Senior Process Engineer - Pharma CGMP & Packaging

Renaissance Lakewood LLC; Lakewood Township (NJ); On-site; USD 125,000 - 131,000; Full time

Job summary

Renaissance Lakewood LLC is seeking a qualified Process Engineer to define cGMP equipment and controls, manage projects from design through validation, and ensure uptime on filling/packaging lines. You will assist with design reviews, site installations, and troubleshooting to prevent downtime, while improving manufacturing efficiency.

A BS in a related engineering field and pharma experience are required. Role may require off-shift work to support a 3-shift operation, with MS Project for

Qualifications

• B.S. degree in Mechanical, Chemical, or Biochemical Engineering is required.
• Three years of relevant pharmaceutical industry experience preferred.
• Thorough knowledge of cGMPs and sanitary equipment design requirements.
• Advanced knowledge of engineering documentation for cGMP process equipment.
• Substantial knowledge of clean room design and function.

Responsibilities

• Define and specify cGMP process equipment, piping and controls for product creation.
• Assist in design review, site acceptance and installation of equipment.
• Manage small to medium projects from requirements to validation.
• Create detailed project plans and schedules using MS Project.
• Troubleshoot filling and packaging equipment and prevent downtime.
• Develop and improve processes for control and troubleshooting of manufacturing problems.
• Ensure equipment uptime and meet objectives for filling and packaging lines.
• Troubleshoot line issues and lead changes to prevent downtime.
• Serve as the technical expert for filling or packaging area.
• Maintain safe manufacturing systems while improving rates, yields, and changeovers.
• Coordinate engineering trials and present findings.
• Prepare project documents including scopes, specs, P&IDs, and cost estimates.
• Support QA and Validation with design documents and protocols.
• Support compliance activities and CAPA resolution.
• Assist investigations of process equipment and safety incidents.
• Implement preventive actions for equipment and processes.
• Write/modify procedures for operation of equipment.
• Propose efficiency improvements for production lines using Lean.
• Assess safety requirements and integrate them into processes.
• Assist in researching and purchasing new manufacturing technology.
• Ensure projects are completed on time and budgets followed.
• Assist training of operations and maintenance personnel.
• May supervise contractors and technical staff.

Skills

cGMP knowledge

Sanitary equipment design

Engineering documentation

Lean principles

Project management

Education

Bachelor's degree in Mechanical, Chemical, or Biochemical Engineering

Tools

MS Project

Job description

Renaissance Lakewood LLC is seeking a qualified Process Engineer to define cGMP equipment and controls, manage projects from design through validation, and ensure uptime on filling/packaging lines. You will assist with design reviews, site installations, and troubleshooting to prevent downtime, while improving manufacturing efficiency.

A BS in a related engineering field and pharma experience are required. Role may require off-shift work to support a 3-shift operation, with MS Project for