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Lead CMMS Specialist

3 months ago

Philadelphia, United States Iovance Biotherapeutics Inc Full time
Job DescriptionJob DescriptionSalary:

Overview


We are currently searching for a skilled professional to join our Facilities Engineering team as a Lead CMMS Specialist in our GMP Manufacturing Facility in the Navy Yard, Philadelphia. The onsite role will support the Maintenance and Metrology teams and assist all site departments to ensure the equipment is in a compliant state. If you are a career-focused professional, this is the role for you.

 

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.


Essential Functions and Responsibilities


  • Manage the daily operation of the Computerized Maintenance Management System (CMMS) and acts as the Facilities admin of the system, ensuring it is maintained in a state of compliance.
  • Ensure data records are current, accurate, and compliant with good documentation practices (GDP), quality compliance requirements, and applicable standard operating procedures.
  • Track and keep maintenance records for audit compliance in accordance with internal quality and external regulatory requirements.
  • Maintain and track equipment status and facilitate tagging equipment in/out of service.
  • Follow up with technicians to ensure all due dates/documentation best practices are being followed.
  • Provide or suggest business processes to optimize workflow and maximize data capture.
  • Assess the scope of work and assign the work order to correct trade technician.
  • Receive and interpret technician feedback on work orders to determine how to advance work through to completion.
  • Coordinate daily/weekly/monthly schedules with equipment owners and site scheduler to minimize conflicts and maintain facility uptime.
  • Balance monthly preventive maintenance, calibration, and corrective workload to labor availability
  • Create and run reports tracking metrics, to include work order status, spare parts, past due, etc.
  • Support work order completion and closeout to maintain compliance.
  • Support maintenance and calibration spare parts inventory, tracking and procurement.
  • Dispatch emergency work requests.
  • Perform miscellaneous duties as assigned.


Required Education, Skills, and Knowledge


  • Bachelor’s degree, or Associates with 10 years of experience is required.
  • Minimum 5 years’ experience working with Blue Mountain Regulatory Asset Management (BMRAM) is required.
  • Knowledge of GMP Metrology, Maintenance and Manufacturing/QC Operations is required.
  • Excellent communications skills
  • Strong team player and ability to build positive collaboration with internal stakeholders, vendors, and clients
  • Highly flexible, well-organized, and detailed-oriented
  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
  • You are an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
  • Problem-Solvers. As an action-oriented self-starter, you are eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
  • You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
  • Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.


The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

 

Physical Demands and Activities Required:

 

  • 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 10-hr day which may include climbing ladders or steps.
  • Must be able to use near vision to view samples at close range
  • Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
  • Must be able to lift and carry objects weighing 50 pounds.


Mental:

  • 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

 

Work Environment:

  • This position will work in both an office and a manufacturing lab setting.
  • When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
  • Able to work in cleanroom with biohazards, human blood components, and chemicals.
  • Potential exposure to noise and equipment hazards and strong odors.

 

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

 

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.

 

 By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice. 


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