Equipment Maintenance Technician - Aseptic & Packaging Systems 2nd Shift
hace 19 días
Sacramento
Job Description About the Company: Nivagen is a global company devoted to improving lives by developing high-quality, affordable generic prescription drugs and over-the-counter products for the North American market. For over a decade, we have remained committed to our core values of excellence, integrity, and respect for people. Our dedicated team works collaboratively to advance manufacturing, distribution, and quality control, taking a comprehensive approach to healthcare. Through vertical integration of the pharmaceutical supply chain, state-of-the-art technology, and an unwavering focus on excellence, we continually strive to enhance medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and strong training and development programs. By investing in our workforce and nurturing a culture of growth and support, we empower our team to drive innovation and make a positive impact in healthcare. Our mission at Nivagen is clear: to improve lives by providing high-quality, affordable medications while upholding the highest standards of integrity and excellence. As a leader in pharmaceutical manufacturing, Nivagen is committed to producing sterile products that meet the healthcare industry's rigorous demands. Specializing in the production of vials, pre-filled syringes (PFS), and IV bags, we aim to make a meaningful impact on patient care. Join our team to help push the boundaries of sterile manufacturing, achieving the highest standards in safety, quality, and operational efficiency. Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Equipment Maintenance Technician – Aseptic & Packaging Systems Department: Maintenance/Engineering/Manufacturing Operations Reports to: Maintenance Supervisor/ Facilities & Engineering Manager Job Summary: The Equipment Maintenance Technician - Aseptic & Packaging Systems is responsible for performing preventive maintenance, corrective maintenance, troubleshooting, repairs, and technical support for manufacturing equipment used in a cGMP-regulated pharmaceutical manufacturing environment. This role supports aseptic processing, sterile filling, inspection, packaging, and related manufacturing operations. Equipment may include isolators, Restricted Access Barrier Systems (RABS), vial filling lines, syringe filling systems, cartridge equipment, flexible container/bag filling systems, pumps, conveyors, cappers, labelers, serialization systems, inspection equipment, and packaging equipment. The Equipment Maintenance Technician plays a critical role in maintaining equipment reliability, minimizing downtime, supporting production schedules, and ensuring work is performed safely and in compliance with GMP, GDP, safety, and data integrity requirements. Responsibilities: • Perform preventive, corrective, and emergency maintenance on pharmaceutical manufacturing equipment., • Troubleshoot and repair mechanical, electrical, pneumatic, hydraulic, and automated equipment issues., • Support equipment used in formulation, sterile filling, inspection, packaging, labeling, and material handling operations., • Perform equipment setup, adjustments, alignments, component replacement, lubrication, calibration support, and functional testing., • Respond to production equipment breakdowns and support timely return to service., • Maintain and support equipment used in aseptic manufacturing environments, including isolators, Restricted Access Barrier Systems, vial filling equipment, prefilled syringe filling equipment, cartridge filling systems, flexible container/bag filling systems, and stoppering, capping, sealing, and closure systems., • Support production equipment operating in or adjacent to Grade B, Grade C, Grade D, and controlled manufacturing areas., • Follow cleanroom gowning, contamination control, and aseptic behavior requirements when performing work in classified areas., • Support equipment readiness, line clearance, changeover, startup, and shutdown activities., • Coordinate with Manufacturing, Quality Assurance, Engineering, Validation, Automation, and Facilities to maintain compliant equipment operation., • Maintain and troubleshoot packaging and inspection equipment including labelers, cartoners, case packers, conveyors, vision inspection systems, serialization and aggregation systems, checkweighers, and coding systems., • Support packaging line changeovers, format part changes, setup verification, and operational troubleshooting., • Assist Manufacturing and Packaging teams during equipment startup and routine production execution., • Support inspection and packaging equipment readiness for GMP production and line clearance activities., • Escalate equipment issues that may impact product quality, labeling accuracy, serialization integrity, or batch execution., • Complete maintenance documentation accurately, contemporaneously, and in accordance with Good Documentation Practices., • Document work orders, parts usage, equipment history, and maintenance activities in CMMS such as SAP PM, Maximo, Blue Mountain, or equivalent system., • Follow approved SOPs, maintenance procedures, safety procedures, and equipment manuals., • Identify and escalate GMP-impacting equipment issues, deviations, or abnormal conditions., • Support deviation