Process Engineer – Senior Technical Transfer Engineer

ref. 01256

Process Engineer – Senior Technical Transfer Engineer

Exciting opportunity with our client, a leading global pharmaceutical company, with various sites across Ireland.

With an extensive range of facilities and environments, our client's engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation, ensuring that internal and external manufacturing operations remain operational, continuously improve, and innovate.

The External Manufacturing (ExM) Technical Operation organization (accountable for technology transfers and commercial production of Biological Drug Substance at our External Partners (EPs)) is looking for a results-driven, highly motivated individual for a Technical Transfer position. In this role, you will have the opportunity to participate in all these areas. This may include supporting the execution of technology transfers, providing manufacturing process support to resolve commercial production issues, and providing support for capacity and process optimization.

The successful candidate must have experience in Drug Substance Technical Transfer activities.

Responsibilities

1. Work with External Partners to achieve business goals and to establish a common culture that benefits our company, External Partners, and patients.
2. Responsible for technical activities for the commercial manufacturing process at the External Partner, such as authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.
3. Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.
4. Support and provide on-site coverage at External Partner in support of Commercial and/or Technology Transfer Person-In-Plant Activities.
5. Ensure that External Partners are inspection ready for all routine inspections and/or inspections related to new product introductions or transfers, in concert with Operations, Quality, and Regulatory.
6. Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with Operations, Quality, and External Partners.
7. Participate in creation, sharing, and adoption of business process and best practices strategies.

Requirements

1. Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.
2. 4 years+ post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance.
3. Great communication in English and teamwork skills.
4. Travel will be a requirement at approximately 25%.

Desirable

1. Experience in deviation management and/or change control and/or equipment support, and/or project management.
2. Proven expertise in biologics drug substance upstream and downstream operations, analytical testing, process development, and tech transfer.
3. Statistics experience (including Proactive Process Analysis and Continuous Process Verification).
4. Ability to independently manage projects/work to schedule/deadlines.

* This position will be primarily home-based and can be located anywhere in Europe. *

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