Manufacturing Technical Associate

About the role

A healthier future drives us to innovate, advance science, and ensure healthcare access for generations. The Manufacturing Technical Associate is a pivotal role responsible for leading and facilitating cross-functional, manufacturing-led project teams while maintaining comprehensive oversight of the GMP environment across the OCN Production Site.

This role develops, coordinates, and manages end-to-end programs and processes within the Manufacturing Value Streams to ensure planned, predictable, and fully GMP-compliant production operations. Acting as a single point of contact for the manufacturing function, the Associate coordinates extensively with cross-functional site teams—including Site Operations, Maintenance, Engineering, and Quality Assurance—to manage facility maintenance, construction projects, and vendor-performed preventative maintenance.

Responsibilities

• Project & Asset Management – Deliver manufacturing projects on time and within budget while overseeing equipment lifecycles, procurement of routine replacement parts, preventative maintenance, and cross-functional optimization of technical and procedural deficiencies.
• Cleanroom Environment & Contamination Control – Drive continuous improvement of GMP cleaning programs through rigorous audits, vendor performance management, KPI monitoring, and proactive collaboration on contamination risk mitigation across manufacturing cleanrooms.
• Vendor & Customer Relationship Management – Serve as the primary liaison between Manufacturing and Facilities Management, acting as a single point of contact for work orders, contracts, purchasing, and preventative maintenance across all OCN GMP areas.
• EHS & Safety Leadership – Champion workplace safety by managing incidents and investigations, sponsoring the Manufacturing Safety Team, partnering with SHE teams on compliance, and cultivating a continuous improvement safety culture.
• Quality & Compliance – Investigate technical issues, review and approve manufacturing documentation, oversee microbiological controls, manage adverse environmental trends and CAPAs, and ensure audit readiness across all GMP operations.

Requirements

You possess a Bachelor’s degree in Microbiology, Life Sciences, applicable Engineering, or a related field with 3+ years of related experience or 5+ years of experience in a GMP Manufacturing environment with significant, demonstrated project management experience.

Skills

• Regulatory Knowledge: Thorough understanding of cGMP regulations and safe work practices within a biopharmaceutical manufacturing environment.
• Systems Proficiency: Hands-on experience with Veeva systems (including ownership of Planned Events and Quality Event Management for quality/safety CAPAs). Working knowledge of SAP, Excel, and Quality Management Systems (QMS).
• Relationship Management: Proven ability to build deep, productive, cross-functional partnerships, with a preference for prior experience managing vendors and Service Level Agreements (SLAs).
• Communication: Exceptional technical writing, presentation, and verbal communication skills, including the ability to author technical reports and revise standard operating procedures.
• Soft Skills: Highly detail-oriented with meticulous record-keeping skills; thrives in ambiguous, fast-paced, and rapidly changing business environments.

Work Environment & Physical Demands

• Ability to work extensive hours while standing, sitting, or bending as operationally required.
• Comfort working with or around hazardous chemicals (acids/bases), solvents, pressurized systems, compressed gases, and biological materials (Recombinant DNA).

Relocation benefits are not available for this role.

Pay

The expected salary range for this position in Oceanside, CA is $79,000.00 - $146,600.00 USD Annual. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

Benefits

This position qualifies for the benefits detailed at the provided link.