Critical Systems Engineer
Company: Job Juncture
Posted on: November 22, 2022
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
• Manage small-to-mid size projects related to process equipment
• Assist in the design review, site acceptance and installation of
• 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
• 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
• May supervise mechanical, electrical and automation contractors
as well as Maintenance mechanics, Contract Engineers and
- B.S. degree in Chemical, Biochemical, Equipment, or Mechanical
Engineering is required.
- 3+ years of relevant experience in the pharmaceutical industry
- A thorough knowledge of cGMPs and sanitary equipment design
- Advanced knowledge of engineering documentation required for
cGMP process equipment; and
- Substantial knowledge of clean room design and function
Keywords: Job Juncture, Brick , Critical Systems Engineer, Other , Jackson, New Jersey
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