Job Description
Description:
Manufacturing Operations Execute and monitor aseptic fill/finish activities including pooling/mixing, filtration, vial/syringe filling, capping, visual inspection, labeling, and packaging in full compliance with cGMP. Operate, monitor, and troubleshoot automated and semi-automated filling, inspection, labeling, packaging and serialization equipment. Perform sterile gowning and work effectively in Grade A/B/C/D cleanroom environments. Conduct in-process sampling, support environmental monitoring, and perform real-time quality checks. Execute in-process checks, environmental and system monitoring, and alarm/exception response according to validated procedures. Troubleshoot system faults and escalate mechanical, software, or sterility-related issues when required. Perform manual and semi-automated visual inspection of sterile drug products to detect particulates, cosmetic defects, and container-closure abnormalities. Maintain visual inspection proficiency by completing required annual operator qualification assessments. Undergo and maintain compliance with the annual eye examination requirement to ensure visual acuity necessary for inspection tasks. Support upkeep of defect libraries, inspector training files, and trending of reject categories. Escalate atypical findings and actively contribute to root cause investigations for inspection-related deviations. Set-up, prepare, and operate manufacturing equipment/assemblies (includes freeze/thaw equipment, filtration assemblies, drug product fill equipment, filter integrity tester, environmental monitoring system, visual inspection booth, labeling machine, packaging machine) in accordance with current good manufacturing practices (cGMP). Perform clinical and commercial labeling, packaging, and serialization activities in accordance with the manufacturing order. Equipment, Facilities, and Readiness Perform equipment changeover, cleaning, sanitization, and routine maintenance. Support basic equipment troubleshooting and coordinate with internal teams or vendors as needed. Maintain cleanroom readiness, including room sanitization and equipment status verification. Set up, operate, and maintain manufacturing equipment (e.g., freeze/thaw systems, filtration assemblies, filling equipment, filter integrity testers, visual inspection booths). Process & Documentation Support development and refinement of Fill/Finish processes and Bills of Materials. Participate in tech transfer, engineering runs, qualification, and validation activities. Accurately complete batch records, logbooks, and electronic documentation in compliance with GDP. Create and revise SOPs, batch records, specifications, bill of materials, and other GMP documents. Quality Systems & Continuous Improvement Participate in deviations, CAPAs, root cause investigations, change controls, and other quality system activities. Identify process and equipment improvement opportunities; contribute to LEAN, 5S, and Six Sigma initiatives. Provide hands-on and classroom training to team members. Safety Follow all safety procedures, including proper handling of biologics, cleaning agents, and raw materials. Escalate safety concerns and support safety audits and required training. Requirements:
QUALIFICATIONS - SKILLS & REQUIREMENTS
Background in Biological or Chemical Sciences. Proficiency with Microsoft Office; experience with SAP or similar ERP is a plus Comprehensive understanding of aseptic techniques, media fill qualifications, and contamination control strategies. Basic proficiency in equipment control and automation processes Strong organizational and record-keeping skills. Ability to work independently, collaborate within teams, or lead assigned tasks. Effective verbal and written communication skills. Ability to lift = 50 lbs, work in hot/cold or wet environments, and perform repetitive motions. Color differentiation and clear visual acuity required for inspection tasks. Ability to work with and around large equipment Ability to lead small operational teams or initiatives. Knowledge of cGMP's. EDUCATION & EXPERIENCE
Associate-level coursework (2 years science-focused) in Cell Biology, Biochemistry, Chemistry, or a related field plus 2-4 years of relevant experience, OR 4-8 years of directly related industry experience and/or training, or equivalent combination of education and experience WORK ENVIRONMENT
This is a Manufacturing position, located in our manufacturing facility in Emeryville, CA. The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the individual is: Must possess visual acuity adequate to identify small defects under controlled lighting conditions. Near vision and color perception sufficient to distinguish particulate matter and cosmetic defects in transparent and amber containers. Ability to maintain sustained visual concentration during repetitive inspection activities. Corrective lenses are permitted if vision is corrected to satisfactorily perform inspection duties. Moderate noise (i.e., background noise due to computers, phone, printers, and light hallway traffic). Constantly required to use hands and fingers to operate office machines and equipment. Frequently required to reach with hands and arms. Occasionally required to stoop, kneel, and crouch. Able to work a flexible schedule as needed. Accessibility via Cell Phone Work a nonstandard schedule. Work evening or night shift hours. Provide coverage for other positions, shifts, or functions. Frequently required to sit and/or stand, walk, talk, and hear. Ability to sit at a computer for an extended period of time
