Senior Aseptic Processing Specialist

Senior Aseptic Processing Specialist

Location: Vacaville, CA (Onsite)

Reports to: Associate Director, Manufacturing

Job Type: Full-time

FLSA: Non- Exempt

Company Overview

Polaris Pharmaceuticals, part of Polaris Group, is a multinational biotechnology company focused on the discovery, development, and manufacturing of innovative therapies, with a primary focus on oncology. The company’s lead therapeutic candidate, pegargiminase (ADI-PEG 20), is currently in late-stage clinical development across multiple cancer indications.

Polaris operates across the full drug development lifecycle, from research and clinical development to cGMP manufacturing. With facilities in the United States and Asia, the company combines scientific innovation with integrated development and manufacturing capabilities to advance therapies for patients worldwide.

Job Summary

The Senior Aseptic Processing Specialist is responsible for the setup, maintenance, troubleshooting, and repair of aseptic fill/finish equipment, including Restricted Access Barrier Systems (RABS) and vial filling systems. This role serves as a key technical resource to ensure reliable, efficient, and compliant operation of drug product manufacturing processes in a cGMP cleanroom environment.

In addition to leading equipment-related activities, the individual will actively support aseptic processing operations, including media fills and GMP production runs. The role requires close collaboration with Manufacturing, Engineering, Facilities, and Quality teams to maintain production readiness, resolve issues, and drive continuous improvement initiatives.

The successful candidate will demonstrate strong hands-on technical expertise, the ability to independently diagnose and resolve equipment issues, and a high level of aseptic discipline while working in Grade A/B cleanroom environments.

Key Responsibilities

• Perform advanced troubleshooting, maintenance, and repair of aseptic fill/finish equipment, including RABS, isolators, and automated filling systems
• Independently diagnose equipment issues and implement corrective actions to minimize downtime and production impact
• Lead or support root cause investigations, CAPAs, and change controls related to equipment performance and manufacturing deviations
• Support aseptic manufacturing operations, including media fills, engineering runs, and GMP drug product filling
• Maintain and ensure compliance with aseptic gowning qualifications and contamination control procedures
• Collaborate with Engineering and Facilities to drive equipment improvements, reliability initiatives, and preventative maintenance programs
• Ensure adherence to cGMP and GDP requirements, including accurate documentation and record keeping
• Partner cross-functionally with Manufacturing, Quality, MSAT, and Facilities to support production scheduling and operational readiness
• Assist in equipment qualification, validation, and startup activities as needed

Required Qualifications

• High-school diploma or equivalent required.
• Knowledge of cGMP regulations and compliance requirements.
• Strong understanding of mechanical systems, pneumatics, servo motors, sensors and other automated-controlled equipment.
• Critical thinking skills, initiative, integrity, and possess the ability to perform responsibilities without supervision.
• Ability to work independently and prioritize multiple projects in a fast-paced environment.
• Strong written, verbal, and communication skills.
• Able to maintain aseptic qualifications.

Preferred Qualifications

• Minimum 3 years of experience working in a biological manufacturing environment, with focus on automated mechanical equipment.
• Certificate or degree in a mechanical, electro-mechanical or industrial maintenance preferred.
• Bachelor’s degree in a biological field, or equivalent.
• Technical knowledge of biopharmaceutical manufacturing, specifically in fill/finish.
• Proficient in Windows, Microsoft Office and other computerized applications.

Physical / Work Environment

• The work environment is inside a cleanroom laboratory with classifications up to Grade A/B.
• The mechanic will be required to perform tasks inside the area while maintaining an aseptic environment.
• The mechanic will be required to lift up to 50lbs.

Salary Range

• $35-$43/hour

Equal Employment Opportunity Statement

Polaris Pharmaceuticals is an Equal Opportunity Employer. We are committed to building a diverse and inclusive workplace and do not discriminate on the basis of race, color, religion, sex, gender identity or expression, sexual orientation, national origin, age, disability, veteran status, or any other protected characteristic under applicable federal, state, or local laws.