Senior Process Engineer – cGMP, 3-Shift Lead

Renaissance-Lakewood,-LL; Lakewood Township (NJ); In loco; USD 125.000 - 131.000; Tempo pieno

Descrizione del lavoro

Renaissance-Lakewood,-LL in New Jersey seeks a Process Engineer to define cGMP equipment, review designs, and manage projects from requirements through validation. You will troubleshoot filling/packaging lines, improve processes, ensure uptime, and support QA/Validation with documentation and change control. A B.S.

in Mechanical/Chemical/Biochemical Eng. and 3+ years pharma experience are preferred. Overnight/3-shift support may apply.

Competenze

• 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.

Mansioni

• Define and specify cGMP process equipment, piping and controls for product quality.
• 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 to prevent downtime.
• Develop and improve processes for control and troubleshooting.
• Ensure equipment uptime and meet objectives for filling/packaging lines.
• Lead changes to correct issues and prevent downtime.
• Serve as the technical expert for filling or packaging areas.
• Maintain reliable and safe manufacturing systems, improving rates and yields.
• Coordinate engineering trials and prepare reports.
• Prepare project documents: scopes, designs, budgets, piping diagrams, etc.
• Support QA/Validation with design documents and protocols.
• Assist change control, deviation management, CAPA resolution.
• Help with investigations of process equipment, utilities, and safety incidents.
• Implement preventive actions for equipment and processes.
• Write/modify procedures for operation of equipment.
• Propose operational efficiency improvements using Lean.
• Assess safety requirements and integrate into processes.
• Support purchasing of new manufacturing tech and equipment.
• Ensure projects are completed on time and budgets followed.
• Assist with training operations and maintenance personnel.
• Potentially supervise contractors and maintenance staff.

Conoscenze

cGMP knowledge

Documentation proficiency

Clean room design

Formazione

B.S. in Mechanical Engineering or Chemical Engineering or Biochemical Engineering

Strumenti

MS Project

Descrizione del lavoro

Renaissance-Lakewood,-LL in New Jersey seeks a Process Engineer to define cGMP equipment, review designs, and manage projects from requirements through validation. You will troubleshoot filling/packaging lines, improve processes, ensure uptime, and support QA/Validation with documentation and change control. A B.S.

in Mechanical/Chemical/Biochemical Eng. and 3+ years pharma experience are preferred. Overnight/3-shift support may apply.