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Renaissance Lakewood, LLC · 1 week ago
Sr. Process Engineer
Lakewood, NJ
Full-time
Onsite
Senior Level
$106K/yr - $125K/yr
5+ years exp
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Health CareManufacturing
Insider Connection @Renaissance Lakewood, LLC
Responsibilities
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.
Assist in the design review, site acceptance, and installation of equipment.
Troubleshoot filling and packaging equipment and provide solutions to prevent downtime.
Develop and improve existing processes and methods for control and troubleshooting of manufacturing technical problems.
Ensure equipment uptime through the expedient, effective resolutions of production equipment problems to meet objectives for filling and packaging lines.
Troubleshoot filling and packaging line issues related to equipment, people, materials, and quality. Lead implementation of changes to correct the issues and prevent downtime.
Serve as the technical expert for the assigned area in filling or packaging.
Maintain reliable and safe manufacturing systems while improving production rates, efficiencies, yields, costs, and changeovers.
Be flexible to work on off-shifts to support a 3 shifts operation.
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.
Perform other duties and responsibilities as assigned.
Qualification
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Required
B.S. degree in Chemical, Biochemical, Equipment, or Mechanical Engineering is required
5 plus years’ experience with designing processes and equipment for pharmaceutical manufacturing
Experience in aseptic filling is a plus
Thorough knowledge of cGMPs and sanitary equipment design requirements
Advanced knowledge of engineering documentation required for cGMP process equipment
Substantial knowledge of clean room design and function
Preferred
Three years of relevant experience in the pharmaceutical industry
Company
Renaissance Lakewood, LLC
Renaissance is a US-based contract development and manufacturing organization (CDMO) for pharmaceutical and biotech companies.
201-500 employees
H1B Sponsorship
Renaissance Lakewood, LLC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2022 (3)
2021 (4)
2020 (2)
Funding
Current Stage
Growth StageLeadership Team
Robert Harrer
Vice President and CFO
Alexis Savoth
Human Resources Business Partner
Company data provided by crunchbase
