Manufacturing Support Scientist/Engineer (Contract Role)
A state-of-the-art multi-product biologics manufacturing facility is seeking to recruit a contract Manufacturing Support Scientist/Engineer. This role reports to the Associate Director for new product introduction within the Manufacturing group. The Manufacturing Support Scientist/Engineer for New Products is a key contributor to sustainable biologics manufacturing capacity within the global network.

Responsibilities
The role will include (but is not limited to):

• Contributing to cross-functional teams (Manufacturing, Engineering, QA, QC, Regulatory, Supply Chain, etc.) for process improvement implementations, new product start-ups, or other process changes.

• Supporting new product introduction risk assessments to ensure appropriate controls are in place to enable manufacturing.

• Facilitating product changeover protocols to allow a smooth transition from sustaining to new product manufacturing.

• Representing Manufacturing in meetings to ensure end-user requirements are captured.

• Supporting process technology transfer and preparing manufacturing documentation for development, engineering, and PPQ batches.

• Identifying and executing process improvement projects for new product introduction.

• Collaborating with sustaining teams to address current issues and ensuring the impact of new products is defined, agreed upon, and understood.

• Writing process impact assessments to support new product introduction.

• Providing SME input into cross-functional teams investigating and optimizing new manufacturing processes, procedures, and documentation.

• Delivering training on new procedures to Business Process Analysts (BPAs).

• Supporting external and internal audits.

• Collaborating with cross-functional teams on the introduction of consumables and raw materials for new product introduction.

• Promoting a “Right-First-Time Culture” and providing leadership in the use of Operational Excellence principles.

• Supporting the disposition process when required.

• Managing organizational activities such as purchasing and coordinating communication information.

• Driving change controls, CAPAs, investigations, improvement projects, and operational safety initiatives.

• Minimizing human error and collaborating with operations to address error sources.

• Approving operations procedures, electronic batch records, and other GMP documentation while providing technical training and knowledge transfer to the Operations team.

• Supporting sustaining operations when required to ensure product supply.

• Developing strong working relationships with Quality, Engineering, Technical Services, Supply Chain, Regulatory Affairs, Human Resources, and Finance.

• Supporting and implementing new technology solutions, such as Single-Use technology.

Qualifications and Experience

• Proven ability to communicate and collaborate across various levels, coupled with excellent organizational and planning skills. Must demonstrate success working in a team environment, as well as strong leadership and influencing skills, with flexibility to adapt to changing business needs.

• Strong problem-solving and project management abilities, as well as experience with lean manufacturing.

• Currently completing a Bachelor’s or Master’s degree in Science, Engineering, or a related subject.

• In-depth theoretical knowledge of GMP biologics manufacturing equipment and process automation.

• Proven ability to close out complex technical investigations.

• Strong working knowledge of systems such as Delta V, MES Syncade, and SAP.

• Excellent presentation skills.

Key Competencies
Candidates must demonstrate behaviors aligned with operational excellence, adaptability, and innovation in the biopharma manufacturing space.