Manufacturing Process Engineer II

2 weeks ago

Lakewood, New Jersey, United States Renaissance LLC Full time
Renaissance LLC

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Manufacturing Process Engineer II

Job ID:
Type: Regular Full-Time
# of Openings: 1
Category: Engineering/Facilities

Overview

The role involves assessing current operational procedures and optimizing manufacturing machinery and systems to enhance cost-efficiency, promote sustainability, and establish best practices in production by utilizing principles of systems engineering alongside the disciplines of chemistry, physics, and equipment engineering.



Responsibilities

Candidates should possess 3 to 5 years of experience in designing processes and machinery for pharmaceutical production, with a preference for those familiar with aseptic filling. The position entails ensuring the reliability of automated manufacturing lines and assisting in troubleshooting equipment challenges in a dynamic environment.

Key duties include:

  • Defining and specifying cGMP process machinery, piping, and controls to enhance process capability and production volume while upholding quality standards.
  • Participating in design reviews, site acceptance tests, and equipment installations.
  • Troubleshooting filling and packaging machinery and devising solutions to minimize downtime.
  • Enhancing existing processes and methodologies for managing and resolving manufacturing technical issues.
  • Ensuring machinery uptime through prompt and effective resolution of production equipment challenges to meet objectives for filling and packaging lines.
  • Addressing filling and packaging line challenges related to equipment, personnel, materials, and quality, leading the implementation of corrective actions to prevent downtime.
  • Serving as the technical authority for the designated area in filling or packaging.
  • Maintaining reliable and safe manufacturing systems while improving production rates, efficiencies, yields, costs, and changeovers.
  • Flexibility to work on off-shifts to support a three-shift operation.
  • Coordinating and conducting engineering trials, followed by preparing reports and presenting findings.
  • Drafting documents to support projects, including project scopes, conceptual design presentations, capital requests, specifications, piping and instrumentation diagrams, process flow diagrams, schedules, requests for quotations, project expenditures, project procedures, correspondence, start-up procedures, and cost estimates.
  • Assisting QA and Validation departments by preparing design documents and aiding in protocol development and execution.
  • Participating in investigations of process equipment, utility systems, and control anomalies, as well as safety incidents.
  • Implementing corrective and preventive actions for existing equipment and manufacturing processes.
  • Preparing change control documentation.
  • Writing and revising procedures for the proper operation of new and/or existing equipment.
  • Proposing and executing operational efficiency enhancements for production lines utilizing Lean principles.
  • Assessing safety requirements and ensuring their integration into the process.
  • Supporting the Senior Manager in researching and procuring new manufacturing technologies and equipment.
  • Ensuring timely project completion and adherence to financial budgets.
  • Assisting in the training of operations and maintenance personnel as necessary.
  • Potentially supervising mechanical, electrical, and automation contractors, as well as maintenance mechanics, contract engineers, and construction contractors.
  • Performing other duties and responsibilities as assigned.


Qualifications

A Bachelor’s degree in Chemical, Biochemical, Equipment, or Mechanical Engineering is required. A minimum of three years of relevant experience in the pharmaceutical sector is preferred.



Compensation details: 0 Yearly Salary

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