Description
Project Product Technology SME (Process Engineer)
Indianapolis, Indiana
Duration 6 month contract - could extend
Manpower Engineering seeking a contract Pharmaceutical Process Engineer for our global client in Indianapolis. Contract position expected to last at least 6 months, possibly longer. Monday-Friday. Open to considering non-local Engineers that could be on-site during the week (per diem).
What you will be doing:
- Support the technology transfer process team on activities related to successfully transferring current marketed drug product to a new external supplier manufacturing sites. Transfer involves multiple products from sending sites transferring to receiving manufacturing sites.
- Working knowledge of drug product formulation
- Will create better structure around SOPs and job aids by revising and updating
- Help with investigations, CAPA review
- Will be dedicated to floor support, day-to-day issues, work on reducing errors, documentation
- Challenge is around batch cadence. Currently, below 2 batches/day and looking to increase cadence to 3-4/day.
- Personnel will serve as technical lead for gathering product knowledge, conducting process fit analysis, conducting process gap analysis, collating into easily analyzed formats, generating visual outputs of data and working with other project workstreams on requested deliverables.
- Contractor will assist with generating knowledge transfer documents, technology transfer plans and other transfer related documents between sending / receiving sites
- Contractor will provide first level review of technical documents generated by receiving site and coordinate internal technical review of sending site / project SMEs.
- Contractor will participate/lead cross-functional team meetings between sending and receiving sites
- Contractor will support administrative activities for the workstream such as action/issue item tracking, generation of meeting minutes, coordination of focused working sessions between sending and receiving sites and follow up on actions.
- Contractor will be responsible for providing monthly schedule updates to master scheduler
- Contractor will interact with engineering, regulatory and laboratory workstreams
Who are we seeking?
- Technical process understanding of pharmaceutical drug products
- 5+ years' experience working in a manufacturing environment for small or large volume parenteral
- Purification experience
- Working knowledge of drug product formulation
- Knowledge of terminally sterilized and / or aseptically processed drug product
- Basic understanding of laboratory testing for Active Pharmaceutical Ingredient (API) and drug product: chemical and microbial
- Proficiency in MS Office applications
- Ability to support teleconference meetings outside normal business hours
