Evaluate existing processes and configure manufacturing equipment to reduce costs and improve sustainability.
Define and specify cGMP process equipment, piping, and controls to enhance process capability and production volume while maintaining quality standards.
Assist in the design review, site acceptance, and installation of equipment.
Troubleshooting and Maintenance:
Ensure overall reliability of automated manufacturing lines and troubleshoot equipment issues in a fast-paced environment.
Develop solutions to prevent downtime for filling and packaging lines and lead implementation of changes.
Process Improvement:
Develop and improve existing processes and methods for control and troubleshooting of manufacturing technical problems.
Propose and implement operational efficiency improvements utilizing Lean principles.
Conduct engineering trials, prepare reports, and present findings.
Documentation and Compliance:
Prepare project documents including scopes, conceptual designs, capital requests, specifications, P&IDs, schedules, RFQs, expenditures, procedures, and cost estimates.
Support QA and Validation departments by preparing design documents and assisting in protocol generation and execution.
Prepare change control documentation and write/modify procedures for proper operation of new/existing equipment.
Ensure safety requirements are integrated into the processes.
Project and Personnel Management:
Support Sr. Manager in research and purchase of new manufacturing technology and equipment.
Ensure projects are completed on time and within financial budgets.
Assist with training of operations and maintenance personnel as needed.
May supervise mechanical, electrical, and automation contractors as well as maintenance mechanics, contract engineers, and construction contractors.
Experience Requirements:
General:
3 to 5 years of experience in designing processes and equipment for pharmaceutical manufacturing.
Experience with aseptic filling is a plus.
Technical:
Proven ability to troubleshoot filling and packaging line issues related to equipment, materials, and quality.
Experience in improving production rates, efficiencies, yields, costs, and changeovers.
Ability to work on off-shifts to support a 3-shift operation.
Educational Requirements:
B.S. degree in Chemical, Biochemical, Equipment, or Mechanical Engineering is required.
Three years of relevant experience in the pharmaceutical industry is preferred.
This role demands a blend of engineering expertise, hands-on problem-solving skills, and a solid understanding of pharmaceutical manufacturing processes, especially in ensuring equipment reliability and optimizing production efficiency. The ideal candidate will have a strong background in cGMP, lean principles, and the ability to manage complex projects and troubleshoot technical issues effectively.