Quality Engineer 2
Our client is the go to drug delivery expert in the pharmaceutical industry with expertise in nasal, pulmonary, injectables, eye care, transdermal and other drug delivery routes.
The Quality Engineer II is primarily responsible for leading design and execution of validation activities and supporting the implementation of new or existing manufacturing (e.g. Injectable Elastomeric Stoppers, Injection Molding, Assembly), analytical testing equipment and/or or facility related systems (e.g. Cleanroom), in accordance with defined requirements, and customer expectations. The QE will bring high level of quality mindset to validations and design transfer, ensuring these activities are thoroughly executed and properly documented in compliance with ISO 15378. The QE will also be involved in leading or supporting continuous improvement and risk management as-needed.
- Preparing and/or reviewing of validation protocols/reports (e.g. IQ, OQ, PQ)
- Responsible for leading and executing validation activities in a fast-paced cGMP manufacturing environment: review and approve executed qualification /validation documents, for facilities, processes, and equipment.
- Conduct, and/or participate, in deviation investigations to identify root causes and define corrective/ preventative actions (CAPAs).
- Organize engineering runs and validation activities with cross-functional teams to meet project objectives. Lead training of cross-functional teams involved in validation.
- Support the review and evaluation of system design requirements (e.g. URS) and design phase implementation initiatives (e.g. FAT/SAT)
- Support process and product improvement initiatives and analyze product performance to identify trends as necessary.
- Supporting the evaluation of existing system modifications to evaluate risk, establish and implement a qualification strategy, as applicable to the specific change
- Liaise with European design centers to ensure that design transfer and validation practices align with global requirements.
- Bachelor’s degree or equivalent in an Engineering or other technical discipline.
- 5+ years’ in Quality related role, with validation experience
- Experience from design conception through commercial implementation (e.g. URS, DQ, FAT, SAT, IQ, OQ, PQ) desired.
- Experience data collection and statistical data analysis (e.g. capability analysis)
- Knowledge and experience with Change Controls, CAPAs, Quality Risk Management, FMEA.
- Knowledge of Computerized System Validation (CSV) and Data Integrity Principles is desired (e.g. GAMP5 and 21 CFR Part 11).
- Experience in Facilities related validations is desired (e.g. Cleanrooms)
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