What are the responsibilities and job description for the Process Engineer – Biopharma Automation & Equipment Validation position at JMD Technologies Inc.?
Title: Process Engineer – Biopharma Automation & Equipment Validation
Location: Providence, RI (Onsite 5 days/week)
Employment Type: Contract
Status: Accepting Candidates
About the Role
Join a high-impact engineering team supporting the automation and optimization of manufacturing systems for advanced biopharmaceutical production. This role focuses on process equipment, automation, validation, and technology transfer within a cGMP-regulated manufacturing environment.
Key Responsibilities
- Lead process equipment development, specification, commissioning, qualification, and lifecycle support.
- Drive equipment validation, FAT/SAT, risk assessments, and technology transfer activities.
- Troubleshoot manufacturing equipment and implement process improvements to enhance reliability and efficiency.
- Author and review URS, protocols, reports, SOPs, and engineering documentation.
- Support deviations, CAPA, change control, and root cause investigations.
- Collaborate with Manufacturing, Quality, Validation, MSAT, Facilities, and external vendors.
Qualifications
- BS/MS in Engineering or a related technical discipline.
- 5–7 years of Process Engineering, Equipment Engineering, or Manufacturing Systems experience in a cGMP environment.
- Hands-on experience with equipment commissioning, qualification, validation, FAT/SAT, and URS development.
- Strong knowledge of cGMP, 21 CFR Part 210/211, FMEA, CAPA, and Change Control.
- Experience supporting biopharmaceutical, cell & gene therapy, or related GMP manufacturing processes.
- Proven experience working with cross-functional teams and equipment vendors.