Senior Technical Transfer Engineer
An exciting opportunity has arisen with a leading global pharmaceutical company, operating across various sites in Ireland.
The company offers a diverse range of facilities and environments, allowing engineers to work across multiple areas, including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation.
This ensures that internal and external manufacturing operations remain operational, continuously improve, and innovate.
The External Manufacturing (ExM) Technical Operation organization is looking for a results-driven individual to fill a Technical Transfer position. In this role, you will participate in all aspects of the job, including supporting technology transfers, providing manufacturing process support to resolve commercial production issues, and optimizing capacity and processes.
The successful candidate must have experience in Drug Substance Technical Transfer activities.
Key Responsibilities:
* Work with External Partners to achieve business goals and establish a common culture that benefits the company, partners, and patients.
* Manage technical activities for commercial manufacturing processes at External Partners, such as authoring change control, managing process improvement projects, and analyzing statistical process performance.
* Author or review required GMP documentation and regulatory filings for technical transfer activities.
* Support on-site coverage at External Partners in Commercial and/or Technology Transfer Person-In-Plant Activities.
* Evaluate External Partners' readiness for routine inspections and new product introductions or transfers.
* Translate GMP requirements and current regulations into standardized work procedures in partnership with Operations, Quality, and External Partners.
* Participate in creating and sharing business process strategies.
Requirements:
* Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, Chemistry/Biology, or related science/engineering field.
* 4+ years of post-bachelor's degree experience in a GMP functional area or support of a GMP functional area.
* Excellent communication and teamwork skills.
* Able to travel approximately 25% of the time.
Desirable Qualifications:
* Experience in deviation management, change control, equipment support, and project management.
* Proven expertise in biologics drug substance upstream and downstream operations, analytical testing, process development, and tech transfer.
* Statistics experience, including Proactive Process Analysis and Continuous Process Verification.
* Ability to independently manage projects/work to schedule/deadlines.