Purpose: Manages process development, scale up and technology transfer of liquid and solid products Provides engineering and technical operations oversight for various batch processes and equipment staging in the pharmaceutical industry. Provides expertise in engineering requirements for pharmaceutical facilities, equipment and development of new processes. Supervises and trains others
- Leads the manufacturing scale up of development batches, conduct technology transfer of new products in manufacturing facility.
- Writes, reviews and authorizes GMP critical documentation such as IQ, OQ, PQ, validation protocols and equipment specifications.
- Defines and documents the facilities, equipment, and tooling requirements for all new and existing products.
- Manages, designs and develops new methods and processes to improve productivity and reduce costs by improving integration of people, materials, and equipment.
- Serves as primary technical resource for assigned manufacturing processes, equipment, and tooling.
- Leads large engineering projects by completing multiple tasks.
- Examines issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve it at root cause.
- Completes routine process engineering reports, studies and calculations.
- Evaluates, procures, oversees installation, validates, optimizes and trains on new packaging and production equipment.
- Performs machine modifications, adjustments and minor repairs
- Collaborates in cross-functional teams
- Demonstrates flexibility, i.e. willingly takes on new tasks.
- Prioritizes projects and meets deadlines
- Clearly and accurately communicates with all levels of employees
Knowledge, Skills & Abilities:
- Thorough knowledge of manufacturing methods and processes, including flow, layout, and assembly and production equipment.
- Experience and knowledge of complex machines such as automated bottle filling equipment, building automation equipment, air handling systems and water purification equipment.
- Thorough knowledge of cGMP and manufacturing quality tools.
- Strong management skills, including planning and organization, decision making, problem solving, and project management.
- Strong knowledge of Microsoft office and other computer programs, including CAD software.
Education and Experience
- Bachelor's in Engineering (Chemical or Mechanical)
- 5 years’ experience in cGMP process environment,
- Prefer 5 years Pharmaceutical experience
- Minimum 3 years supervisory experience and increasing responsibility.