GMP Process Engineer – Pharma/Biotech Manufacturing

Trinity Consultants - Advent Engineering; Wilson (NC); On-site; USD 110,000 - 170,000; Full time

Job summary

ADVENT Engineering is seeking experienced Process Engineers to support capital projects, facility start-up, equipment installations, commissioning, lifecycle documentation, and engineering deliverables within GMP-regulated pharmaceutical and biotechnology environments. This role will support design and start-up of cGMP large molecule manufacturing.

The ideal candidate will have strong experience in engineering support, process technology, and provide technical leadership for schedule reviews,

Qualifications

• Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical, or related discipline) required.
• Minimum of 4+ years of experience within pharmaceutical, biotechnology, or other regulated manufacturing environments.
• Experience supporting site engineering, facilities engineering, process engineering, CQV, or validation activities in GMP environments required.
• Experience with manufacturing equipment, clean utilities, facility systems, and startup/qualification activities strongly preferred.

Responsibilities

• Create engineering design packages in compliance with regulatory requirements.
• Develop, review, and update technical specifications for equipment and facility systems.
• Provide engineering oversight during design, fabrication, installation, startup, and commissioning activities.
• Coordinate activities with vendors, contractors, architects, engineers, and internal stakeholders.
• Author, execute, review, and manage change controls in accordance with GMP and quality requirements.

Skills

Process engineering

GMP knowledge

Leadership

Technical writing

Cross-functional collaboration

Education

Bachelor’s degree in Engineering

Tools

CMMS

BMS

SCADA

Job description

ADVENT Engineering is seeking experienced Process Engineers to support capital projects, facility start-up, equipment installations, commissioning, lifecycle documentation, and engineering deliverables within GMP-regulated pharmaceutical and biotechnology environments. This role will support design and start-up of cGMP large molecule manufacturing.

The ideal candidate will have strong experience in engineering support, process technology, and provide technical leadership for schedule reviews,