Senior Metrology Specialist

Overview

The Sr. Metrology Specialist calibrates and repairs equipment and systems supporting cGMP Manufacturing, Laboratories, and Warehouse. Perform calibrations using appropriate procedures and standards for various utilities, equipment, and instruments.

Schedule: Monday to Friday. 

Hours: 7am-3:30pm or 7:30am-4pm

Essential Functions and Responsibilities   

• Supports Metrology group to assure that required manufacturing, laboratories, utilities, and facilities equipment calibrations are performed in compliance with NIST, cGMP regulations, company policies and procedures and meet Federal and local governmental regulation (e.g., FDA, EQB, OSHA, etc.).
• Must be knowledgeable in using a wide range of standards, including temperature, relative humidity, differential pressure, CO2, flow, conductivity, resistivity, speed, time, pressure, and weight.
• Provide guidance to less experienced technicians on proper technical and procedure execution.
• Develop and collaborate on calibration processes on various laboratory and production equipment.
• Assist with preventive and corrective maintenance activities and ensure that any repairs or maintenance activities comply with the manufacturer’s recommendations.
• Oversee contract service providers to ensure all work and documentation is performed per Iovance policies, procedures and meets all cGMP requirements.
• Manage and provide resources necessary to help investigate any calibration nonconformances.
• Consult with customers regarding their metrology needs, especially compliance issues and investigations.
• Participate in internal and external audits. Calibrate, adjust, and maintain measuring and indicating instruments to meet set standards. Some calibrations will be performed in a clean room environment.
• Ability to read and interpret engineering and architectural drawings, including floor plans, reflected ceiling plans, power plans, panel schedules, Piping & Instrumentation Diagrams (P&IDs)
• Monitor and respond to alarms generated from the Qualified Environmental Monitoring System, including off-hours and weekends.
• Receive, filter, and execute work order requests as necessary.
• Writes and reviews calibration procedures, prepares documentation, inputs data, and generates reports associated with calibration work orders to ensure current Good Manufacturing Practices (cGMP) and change control procedures are followed.
• Able to interact effectively with people to establish and maintain excellent working relationships with internal and external customers at all organizational levels and disciplines in such a way as to facilitate the validation/qualification work.
• Significant abilities and aptitude for analyzing data that detect inconsistencies, determine relative importance and solve complex technical situations based on data.
• Investigating problems and diagnosing and repairing faults.
• Provide “On-Call” support as needed.
• 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.
• Perform miscellaneous duties as assigned.

Required Education, Skills, and Knowledge 

• Bachelor’s degree preferred and/or A.A. degree with 5 years of industry experience.
• 5+ years of Metrology and Calibration experience required.
• Certification from an accredited body, ASQ CCT Certification or equivalent, is required (within 1 year of hire)
• Excellent oral and written communication skills required.
• Must have a valid driver’s license.

Preferred Education, Skills, and Knowledge

• Prior experience in cell therapy manufacturing or BioPharma/Life Sciences is highly desirable.
• Experience working under ISO/IEC 17025 and/or ANSI/NCSL Z540.3 management systems is preferred.
• Direct experience calibrating and maintaining equipment in a regulated environment is preferred.
• Experience using Computerized Maintenance Management Software (Blue Mountain) is preferred.
• Experience using Environmental Monitoring Systems (Siemens Desigo or Vaisala) is preferred.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations is preferred.

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 Requirements

• Must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE),

i.e., scrubs, gowning coveralls, 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.
• Ability to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Ability to stand for long periods.
• Ability to climb ladders.
• Ability to lift 50 lbs.

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 deadlines

Work Environment  

This position will work in both an office and a laboratory setting. When in the lab, there may be a risk of exposure to hazardous or biological waste within the environment through receipt, transport, storage, preparation, dispensing, administration, cleaning, and/or disposal of contaminated areas and waste.

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.

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