Senior Aseptic Fill-Finish Process Engineer

BioSpace

San Diego (CA)

On-site

USD 130,000 - 180,000

Full time

14 days+

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Benefits offered by this job

Remote work options

Job summary

Syner-G in San Diego, CA is seeking a Sr. Fill-finish Process Engineer with strong aseptic manufacturing experience to support the buildout of a new fill-finish suite within a commercial facility.

You will collaborate across operations, QA, validation, MS&T, and engineering to ensure compliant, high-performance manufacturing. The ideal candidate has hands-on expertise in formulation, sterile filtration, aseptic filling, lyophilization, capping, inspection, and related equipment, with a solid GMP

Qualifications

Bachelor’s or Master’s degree in Chemical, Mechanical, Biomedical, Pharmaceutical Engineering or related field.
7+ years of GMP pharmaceutical/biotech manufacturing experience.
Experience with sterile, aseptic, biologics, or vaccine fill-finish operations.

Responsibilities

Support design, construction, installation, and qualification of new fill-finish suite.
Prepare equipment specifications, review design and vendor evaluations.
Lead FAT/SAT, commissioning, and qualification activities for fill-finish equipment.
Maintain alignment with GMP requirements and regulatory guidelines.

Skills

Aseptic operations

Cleanroom operations

Process engineering

Documentation

Communication

Education

Bachelor’s or Master’s degree in Chemical/Mechanical/Biomedical/Pharmaceutical Engineering

Tools

KNEAT

Process control systems

Job description

Syner-G in San Diego, CA is seeking a Sr. Fill-finish Process Engineer with strong aseptic manufacturing experience to support the buildout of a new fill-finish suite within a commercial facility.

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