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Job Description
PE Global is currently recruiting for a Process Engineer (Tech Transfer). These roles are fully remote with 10% travel to the EU.
This is an initial 11-month contract position.
ROLE:
- Work with External Partners to achieve business goals and establish a common culture that benefits our company, External Partners, and patients.
- Responsible for technical activities for the commercial manufacturing process at the External Partner, including authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.
- 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.
- Provide on-site coverage at External Partner in support of Commercial and/or Technology Transfer Person-In-Plant Activities.
- Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with Operations, Quality, and External Partners.
- 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.
- Responsible for participation in creating, sharing, and adopting best practices and business process strategies.
REQUIREMENTS:
- Minimum of 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.
- Must have 3-5 years fill finish Technical Transfer experience for this role.
- Strong communication and teamwork skills.
Interested candidates should submit an updated CV.
Please click the link below to apply, or alternatively send an updated CV to
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland.***
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