Project Engineer

Novozen Healthcare LLC; Massachusetts; On-site; USD 80,000 - 100,000; Full time

Job summary

Novozen Healthcare LLC is seeking a Project/Site Engineer in Massachusetts specializing in GMP pharma/biotech. The candidate will provide engineering support for manufacturing systems and compliance activities related to GMP documentation.

Ideal applicants should have a Bachelor's degree in Engineering, 4+ years of relevant experience, and familiarity with CQV documentation. Experience with BMS, EMS, and SCADA systems is preferred. The role offers a chance to work in a dynamic, regulated environment.

Qualifications

• 4+ years of GMP pharma/biotech manufacturing experience.
• Experience with CQV documentation and change controls.
• Knowledge of BMS, EMS, SCADA, and CMMS systems.

Responsibilities

• Provide engineering support for GMP manufacturing, facilities, and utilities.
• Support change controls, deviations, CAPAs, and GMP documentation.
• Assist with CQV activities including FAT/SAT, IQ/OQ/PQ.

Skills

GMP documentation

Engineering support

Change controls

CQV documentation

Troubleshooting

Education

Bachelor’s degree in Engineering or related field

Tools

BMS

EMS

SCADA

CMMS

Job description

Job Title: Project/Site Engineer — GxP Manufacturing

Employment Type: W2/1099

Duration: 1 Year

Job Summary:

We’re seeking a Project/Site Engineer with GMP pharma/biotech experience to support manufacturing systems, CQV activities, change controls, deviations/CAPAs, and GMP documentation in a regulated environment. Experience with BMS, EMS, SCADA, and validation activities preferred.

Responsibilities

• Provide engineering support for GMP manufacturing, facilities, and utilities
• Support change controls, deviations, CAPAs, and GMP documentation
• Assist with CQV activities including FAT/SAT, IQ/OQ/PQ
• Review P&IDs, specifications, redlines, and engineering documents
• Support audit readiness and regulatory inspections
• Troubleshoot manufacturing systems and equipment
• Coordinate with vendors, contractors, and internal teams

Requirements

• Bachelor’s degree in Engineering or related field
• 4+ years of GMP pharma/biotech manufacturing experience
• Experience with CQV documentation and change controls
• Knowledge of BMS, EMS, SCADA, and CMMS systems
• Familiarity with ISO cleanroom environments
• Strong GMP documentation and compliance experience

Preferred

• Cell & Gene Therapy or aseptic manufacturing experience
• Experience with Kneat, ValGenesis, GAMP, or 21 CFR Part 11