18393 – Process Engineer – Cork Contractor

Purpose

The External Manufacturing (ExM) Technical Operation organization is seeking a highly motivated individual for a Technical Transfer position. ExM Tech Ops is accountable for technology transfers and commercial production of Large Molecule Drug Substance at our External Partners (EPs).  This person 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 to provide support for process and capacity optimization.

Responsibilities

• Work with External Partners to achieve business goals and to 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, 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 Have Drug Substance Technical Transfer Experience for this role.
• 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
• Travel will be a requirement of this position at approximately 25%
• Strong communication and teamwork skills
• Proven expertise in biologics drug substance upstream and downstream operations, analytical testing, process development and tech transfer.
• Demonstrated ability to independently manage projects/work to schedule/deadlines
• Statistics experience (including Proactive Process Analysis and Continuous Process Verification)
• Experience in deviation management and/or change control and/or equipment support, and/or project management.