Senior Aseptic Fill-Finish Process Engineer (Remote)

Syner-G BioPharma Group

Boston (MA)

Hybrid

USD 120,000 - 180,000

Full time

2 days ago

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Benefits offered by this job

Flexible PTO

Company-paid holidays

Flexible working hours

Fully remote options

Office locations

Job summary

Syner-G BioPharma Group is seeking a Sr. Fill–Finish Process Engineer to lead aseptic manufacturing initiatives for a new fill–finish suite in a commercial facility. The role partners with operations, QA, validation, MS&T, and engineering to ensure compliant, high-performing processes.

The ideal candidate brings hands-on experience in formulation, sterile filtration, lyophilization, capping, inspection, and regulatory expectations, with strong GMP knowledge and project leadership abilities.

Qualifications

Bachelor’s or Master’s degree in Chemical, Mechanical, Biomedical, Pharmaceutical Engineering or a related technical field.
Typically 7+ years of GMP pharmaceutical or biotech manufacturing experience.
Experience with commissioning, qualification and engineering documentation.

Responsibilities

Support design, construction, installation, and qualification of a new commercial fill–finish suite.
Contribute to user requirement development, equipment specifications, vendor evaluations, and design reviews.
Support FAT/SAT, commissioning, and qualification activities for fillers, isolators or RABS, lyophilizers, depyrogenation tunnels, autoclaves, CIP/SIP systems, formulation vessels, sterile filtration skids, and inspection machines.
Coordinate across engineering, operations, facilities, quality, and validation to ensure successful project execution.