Manufacturing Visual Inspection

Manufacturing Visual Inspection Technician – 1st ShiftSigma Inc. is seeking a Manufacturing Visual Inspection Technician to support drug product manufacturing operations at a GMP-regulated pharmaceutical manufacturing facility in Fremont, CA.The ideal candidate will have at least 1 year of experience in a cGMP-regulated manufacturing environment and be comfortable performing detailed visual inspection, manufacturing operations, documentation, and computerized manufacturing processes. This role requires a strong quality-focused, right-first-time mindset and the ability to work effectively in a highly regulated production environment.Key ResponsibilitiesPerform routine manufacturing operations related to drug product visual inspection in a multi-product facility.Perform visual inspection and advanced visual inspection activities following established procedures.Support palletizing, cleaning, inspection hood preparation, and other manufacturing operations.Perform BioMES/MES operations and exception handling as trained.Support drug product filling and packaging operations as needed.Complete logistics coordination, batch records, equipment use logs, and work orders.Initiate and track work orders and support manufacturing projects.Create and maintain training kits and related documentation.Perform all work in accordance with cGMP and cGDP requirements.Report abnormalities, deviations, and quality concerns accurately and promptly.Maintain production areas according to established 5S standards.Support quality activities, investigations, corrective actions, and area walkthroughs.Maintain required training and, once qualified, assist with training other technicians and associates.Follow all site safety procedures and promptly escalate unsafe conditions or practices.Required QualificationsHigh school diploma or equivalent.Minimum 1 year of experience in a cGMP/GMP-regulated industry.Strong attention to detail and a Quality/Right-First-Time mindset.Ability to work effectively in a complex technical manufacturing environment.Strong written and verbal communication skills.Ability to use computer-based manufacturing systems and MES platforms.Ability to read and understand SOPs, work instructions, and manufacturing documentation.Ability to accurately document work in accordance with cGMP standards.Strong teamwork and collaboration skills.Ability to perform detailed visual inspection work for extended periods.Preferred QualificationsAssociate's or Bachelor's degree in Biotechnology, Life Sciences, Manufacturing, or a related field.Biotechnology vocational training.Pharmaceutical, biotech, or drug product manufacturing experience.Experience with visual inspection, aseptic manufacturing, filling, packaging, or production operations.Experience with MES/BioMES systems.Experience with batch records, deviations, investigations, and manufacturing documentation.Physical & Vision RequirementsMust be able to read and see clearly and perform detailed visual inspection activities.Candidates must successfully complete a vision test, including visual acuity and color blindness testing, before starting the assignment.Some physical effort may be required depending on manufacturing activities.Lifting requirements may vary, with typical lifting requirements of up to 25 pounds.Important RequirementA vision test, including visual acuity and color blindness testing, is required and must be successfully completed prior to starting the assignment.Ideal CandidateThis opportunity is well suited for candidates with titles such as:Manufacturing TechnicianManufacturing AssociateManufacturing OperatorVisual Inspection TechnicianPharmaceutical Manufacturing TechnicianBiotech Manufacturing AssociateProduction TechnicianGMP Manufacturing AssociateQuality Manufacturing TechnicianDrug Product Manufacturing TechnicianCandidates with 1+ year of GMP/cGMP manufacturing experience, strong documentation skills, MES experience, and a background in pharmaceutical or biotechnology manufacturing are encouraged to apply.