Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.
JOB SUMMARY
The Maintenance Technician, Senior is a skilled multi-craftsperson responsible for performing advanced installation, troubleshooting, maintenance, repair, testing, and documentation/logs of a wide variety of manufacturing production equipment and process utilities. The Maintenance Technician, Senior will also provide maintenance and support to GMP facilities and utility systems. All work must be completed with minimal impact on production while complying with cGMP, when appropriate, and AGC regulations.
You may perform general labor duties as needed and work outside of core business hours upon short notice.
ESSENTIAL DUTIES AND RESPONSIBILITIES
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Under general supervision, perform advanced installation, maintenance, troubleshooting, repair, and testing, of a wide variety of GMP’s manufacturing equipment, laboratories equipment, clean & non-clean utilities used in GMP Biopharmaceutical manufacturing facility.
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Gathers and examines basic maintainability problem data from field studies or database and merges data into well-defined repair techniques, principles and procedures.
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Works under general direction of project engineers or section head, or under general administrative instruction in performing detailed maintainability studies and calculations of component/system downtime. Helps establish good maintenance practices.
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Operates, logs, and maintains manufacturing and GMP’s utility systems in accordance with Standard Operating Procedures.
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Completes routine request work orders and Preventive Maintenance (PM) work orders.
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Work performed must be completed and documented/logged in accordance with written SOPs and GMP guidelines, where applicable.
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Supports plant utilities and improvement projects including Mechanical/Electrical/Plumbing (MEP), control systems, security, fire alarm, etc.
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Reviews and technically approves maintenance reports, forms, and records.
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Develops, revises, and reviews equipment, maintenance or other related procedures.
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Prepares, plans and performs manufacturing equipment moves and installations.
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Assists and may lead the start-up of new equipment to ensure it meets all mechanical design specifications
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Interprets and redlines electrical schematics, P&IDs, panel/building drawings, and equipment/building O&M manuals.
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Assists with the preparation and execution of validation protocols.
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Provides detailed training for the team in order to develop the team’s knowledge in the maintenance field and other areas of the plant
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Required to work in clean rooms and restricted environments using specific procedures
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Other duties and responsibilities as assigned
KNOWLEDGE, SKILLS, AND ABILITIES
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Advanced knowledge of pneumatic, mechanical, and hydraulic fundamentals
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Advanced skills in the use of power and hand tools
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Effectively communicates ideas through verbal and written forms, interacts constructively with peers/teams, and can seek outside resources as needed
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Possess a high mathematical understanding, excellent reading and computer skills
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Knowledge of MS Word and MS Excel
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Knowledge and experience of regulatory requirements of ISO and GMP preferred
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Knowledge of change control and validation concepts preferred
EDUCATION and EXPERIENCE
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AA/AS degree in Industrial Mechanic, equivalent trade school associate degree, or former industrial maintenance craft background supplemented by night school training
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Seven (7) + years of combined education and experience in GMP equipment maintenance, including troubleshooting and repair of Biopharmaceutical manufacturing equipment such as: Bioreactors, Pumps, Mixers, Clean utilities (WFI, Clean Steam, Clean Compress Air), HVAC, and laboratory process equipment used in a GMP manufacturing utility plant
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Equivalent education and experience may substitute for the stated requirement
COMPENSATION RANGE
$36.06 - $49.55 per hour depending on experience
Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.
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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.