Senior Aseptic Fill-Finish Engineer | Remote Options

BioSpace; San Diego (CA); Vor Ort; USD 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Remote work options for most positions

Generous PTO and holidays

Career development opportunities

Zusammenfassung

Syner-G is seeking a Sr. Fill–Finish Process Engineer to lead aseptic pharmaceutical/biologics manufacturing initiatives for a new commercial fill–finish suite.

You will drive formulation, filtration, lyophilization, capping, inspection, and related equipment, collaborating with Operations, QA, Validation, MS&T, and Supply Chain to ensure GMP compliance and robust performance. The role requires strong technical writing, problem solving, and cross-functional communication, with travel to client

Qualifikationen

• Bachelor’s or Master’s degree in Chemical, Mechanical, Biomedical, Pharmaceutical Engineering or a related technical field.
• Typically 7+ years of experience in GMP pharmaceutical or biotech manufacturing.
• Strong preference for sterile, aseptic, biologics, or vaccine fill–finish experience.
• Experience supporting commercial manufacturing operations in a regulated environment.
• Experience with commissioning, qualification, and engineering documentation.

Aufgaben

• Support design, construction, installation, and qualification of a new commercial fill–finish suite, including cleanrooms, process utilities, and supporting infrastructure.
• 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.
• Generate and maintain engineering lifecycle documentation including URS/FRS documents, FAT/SAT packages, and turnover packages.

Kenntnisse

Aseptic operations

Fill–finish systems

GMP documentation

Process validation

Project coordination

Ausbildung

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

Tools

KNEAT

Jobbeschreibung

Syner-G is seeking a Sr. Fill–Finish Process Engineer to lead aseptic pharmaceutical/biologics manufacturing initiatives for a new commercial fill–finish suite.

You will drive formulation, filtration, lyophilization, capping, inspection, and related equipment, collaborating with Operations, QA, Validation, MS&T, and Supply Chain to ensure GMP compliance and robust performance. The role requires strong technical writing, problem solving, and cross-functional communication, with travel to client