Senior Process Engineer – Tech Transfer

  • Contract
  • Louth

Senior Process Engineer – Tech. Transfer

Headcount Solutions is seeking a Senior Process Engineer for a Technical Transfer position with our multinational pharmaceutical client. This person will support the execution of technology transfers, providing manufacturing process support to resolve commercial production issues, and to provide support for process and capacity optimization.

Responsibilities include:

  • Work with External Partners to achieve business goals and to establish a common culture that benefits our client company, External Partners, and patients.
  • Responsible for technical activities for the commercial manufacturing process at the External Partner, which includes 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:

  • Bachelor’s degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.
  • Must possess Drug Substance Technical Transfer Experience for this role (4/5 Years).
  • Experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance.
  • Advantageous to possess proven expertise in biologics drug substance upstream and downstream operations, analytical testing, process development and tech transfer.
  • Experience in deviation management and/or change control and/or equipment support, and/or project management.

For further information please contact Mick on 086-0435195 or forward details in confidence to jobs@headcount.ie

 

 

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