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Lead Candidate

Technical Transfer Engineer- 3rd Shift

Lead Candidate, Fishers, Indiana, us, 46085

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Job Overview The Technical Services & Manufacturing Science Engineer 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.

Job Functions

Develop technical documentation such as Process FMEA, Process Flow Diagrams, and Tech Transfer Plans.

Select appropriate equipment and single-use components for GMP manufacturing.

Act as Subject Matter Expert for manufacturing processes in project teams.

Author GMP manufacturing documentation including Master Batch Records, BOM, and Processing Forms.

Monitor process data, identifying trends and proposing actions.

Lead technical troubleshooting and investigations of process issues to support root cause analysis, product impact assessment and effective corrective and preventative actions.

Candidate Requirements

Bachelor’s degree in science or engineering.

2+ years in Technical Transfer for pharmaceutical or similar industry.

2+ years GMP experience.

1+ year in client-facing role.

Benefits

Paid time off, based on tenure.

11 paid holidays.

401(k) plan with company match, vested immediately.

Choice of health & wellness plans.

FSA and HSA options.

On-site wellness facility.

Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations.

Why INCOG? 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.

Equality, Diversity and Inclusion 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.

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