02 Mar
Process Engineer-Injectables Manufacturing-Remote
Connecticut, Detroit , 06340 Detroit USA

Process Engineer-Sterile Injectable Manufacturing (Remote)The individual selected will be a key part of the Sterile Injectables Manufacturing Science and Technology Group which aims to deliver on process robustness and customer satisfaction through innovative solutions to manufacturing issues. In scope is full product life cycle support for aseptic drug products, including co-development, technical transfer, scale-up, process validation, registrations, ongoing troubleshooting and process improvements. The individual will be responsible for coordinating the development of a disposables strategy for PGS. The strategy will target the establishment and maintenance of network-wide design, quality, and operational standards, along with lifecycle management, and sourcing strategies for disposable items.

ROLE RESPONSIBILITIES: As a Single Use System Subject Matter Expert your responsibilities could include: Technical Act as Disposables SME for sites to support implementation of best practices and solutions Provide advanced technical subject matter expertise and issue resolution for major/complex investigations involving single use assemblies and components across all business units Develop processes / procedures to facilitate single use system design discussions with Network partners. Applies technical knowledge and project management skills to achieve goals of the department Ensure compliance with relevant regulations and guidance

QUALIFICATIONS: Masters or Bachelors with minimum 3-5 years in Engineering (Mechanical, Chemical, or Pharmaceutical preferred) or Life Sciences Experience Operations or Tech services experience Must have single use technologies on drug substance or drug product side with single use technology Minimum of three years' experience in project management/execution role is advantageous Knowledge of cGMP requirements and compliance Excellent communication and technical writing skills Ability to manage own time to meet agreed targets and develops plans for short-term and long-term activities

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