Critical Systems Engineer
Responsible for evaluating existing processes and configuring manufacturing equipment and systems to reduce cost, improve sustainability, and develop best practices within the production process by applying systems engineering principles and technology of chemistry, physics, and equipment engineering.
- Define and specify cGMP process equipment, piping and controls related to the creation of products that improve process capability and production volume while maintaining and improving quality standards.
• Manage small-to-mid size projects related to process equipment and manufacturing.
• Assist in the design review, site acceptance and installation of equipment.
• Evaluate and improve on manufacturing processes.
• Maintain reliable and safe manufacturing systems while improving production rates, efficiencies, yields, costs and changeovers.
• Coordinate and perform engineering trials and then prepare reports and present on the findings.
• Prepare documents for support of projects including project scopes, presentation of conceptual designs, capital requests, specifications, piping and instrumentation diagrams, process flow diagrams, schedules, requests for quotations, project expenditures, project procedure, correspondence, start-up procedures and cost estimates.
• Support QA and Validation departments by preparation of design documents and assisting in protocol generation and execution.
• Assist in investigations or process equipment, utility systems, and control anomalies as well as safety incidents.
• Implements connective/preventive actions for existing equipment and manufacturing processes.
• Prepare change control documentation.
• Write and modify procedures for the proper operation of new and/or existing equipment.
• Propose and implement operational efficiency improvements for production lines utilizing Lean principles.
• Assess safety requirements and ensure that these are integrated into the process.
• Support Sr. Manager in research and purchase of new manufacturing technology and equipment
• Ensure projects are completed on time.
• Ensure financial budgets are followed.
• 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.
- B.S. degree in Chemical, Biochemical, Equipment, or Mechanical Engineering is required.
- 3+ years of relevant experience in the pharmaceutical industry is preferred.
- A thorough knowledge of cGMPs and sanitary equipment design requirements;
- Advanced knowledge of engineering documentation required for cGMP process equipment; and
- Substantial knowledge of clean room design and function