Process Expert M-Th 12pm-10am
About The Position
The Process Expert provides frontline support to manufacturing teams and serves as a subject matter expert in product and process knowledge. The role helps resolve product and process issues, investigate issues to determine root cause, support corrective and preventive actions, and partner with production teams to ensure batches are manufactured safely and in compliance with established instructions and quality requirements. This is a shift-based, onsite role in Indianapolis, Indiana, with a Monday-through-Thursday schedule from 12 p.m. to 10 p.m. Relocation support is not available. The role supports manufacturing excellence and the safe, high-quality production of critical therapies. It maintains manufacturing documentation, supports ongoing process verification and validation, helps keep processes inspection-ready, and provides production teams with training, knowledge sharing, and guidance.
Requirements
- Bachelor's degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry, or relevant experience in lieu of a degree.
- At least 3 years of experience in a process-support, shop-floor role within cGMP manufacturing and/or Quality Assurance and/or Quality Control.
- Demonstrated understanding of pharmaceutical processes, Good Manufacturing Practice requirements, and applicable regulatory considerations.
- Strong awareness of quality issues and ability to support quality-focused manufacturing operations.
- Excellent technical writing skills, including experience supporting manufacturing documentation.
- Knowledge of root cause analysis, corrective and preventive actions, change control, and Good Documentation Practice.
Nice To Haves
- Previous radiopharmaceutical experience.
Responsibilities
- Manage and maintain manufacturing documentation, including Master Batch Records, applicable SOPs, risk assessments, protocols, and other required documentation.
- Write and review technical documentation supporting manufacturing operations, including SOPs, batch records, and white papers.
- Collect data for ongoing process verification (OPV), evaluate product performance, and support implementation of corrective and preventive actions.
- Author, own, and ensure completion of investigations involving material transfer, API synthesis, formulation, filling, inspection, and packaging.
- Ensure manufacturing processes are inspection-ready and support process optimization and introduction of new technology.
- Review validation protocols and reports and support execution of process validations and short-term improvement projects.
- Provide guidance and support to production teams through training, knowledge sharing, and leadership to drive processes through completion.
- Help resolve product and process issues and drive investigations to determine root cause.
- Partner with production teams to ensure batches are manufactured safely and in compliance with established instructions and quality requirements.
Benefits
- Performance-based cash incentive.
- Depending on role level, eligibility to be considered for annual equity awards.
- Health benefits.
- Life benefits.
- Disability benefits.
- 401(k) with company contribution and match.
- Vacation, personal days, holidays, and other leaves.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
