Sr. Spclst, Engineering

Job Description

The External Manufacturing Large Molecule Drug Product Technical Operations (ExM LM DP TO) organization is seeking a highly motivated individual for a Sr. Specialist Engineering position. ExM LM DP TO is accountable for technology transfers and commercial production of sterile drug product at our Company’s External Partners (EPs). This person will have the opportunity to lead activities in all these areas with a primary focus on commercial production.

Responsibilities include:

• Work with External Partners to achieve business goals and to establish a common culture that benefits both 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 Tech 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

Minimum Education Requirement and Experience:

• Bachelors degree in chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field with four (4) years’ experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance

Required Experience and Skills:

• Travel will be a requirement of this position at approximately 25%
• Strong communication and teamwork skills

Preferred Experience and Skills:

• Experience in sterile / aseptic manufacturing
• Demonstrated ability to independently manage projects/work to schedule/deadlines
• Statistics experience
• Experience in deviation management and/or change control and/or equipment support, and/or project management.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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