Sr. Process Engineering Manager

The Manager of Process Engineering will be responsible for the leadership of the Process Engineering team at the Rancho Dominguez, CA facility. They will provide technical leadership to the site and work to deliver projects alongside the global engineering network. The candidate will have extensive work experience with bio/pharma manufacturing systems, process control, change management, equipment design, safety, and qualification activities. The ideal candidate should have relevant experience in a GMP or ISO9001 manufacturing environment and thrive in an agile and collaborative culture. A team player with strong communication skills will succeed in this role.

·         Develop and manage a Process Engineering team which is responsible for project execution, manufacturing support, and tech transfer focused on TFF filtration and single use flow path products.

·         Provide leadership and coaching in the areas of TFF filtration, equipment design and qualification, tech transfer, project management, and facility design.

·         Set strategic and technical goals for the engineering team to promote continuous improvement and project delivery.

·         Act as a cross-functional site lead with peers in Manufacturing, Facilities, Quality Assurance, and related groups to provide a safe and compliant facility.

·         Serve as the site lead for Engineering during client audits and regulatory inspections.

·         Communicate with a global engineering network to advance strategic project initiatives in support of ongoing corporate growth.

·         Identify and drive continuous improvement efforts, industry standards, regulatory compliance, and efficiency.

·         Manage, approve, and generate engineering documentation including test protocols, change controls, action plans, and reports.

·         Scheduling, advising activities, budgeting, and hiring for the department.

·         Responsible for the implementation of new products and associated manufacturing processes.

·         Provide significant mentoring to junior staff members and support for establishing standards and training for best practices in process development.

·         Utilize statistical methods to support engineering tests and process validations.

·         This is an on-site role.

·         BS in Mechanical/Biomedical/Industrial Engineering is required with 10+ years or equivalent experience in engineering in a life science, pharmaceutical, medical device, and/or biologics setting required.

·         Demonstrated strong management and leadership skills in developing talent and implementing program strategies.

·         Independent problem solving and the ability to drive a team to support an ongoing ISO-9001 regulated operation.

·         Experience working with cross-functional groups and managing projects through a matrix of resources to complete.

·         Thorough understanding of lean principles and manufacturing processes is required.

·         Working knowledge of single-use products and sterilization processes is desired.

·         Biopharmaceutical and/or Medical Device development experience is desired.

·         Must lead by example and possess a high sense of personal integrity and accountability.

·         Must possess high bandwidth and be able to fill multiple roles, as needed.

·         Must be proficient with SolidWorks/CAD, MS Office, and electronic file management.