Part of a team responsible for providing technical support throughout the product lifecycle for two commercial products, which includes both upstream (media preparation and cell culture) and downstream (purification and formulation) operations.  The range of product lifecycle activities includes technology transfer and scale-up, process validation, commercial operations, process monitoring, and continuous improvement.  The team, in concert with the MTS organization, is responsible for maintaining the body of process knowledge for the commercial processes and ensuring that the processes are compliant, capable and maintained in a validated state of control.  This team works in close association with the site Manufacturing, Quality, and Validation units, as well as other groups within the MTS organization.  MTS strives to attain a high level of technical expertise and knowledge of the processes we support as well as a rigorous understanding of compliance requirements and cGMP considerations required by our operations.

The Process Engineer role on the Lifecycle team is responsible for:

1. Providing direct support to the team of subject matter experts responsible for generation of a Process Control Strategy (PCS) for each product, and ensuring that the PCS is maintained to reflect process lifecycle activities at the site.

2. Developing and maintaining a site Operational Control Strategy (OCS) for each product, which includes a documented process monitoring strategy.

3. Developing an SPC program and data review schedule for each product, driving and coordinating these process monitoring activities, and documenting key findings in annual product reviews.

4. Defining, prioritizing, and coordinating process improvement activities through the conducting of process surveys and risk assessments, and through close collaboration with subject matter experts at the site.

5. Supporting Integrated Work Plan (IWP) quality systems remediation teams to move the site and commercial processes towards an improved state of compliance.

Qualifications

BS in science or engineering with at least 8 years experience in manufacturing technical support or process development for cGMP bioprocess bulk manufacturing (cell culture, purification, and/or buffer/media preparation), or MS in science or engineering with at least 6 years experience.

Preferred qualifications

Clear understanding of cGMP via experience of working in regulated biotech/pharmaceutical environment

Skilled communicator with a keen eye for detail

Experience with technology transfer

Skilled in risk management

Strong coordination, project management and planning skills

Ability to continuously look internally and externally for best practices

Sponsorhips are not available for this role.