Process Engineer 2
$83k - $86.25kScorpion Therapeutics
Responsibilities - Work with stakeholders to evaluate new/existing technologies to increase efficiency and facility throughput.
- Develop design documents (user requirement and software functional specifications) and support validation, commissioning, and qualification protocols.
- Assist with integrating equipment/technologies into the Distribute Control System (DCS) with the manufacturing suite.
- Evaluate single-use technologies; design single-use manifolds and assemblies.
- Work with vendors to develop data and validation packages.
- Facilitate procurement and implementation of approved new technologies.
- Develop business processes, guidelines, SOPs, and training for processing equipment/technologies.
- Lead equipment maintenance and life cycle plans.
- Partner with Site MSAT Manufacturing Technology & Science on global/site objectives.
- Support non-conformance/deviation investigations and provide process impact evaluations.
- Participate in technical problem/solution exchanges and internal/external audits/inspections.
- Working knowledge of cGMP and regulatory requirements for biologics/pharmaceuticals.
- Solid understanding of monoclonal antibody processing (manufacturing scale or process development).
- Experience with single-use disposable manufacturing systems.
- Ability to work independently and cross-functionally; quality/attention to detail; strong task/time management.
- Ability to organize, analyze/interpret, and communicate process data.
- Excellent oral and written communication.
- Experience in global teams/centers of excellence.
- CQV plan/protocol development and execution.
- Ability to lead projects within functional expertise.
Vacancy posted 1 day ago
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