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Job Description

General Summary:

The Facilities Engineering Manager will be supporting the newly developed function called the Advanced Manufacturing Engineering under the Global Engineering team. The position provides strategic partnerships with the CMC and CMSC teams to improve, optimize and launch new/existing products at internal and external manufacturing sites. The Advanced Manufacturing Engineering Manager will support multiple Internal and External capital projects.

This role will involve in various aspects of manufacturing, equipment, facility and infrastructure-focused engineering efforts for existing and new facilities, from conceptual to detailed design, procurement, startup, testing, and commissioning for on-going outsourced and insourced manufacturing operations.

Key Duties and Responsibilities:

• Work with the Advanced Manufacturing Engineering team on capital project execution, schedule, and budget.
• Partner with internal and external teams to scale and improve existing products and transfer new products into manufacturing from facilities, equipment and utilities standpoint.
• Provide strategic feedback for insourced and outsourced manufacturing function by defining strategy and roadmap for investment in people, process, equipment and facilities to scalable support rapid business growth for all modalities.
• Generate manufacturing operational model to ensure maximum throughput, optimized equipment layout and material balance within internal assets and provide feedback to external assets.
• Strategic partner for procurement of manufacturing equipment from URS to release for GMP use.
• Periodic review of the manufacturing assets to ensure optimization and cost reduction.
• Work closely to the Quality team to ensure compliance during in house and external GMP manufacturing including strategies to successfully implement manufacturing or quality control method changes.
• Lead science-centric strategic decisions for capital projects based on scientific knowledge, education and level of experience.
• Facilitate and perform design reviews for various capital projects with awareness of cost, efficiency, and compliance.
• Cultivate change and innovation by seeking opportunities to strengthen and improve existing engineering services.

Knowledge and Skills:

• Candidate must be responsive to change and adapt quickly to changing circumstances.
• Must demonstrate effective self-management and act on improvement opportunities.
• Developed verbal and written communication skills and interpersonal skills to explain complex.
• information to others in straightforward situations
• Ability to navigate and be successful in a fast-paced, highly matrixed work environment.
• Knowledge of current applicable regulatory expectations
• Experience supporting Research and Development in the Pharmaceutical, Biopharmaceutical or other regulated industry.
• Knowledge of cGMP and regulated facility design, change control processes, compliance requirements, commissioning, qualification, validation, and best practices in the pharmaceutical industry.

Education and Experience:

• Bachelor's degree in Chemical Engineering, or a related discipline
• Master's degree in Engineering or related discipline preferred but not required
• Typically requires 6+ years of relevant work experience in manufacturing engineering; OR, any equivalent combination of experience and/or education from which comparable knowledge, skills, and abilities have been achieved

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