Sr. Maintenance Operations Technician - Sanford, United States - Astellas Pharma

Description

About Astellas Gene Therapies

Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: .

The Role:

The Senior Maintenance & Operations Technician will be part of the Facilities & Engineering department supporting the manufacturing, labs, warehouse, and administrative areas. This position will be part of a core team that ensures the facilities, utility systems, HVAC, refrigeration, electrical, and process/lab equipment remain in optimal operating condition. Based on business and operational needs, this role may serve as the subject matter expert in HVAC – Refrigeration and/or may also serve as the subject matter expert in Electrical systems.

Responsibilities:

• Perform the day-to-day operations of the central utility plant (CUP) in a safe and compliant manner using automated systems (e.g., BMS & EMS) and SOPs.
• Provide emergency and off-hour response (on a rotating basis including holidays) to alarms and lead troubleshooting and recovery efforts.
• Communicate safety, quality, technical and training issues to team and escalates non-conformances to management, initiate deviation/incident records, and participate in investigations as necessary.
• Ensure facilities are fit for use by maintaining cGxP and safety standards and plans and performs routine and repair maintenance.
• Collaborate with management and planning to procure parts and services as necessary and oversee and escort vendors performing maintenance or providing services.
• Create and complete work orders using a CMMS to maintain the facilities, utility systems, process, and lab equipment and ensure maintenance records are documented accurately and completely following GDP.
• Complete required training on schedule and maintain accurate training records and read and interpret blueprints, schematics, equipment/service manuals, logic flow diagrams, and work orders to perform required operations, maintenance, and troubleshooting of systems/equipment.
• Use electronic/automated systems to trend performance and troubleshoot issues.
• Create, revise, and maintain the maintenance plans, spare parts inventory, and SOPs.
• Partner with internal customers, colleagues, and support services to achieve department goals and understand and adhere to internal and external regulations, procedures & policies.

Required Qualifications:

• High School diploma or GED with 6+ years of maintenance and operating experience in a GXP environment or comparable field or 4+ years of experience with applicable degree/certification/license (e.g., plumber, electrician, HVAC technician) plant maintenance experience with knowledge of technical craft skills (instrumentation, electrical, plumbing, advanced mechanical, or refrigeration).
• 4+ years of experience maintaining and operating a utility plant with a BMS including AHUs, chillers, hot water boilers, compressed air generation and distribution gas, purified water, and wastewater treatment system.
• 4+ years of experience in maintenance, HVAC&R (refrigeration, air handlers) or electrical.
• Strong troubleshooting skills for electro-mechanical PLC, control valves and automated systems. Ability to perform right-first-time testing, adjustments, and repairs using approved procedures or technical experience when no procedure is available.
• Demonstrated experience reading and interpreting blueprints, schematics, equipment/service manuals, logic flow diagrams, and work orders.
• Strong GxP knowledge and documentation skills.
• Good oral and written communication skills Demonstrated experience using a variety of hand and power tools, electric meters, ladders, and safety equipment in performing duties.
• Team player with a successful history of working with other internal departments and external vendors.
• Proficiency with computerized systems such as CMMS and BMS, EMS, Excel, and MS Office suite
• Flexible and able to excel and adapt to rapidly changing situations.
• Self-motivated and can handle multiple jobs with minimal supervision.
• Works closely with team and other functional key stakeholders on the Astellas Technical Operations team to execute work and will be expected to perform other duties and/or special projects as assigned.
• Dependable and exhibits regular and predictable attendance and the flexibility to work various shifts.
• Develops Standard Operating Procedures (SOPs) and Preventative Maintenance (PM) plans as requested.
• Actively supports, participates, and embraces an inclusive team culture including significant interaction with operations, quality, automation, technology, and other groups as required.
• Ability to perform routine maintenance tasks, work with and troubleshoot complex process systems, including but not limited to:

Process Equipment (e.g., Filling Machine, Bioreactors, Autoclaves, Glass Washers)

Utility Equipment (e.g., Chillers, Boilers, Clean steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems)

• Interact with vendors other departments, contractors and disciplines on scheduling repairs, maintenance/projects, equipment testing, parts, troubleshooting and coordination activities like FAT, SAT, design reviews, and engineering assessments.

Preferred Qualifications:

• Pharmaceutical or Biotech experience
• Completion of a craft apprenticeship
• Working experience planning and scheduling maintenance using a CMMS
• Experience in maintaining adequate on-hand spare parts inventory or lead-time system in place to support responsible equipment.
• Understanding of PLC and BAS troubleshooting and programing

Working Conditions:

• This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 50 lbs.
• This is an on-site role working in a cGMP regulated manufacturing facility.
• On occasion, this role may travel to other Astellas Gene Therapies manufacturing facilities (0-5%).

Benefits:

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
• 401(k) match and annual company contribution
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Referral bonus program

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.