Facilities Engineer / Specialist
- Expired: May 13, 2022. Applications are no longer accepted.
Iovance Biotherapeutics is seeking a Facilities Engineer/Specialist to join the Technical Services team. Iovance is an immune-oncology company focused on the development and commercialization of novel cancer immunotherapies based on tumor infiltrating lymphocytes (TIL). The companies lead candidate is an autologous, ready-to-infuse cell therapy, that has demonstrated distinctive efficacy in the treatment of metastatic melanoma. The company has Phase 2 clinical trials in progress for squamous cell carcinoma of the head and neck, cervical carcinoma, non-small cell lung cancer, and immunotherapy for solid tumors. The company currently is developing its commercial manufacturing capacity to support development and launch of these assets.
The Facilities Engineer/Specialist is responsible for the operation and optimization of the equipment, systems, and utilities of a GMP Manufacturing Facility. This role will dedicate approximately 50% of it's time supporting the Cell Therapy Center manufacturing facility located at 300 Rouse Blvd, Philadelphia, PA as well as a satellite GMP manufacturing facility located at 700 Spring Garden St, Philadelphia, PA. Co-located at the American Red Cross Penn/Jersey Region, this Iovance facility produces a critical raw material used in the company's TIL process.
This individual will be directly responsible for coordinating all Facilities Engineering activities at the Spring Garden location, and will interface with MS&T as well as the property owner for all Facilities and Maintenance related activities.
- Demonstrate a strong understanding of HVAC, mechanical and electrical systems, and be able to troubleshoot as necessary.
- Prior experience working with cell therapy processing and laboratory equipment is highly desirable, including; BSC's, incubators, refrigerators, centrifuges, -80C freezers and LN2 freezers.
- Monitor the utilities (CO2 and LN2) at the Spring Garden location daily, reorder and replace equipment to ensure reliable and uninterrupted supply.
- Provide engineering and/or technical expertise and support to all departments as needed.
- Provide engineering and/or project management support for all Facilities projects.
- Monitor and respond to alarms generated from the BMS/QEMS, including off-hours and weekends.
- Schedule, coordinate and escort external vendors for maintenance and calibration activities
- Responsible for launching investigations, deviations, CAPAs, etc. related to GMP facilities, utilities, and equipment.
- Develop and enhance departmental standard operating procedures.
- Participate in the planning, design, budgeting, scheduling and execution of assigned projects.
- Conduct routine inspections of premises and equipment.
- Investigating problems and diagnosing and repairing faults.
- Ensure safe working conditions.
- Other duties as required.
- BS or MS in Engineering or Technical field is required, or equivalent experience.
- 3+ years of related BioPharma/Life Sciences experience required. Prior experience in cell therapy manufacturing is highly desirable.
- Has comprehensive understanding of principles, theories, concepts, and industry practices and standards and their application.
- Extensive knowledge of small-scale cell culture processes and techniques is preferred.
- Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations is preferred.
- Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
- Experience interfacing with other design disciplines including automation, facility design and mechanical design groups is required.
- Experience interfacing with CQV and operations teams is required.
- Experience using Computerized Maintenance Management Software (Blue Mountain) is preferred.
- Experience using Building Management Systems (Siemens - Apogee/Desigo) and Environmental Monitoring Systems is required.
- Demonstrable experience on cGMP capital, maintenance, and operating projects.
- Excellent oral and written communication skills required.
- Stand for long periods of time
- Ability to squat, crawl and climb ladders
- Ability to lift 50lbs
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