing (cGMP) for clinical and commercial programs.

This role will provide strong technical oversight to the business to ensure robust and reliable production processes are established. The TSMS Engineer is responsible for scaling up and transferring processes into full scale manufacturing process based on data generated internally or received from the client.

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, they are more than just a CDMO. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At their core, that is who they are—a dedicated team that believes they can always be better.

Join the team at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients, for yourself, and for INCOG’s clients.

Job Functions:

• Select appropriate equipment and single-use components for GMP manufacturing and develop technical documentation such as Tech Transfer Plan, Gap Assessment, Process Flow Diagram and Process FMEA.
• Represents MSAT in project teams and communicates directly with customers.
• Recognized as Subject Matter Expert for the manufacturing processes.
• Author GMP manufacturing documentation including Master Batch Records, Bill of Materials and Processing Forms.
• Monitor Process Data, identify trends and propose actions as necessary.
• Leads technical troubleshooting and investigations of process issues to support root cause analysis, product impact assessment and effective corrective and preventive actions.
• Provide technical guidance and oversight to Operations and Validation group to support Process Performance Qualification and Continuous Process Verification.
• Collaborate with cross-functional team to assess and implement new technology for GMP manufacturing.
• Able to assess impact of changes to the product, process, equipment, procedures and/or materials.

Candidate Requirements:

• Bachelor’s degree in science or engineering.
• 5+ years GMP experience within pharmaceutical manufacturing required.
• Experience in Technical Transfer for pharmaceutical or related industry required.
• Master’s degree in science or engineering is preferred but not required.

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

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.