Regulatory Lab Technician (Equipment)

Job Type:LOC_COLKET-Colket Translational Research Req ID: 36761Shift: DaysEmployment Status: Regular - Full Time Job SummaryThe Clinical Vector Core (CVC) is a division of the Raymond G. Perelman Center for Cellular and Molecular Therapeutics (CCMT) at the Children’s Hospital of Philadelphia. The CCMT fosters a multidisciplinary approach to develop cures for debilitating and life-threatening genetic disorders using innovative gene and cell therapy approaches.
CVC operations include manufacturing, quality control testing, and certification of recombinant adeno-associated and lentiviral viral vectors for use as Investigational Drugs in pre-clinical and early-phase clinical studies. CVC operations comply with FDA’s current Good Manufacturing Practice regulations and other regulatory standards and guidelines applicable to early-phase Investigational Drugs. Vectors are made available to clinical programs in academia, industry and government in the U.S. and abroad.
This role plays a vital role in supporting the day-to-day operations of the Clinical Vector Core to assure the highest achievable quality and consistency of products, adherence to standards established in the CVC, and compliance with cGMP regulations.
This role is responsible for receiving, registering, tagging, and installing equipment, initiating change requests, incident reports and planned deviations, scheduling and overseeing execution of facility and equipment maintenance, repair, calibration, and validation, drafting facility and equipment SOPs, and investigating OOS conditions and malfunctions according to established standard operating procedures (SOPs). The position requires good documentation practices, team work, and an ability to consistently perform in a GMP environment.
All employees are responsible for compliance with written policies and procedures and for correctness, truthfulness, timeliness, legibility, integrity, and accuracy when recording data and observations in compliance with current cGMP regulations.
Job Responsibilities

• Performs general duties
• Responsible for investigating OOS conditions and malfunctions
• Responsible for scheduling and overseeing execution of facility and equipment maintenance, repair, calibration, and validation
• Maintains and organizes equipment files
• Responsible for receiving, registering, tagging, and installing equipment
• Performs tasks per facility and equipment SOPs
• Reviews facility and equipment records
• Drafts facility and equipment SOPs and work instructions
• Initiates change requests, incident reports and planned deviations
• Drafts investigations
• Trains and supervises junior personnel
• Performs other duties as assigned
  

Required Licenses, Certifications, RegistrationsRequired Education and ExperienceRequired Education: Bachelor’s degree

Required Experience:

• Three (3) years of facilities, equipment or operations experience

Preferred Education, Experience & Cert/LicPreferred Education: Master’s degree
Preferred Experience:

• Five (5) years of facilities, equipment or operations experience
• Three (3) years of relevant experience in cGMP/GLP (or other regulated) environment.

Preferred Licenses/certificates/registrations:

• Current Good Manufacturing Practices (cGMP) certification or within 180 days of placement into position.

Additional Technical Requirements

• Demonstrated ability to prioritize work, strong organizational and documentation skills and initiative to improve processes.
• Change agent demeanor. Must be a flexible thinker, with an ability to quickly adapt to a rapidly changing environment.
• Team-oriented, self-starting individual with good communication skills.
  

All CHOP employees who work in a patient building or who provide patient care are required to receive an annual influenza vaccine unless they are granted a medical or religious exemption.Children's Hospital of Philadelphia is committed to providing a safe and healthy environment for its patients, family members, visitors and employees. In an effort to achieve this goal, employment at Children's Hospital of Philadelphia, other than for positions with regularly scheduled hours in New Jersey, is contingent upon an attestation that the job applicant does not use tobacco products.Children's Hospital of Philadelphia is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability or protected veteran status.VEVRAA Federal Contractor/Seeking priority referrals for protected veterans. Please contact our hiring official with any referrals or questions.CHOP Careers ContactTalent Acquisition2716 South Street, 6th FloorPhiladelphia, PA 19146