Role Summary
The Maintenance Technician II is responsible for the maintenance and repair of equipment, utilities and systems supporting cGMP Manufacturing, Laboratories, Warehouse and commercial office space. Perform planned and corrective maintenance according to written instructions, diagnose issues in the field in real-time, propose corrective solutions, and complete and review related Facilities GMP documents. Ensure the safety and compliance of all applicable systems.
Responsibilities
- Demonstrate a strong understanding of HVAC, mechanical, electrical and process utilities systems, and be able to troubleshoot and repair.
- Perform repairs/installations/upgrades to building components, including plumbing, electrical, HVAC, carpentry, painting, furniture, flooring and any other general repairs as necessary.
- Ability to read and interpret engineering and architectural drawings, including floor plans, reflected ceiling plans, power plans, panel schedules, mechanical/plumbing piping diagrams, Piping & Instrumentation Diagrams (P&IDs)
- Responsible for installing/reconfiguring furniture, chairs and associated equipment, and coordinate/assist with personnel moves within the facility.
- Accountable for the safety of all personnel and equipment within the facility.
- Monitor and respond to alarms generated from the BMS/QEMS, including on-call.
- Work with management to develop spare parts plans and ensure adequate inventory is maintained and tracked to support the maintenance and operation of the facility and equipment.
- Receive, filter and execute work order requests as necessary.
- Ensure that any equipment repairs or maintenance activities are compliant with any applicable building codes.
- Maintains records on equipment manufacturers’ technical notices, upgrades and safety issues.
- Establishes programs and solutions for increasing up-time and for equipment problems that affect the manufacturing process.
- Work with external vendors for the service and/or repair of equipment.
- Conduct routine inspections of premises and equipment.
- Investigating problems and diagnosing and repairing faults.
- Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
- Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
- Comply with cGMP procedures and policies.
- Perform miscellaneous/ other duties as assigned.
Qualifications
- Required: Requires a minimum of 4 - 6 years of related experience.
- Required: A Philadelphia Engineer Grade A License is required or ability to obtain within 6 months to 1 year.
- Required: A strong background in operations and maintenance of chiller/boiler plants, pumps and AHU’s is required.
- Required: A strong background in operations and maintenance of electrical systems, including Emergency Generators, ATS’s and Switchgear is required.
- Required: Experience using Computerized Maintenance Management Software (Blue Mountain) is required.
- Required: Experience using Building Management Systems and Environmental Monitoring Systems (Siemens Desigo or Insight) is required.
- Required: Excellent oral and written communication skills required.
- Required: Must have valid driver’s license
- Preferred: 4-6 years of related Facilities and Maintenance experience preferred.
- Preferred: Prior experience in cell therapy manufacturing or BioPharma/Life Sciences is highly desirable.
- Preferred: Boiler license and/ or knowledge of boiler operations.
Education
- Associates Degree / Trade School / Technical Certification (HVAC/R, Electrical, Plumbing) or equivalent experience is required.
Skills
- Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadline.
Additional Requirements
- Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
- Must meet requirements for and be able to wear a half-face respirator.
- Able to stand and/or walk 90% (and sit 10%) of a 8-hr day which may include climbing ladders or steps.
- Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
- Must be able to lift and carry objects weighing 50 pounds.