AGC Biologics

Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics.. Demonstrated high level of expertise operating utility systems such as steam boilers, boiler feedwater, electrical, fire/life safety, hot and chilled water, compressed air and gases, wastewater treatment, dust collection, municipal water treatment, purified water, water for injection (WFI), tempered water, backup power generation, and HVAC. Advanced knowledge of pneumatic, mechanical, electrical, water treatment, and hydraulic fundamentals. Purified Water Systems (RO, DI, WFI), Clean Steam, and Clean Compress Air. Modular Process Skids, CIP, TCU

technician i

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, on time. For more information, visit www.agcbio.com. JOB SUMMARY The Utilities Technician I-Senior is a skilled craftsperson responsible for the operation, monitoring, troubleshooting, maintenance, repair, testing, and documentation of a wide variety of manufacturing process and general utilities. May perform general labor duties as needed and work outside of core business hours upon short notice. Work performed must be completed with minimal impact to production and business operations, and must be documented/logged in accordance with written SOP's, GMP and AGC Biologics' guidelines as applicable. This role is a night shift position. Hours are 6 pm to 6:30 am The shift is a 2 2 3 schedule Week 1: Off: Monday Tuesday Work: Wednesday Thursday Off: Friday Saturday Sunday Week2: Work: Monday Tuesday Off: Wednesday Thursday Work: Friday Saturday Sunday Repeats each week ESSENTIAL DUTIES AND RESPONSIBILITIES <ul> <li>Under general supervision, perform advanced installation, maintenance, troubleshooting, repair, and testing of a wide variety of facility and manufacturing utility systems used in a GMP Biopharmaceutical manufacturing facility</li> <li>Monitor system operation performance via a computerized building management system and in-the-field monitoring</li> <li>Perform sanitizations and passivation of utility equipment as appropriate</li> <li>Work under general direction of project engineers or section head, or under general administrative instruction performing detailed maintainability studies and calculations of component/system downtime</li> <li>Help establish good maintenance practices</li> <li>Operate, log, and maintain utility systems in accordance with standard operating procedures</li> <li>Assist management in development of work-related programs and standard operating procedures</li> <li>Complete routine request work orders and Preventative Maintenance (PM) work orders</li> <li>Present reliability, safety, and cost savings improvement ideas</li> <li>Assist with the execution of validation protocols or change controls as needed</li> <li>Provide detailed training for the team in order to develop the team's knowledge in the utility operation field and other areas of the plant</li> <li>Maintain personal training records and takes charge of own training and ongoing education</li> <li>Other duties and responsibilities as assigned</li> </ul> KNOWLEDGE, SKILLS, AND ABILITIES To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. <ul> <li>Demonstrated high level of expertise operating utility systems such as steam boilers, boiler feedwater, electrical, fire/life safety, hot and chilled water, compressed air and gases, wastewater treatment, dust collection, municipal water treatment, purified water, water for injection (WFI), tempered water, backup power generation, and HVAC</li> <li>Ability to work outside of core business hours upon short notice, including shift work</li> <li>Ability to work in awkward locations</li> <li>Ability to lift items in excess of 40 pounds with or without assistance</li> <li>Demonstrated understanding of and ability to comply with all company health and safety procedures and practices</li> <li>Advanced knowledge of pneumatic, mechanical, electrical, water treatment, and hydraulic fundamentals</li> <li>Advanced skills in the use of power and hand tools</li> <li>Demonstrated ability to effectively communicate ideas through verbal and written forms</li> <li>Ability to interact constructively with peers/teams, and can seek outside resources as needed</li> <li>Knowledge of MS Word and MS Excel desired</li> <li>Practical knowledge of GMP's and working in an SOP environment</li> <li>Technical writing skills preferred</li> <li>Knowledge and experience of regulatory requirements of ISO and GMP preferred</li> </ul> EDUCATION and/or EXPERIENCE <ul> <li>Level IV requires 8+ years' experience in equipment maintenance (depending on title), including operation, troubleshooting, and repair of utility systems preferably in a GMP manufacturing plant</li> <li>Level III requires 5 to 7 years' experience in equipment maintenance (depending on title), including operation, troubleshooting, and repair of utility systems preferably in a GMP manufacturing plant</li> <li>Level II requires 2 to 4 years' experience in equipment maintenance (depending on title), including operation, troubleshooting, and repair of utility systems preferably in a GMP manufacturing plant</li> <li>Level I requires 0 to 2 years' experience in equipment maintenance (depending on title), including operation, troubleshooting, and repair of utility systems preferably in a GMP manufacturing plant</li> </ul> <ul> <li>Experience with the following systems/processes highly desired:</li> </ul> <ul> <ul> <li>Purified Water Systems (RO, DI, WFI), Clean Steam, and Clean Compress Air</li> <li>Incubators, Compressed gas (CO2, O2, N2)</li> <li>Fire/Life Safety</li> <li>Modular Process Skids, CIP, TCU</li> <li>HVAC, Waste treatment and Bio-inactivation systems</li> </ul> </ul> COMPENSATION RANGE: $21.19-49.55 hourly based on experience Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities. Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave. Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company's performance and the Team Member's performance. AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

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