The OpportunityThe
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. The key responsibilities are:
- 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.
Who you are:- 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.
Knowledge, Skills, and Abilities- 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 detailed-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 job posting.
The expected salary range for this position based on the primary location for this position of 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. This position also qualifies for the benefits detailed at the link provided below.
This position also qualifies for the benefits detailed at the link provided below.
Benefits