investigations, CAPAs, change controls, audit readiness, and inspection activities as required., • Diagnose equipment failures and determine appropriate corrective actions., • Use technical manuals, schematics, drawings, wiring diagrams, P&IDs, and equipment documentation to support troubleshooting., • Assist with root cause analysis for recurring equipment failures or production interruptions., • Partners with Manufacturing, Quality Assurance, Engineering, Automation, Validation, and Facilities teams to resolve equipment issues., • Support equipment improvements, reliability initiatives, and continuous improvement projects., • Execute scheduled preventive maintenance tasks in accordance with approved procedures and maintenance plans., • Identify opportunities to improve preventive maintenance frequency, scope, and effectiveness., • Support reliability improvement activities to reduce downtime, repeat failures, and production interruptions., • Assist with installation, commissioning, qualification, and startup of new or modified equipment., • Maintain tools, parts, equipment, and maintenance areas in an organized and inspection-ready condition., • Follow all site safety procedures, lockout/tagout requirements, electrical safety practices, chemical handling requirements, and PPE requirements., • Safely work around operating equipment, moving parts, compressed air, utilities, and controlled environments., • Maintain a safe, clean, and organized work area., • Participate in safety investigations, near-miss reporting, and continuous improvement initiatives., • Support a culture of safety, quality, compliance, and operational excellence. Education/Experience: • High school diploma or GED required., • Associate degree, technical certificate, trade school certification, or equivalent training in industrial maintenance, mechanical technology, electrical technology, automation, manufacturing technology, or related field preferred., • Minimum of 2-5 years of maintenance experience in pharmaceutical, biotechnology, medical device, food, chemical, semiconductor, or other regulated manufacturing environment preferred., • Experience maintaining manufacturing, packaging, or automated production equipment required., • Experience working in a GMP-regulated environment preferred., • Experience supporting aseptic processing, sterile manufacturing, or cleanroom equipment strongly preferred. Preferred Qualifications: • Experience with aseptic filling equipment for vials, syringes, cartridges, or flexible containers/bags., • Experience with isolators, RABS, VHP systems, sterile barriers, or cleanroom equipment., • Experience with packaging equipment, labeling systems, vision systems, serialization, and aggregation systems., • Familiarity with PLC/HMI troubleshooting, preferably Allen-Bradley, Siemens, or similar platforms., • Experience with SAP PM, Maximo, Blue Mountain, or equivalent CMMS., • Experience supporting equipment qualification, validation, FAT/SAT, or commissioning activities., • Knowledge of lockout/tagout, electrical safety, confined space, and hazardous energy control., • Experience in sterile drug product, biologics, vaccines, or parenteral manufacturing. Physical Requirements/ Working Conditions: • Ability to stand, walk, bend, stoop, kneel, crouch, crawl, climb, and reach during maintenance activities., • Ability to lift, carry, push, or pull tools, parts, and equipment up to 25-50 pounds, in accordance with site safety procedures., • Ability to work around moving machinery, conveyors, pumps, motors, utilities, and production equipment., • Ability to use hand tools, power tools, meters, diagnostic equipment, and maintenance instruments., • Ability to wear required PPE, including safety glasses, gloves, hearing protection, cleanroom gowning, and respiratory protection where required., • Ability to work in cleanroom gowning for extended periods., • Ability to visually inspect equipment, components, labels, documentation, and equipment status indicators., • Ability to work overtime, weekends, holidays, alternative shifts, or on-call assignments as business needs require. Work Environment • Work is performed in a GMP pharmaceutical manufacturing facility, including production areas, packaging areas, maintenance shops, utility spaces, cleanrooms, and controlled environments., • Work may occur in Grade B, Grade C, Grade D, and support areas depending on equipment and production needs., • The work environment may include exposure to operating equipment, moving parts, compressed air, cleaning agents, disinfectants, controlled temperatures, noise, and manufacturing materials., • Strict adherence to gowning, hygiene, safety, contamination control, and documentation procedures is required., • This position requires on-site presence and is not eligible for remote work. Schedule / Shift Requirements • Position is for 2nd Shift ONLY (2:00 PM-10:30 PM) Benefits: • Pay range: $70,000- $80,000, • Yearly bonus eligibility, • Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being (Medical, dental and vision coverage), • Paid time off plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors. We are focused on building a diverse and inclusive workforce. If you're excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.
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