11 month contract position – this role is fully remote. Travel 25-40% depending on project phase. Candidates must be able to freely travel within EU, Switzerland.

Purpose

Our engineers help ensure that internal and external manufacturing operations remain operational, continuously improve, and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation.

Responsibilities

Work with External Partners to deliver technical transfer of our vaccine and biologics programs.
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

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.
Travel will be a requirement of this position at approximately 25-40%.
Strong communication and teamwork skills.
Experience in Fill Finish activities – (Vial / Syringe finish, Sterilization, cleaning aseptic manufacturing, etc.)
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.