Engineer - TS/MS Cleaning Validation - Indianapolis
2 weeks ago
Job summary
The Technical Services and Manufacturing Sciences TS/MS Representative for Cleaning Validation is a technical position that supports develops and implements a technical agenda for their area of responsibility.The TS/MS Representative is responsible for providing technical leadership for activities within Indianapolis Device Assembly & Packaging IDAP including new product commercialization and commercial product support.
This position focuses specifically on Dry Packaging which includes bottle and blister card filling and packaging for tablets and capsules.,Responsibilities
- Prepare review and approve relevant technical documents such as annual product reviews change controls regulatory submissions deviations validations procedures PFDs PFMEAs etc./li>,
- Lead technical projects to improve cleaning processes compliance/benchmark with sites in the network to drive technical consistency knowledge sharing/Serve as interface with upstream suppliers/product network/Own cleaning batch records revisions ensuring they are current accurate/support equipment commissioning qualification activities required/Collaborate with Commercialization Project Manager cross-functional tech transfer team members to commercialize new products in IDAPlus understand scientific principles required for Dry Packaging operations/support regulatory submissions as needed/understand implement global requirements standards into Process Team/cleanings Provide off hours support as needed>/ul>
Job description
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