Responsibilities:
- Support design, development, and procurement of single-use instrumentation and assemblies for the manufacturing network.
- Develop support testing for materials of construction/design to meet processing requirements.
- Expand leachable/extractables program to support commercialization.
- Create validation documentation and prepare vendor/component documentation.
- Provide technical support for NC and CAPA investigations with Site MSAT and Manufacturing Operations.
- Evaluate new materials for autoclaved and pre-sterilized vendor components.
- Work with stakeholders to evaluate technologies/components to improve efficiency and throughput.
- Create qualification documents and commissioning/qualification protocols.
- Produce assessment/test/technical reports to determine feasibility and justification.
- Collaborate on fit/form/function of client processes in the manufacturing platform.
- Design and manufacture single-use bags/flow paths with Process Engineers.
- Partner with vendors on data and validation packages.
- Facilitate procurement/implementation of approved single-use technologies.
- Lead single-use expiry and life-cycle plans.
- Participate in deviation/non-conformance investigations and internal/external audits/inspections.
Position Requirements:
- BS in engineering/sciences/life science engineering; 2β5 years relevant experience (or MS).
- Working knowledge of cGMP and regulatory requirements for biologics/pharmaceuticals.
- Solid understanding of monoclonal antibody processing at manufacturing scale and associated equipment.
- Experience with single-use disposable manufacturing systems.
- Working knowledge of large-scale autoclave systems.
- Quality focus, attention to detail, organization/time management.
- Ability to organize/analyze/communicate investigation data; strong interpersonal/team skills; excellent oral/written communication.
Preferred Qualifications:
- Continuous manufacturing experience/knowledge.
- Experience in global teams/center of excellence.
- CQV (commissioning/qualification) plan/protocol development and execution.