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Calibration Manager

Company: CRISPR Therapeutics
Location: Framingham
Posted on: May 9, 2022

Job Description:

Company Overview CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom. Job Summary CRISPR is seeking a Calibration Manager to join an exciting, fast-growing, and well-financed company developing novel gene editing therapies for serious diseases at CRISPR Therapeutics. The successful candidate will oversee and direct the day-to-day facility operation and Maintenance staff for a new cGMP manufacturing facility located in Framingham, MA. Responsibilities will include supporting the Facilities Site Head with the commissioning of a cutting-edge cGMP manufacturing facility for our immuno-oncology product portfolio. This position, as part of the project team, will work closely with Engineering through the validation of the Facility. Following successful commissioning, the role will be responsible for the management of contract support and day-to-day supervision of all calibration activities. The ideal candidate has prior experience in the operation and calibration, of cGMP manufacturing facilities utility systems and process equipment, as well as proven leadership skills. Responsibilities Maintain a safe work environment, work in a safe manner following all safety SOP---s and assure use of all required Personal Protective Equipment. Maintain assigned area of ownership within the facility to support inspection readiness of the Manufacturing site. Assure the on-time completion of all Calibration. Maintain all calibration records, work orders, and investigations in an orderly and accurate manner in compliance with cGMP---s by the utilization of the site CMMS and Quality Management Systems. Management and improvement of the calibration program, procedures, and practices. Calibration technician workload planning per the schedule maintained in the Blue Mountain RAM CMMS system. Management of external calibration activities with 3rd party suppliers. Performance of the following tasks either directly or by technician/contractor staff: Perform calibration work on complex instruments, laboratory equipment, and other manufacturing and utility system instrumentation. Perform troubleshooting, installations, and repairs of complex instrumentation on production, laboratory, and facility systems, ensuring all calibrations are in accordance with manufacturer---s specifications. Work with equipment owners to determine the appropriate calibration information for their processes through the evaluation of instrument specifications. Support and participate, as needed, in Regulatory and Internal Audits / Inspections. Support qualification activities related to instrumentation and process improvement projects. Manage all off-site calibration activities, including but not limited to, quoting calibration with vendors, interfacing with calibration contractors, and ensuring work is compliant with CRISPR SOP---s and cGMP---s. Oversee all review and development of calibration department procedures. Support investigations and initiation of any documentation resulting from ---Out of Tolerance--- conditions with respect to instrumentation. All other duties as assigned. Minimum Qualifications Associate Degree in Instrumentation or a related discipline highly desired In the absence of a formal Associates Degree, the expectation is that the successful candidate would have a minimum of 7 years of overall experience in calibration activities, of which at least 3 years must be in a cGMP or other FDA regulated operations demonstrated success in building & leading high-performing calibration teams for at least 5 years. Those with the Associates Degree will be considered with a minimum of 5 years of overall experience in calibration activities, of which at least 3 years must be in a cGMP or other FDA regulated operations demonstrated success in building & leading high-performing calibration teams for at least 3 years preferably Strong knowledge of calibration procedures and techniques, including calibration of temperature, pressure, electronic, flow, weight, level, speed, PH & conductivity etc. In-depth knowledge of calibration and documentation requirements for cGMP manufacturing. Proven ability to effectively lead, influence and course correct as needed. Experience in the planning of facilities responsibilities including a calibration, maintenance, and training program, as well as installation of new equipment and systems. Experience interfacing with multiple external vendors. Ability to effectively communicate and collaborate with internal and external stakeholders. Ability to work effectively in a collaborative team environment. Strong knowledge, troubleshooting skills and maintenance competence on GMP utilities and equipment. Proficient knowledge of controls and automation. Self-driven, independently motivated, data driven and excellent problem-solving ability. Proficient in use of CMMS and BMS systems. Experience with Blue Mountain and/or Alberio systems a plus. Must be willing to work shift work. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy

Keywords: CRISPR Therapeutics, Framingham , Calibration Manager, Executive , Framingham, Massachusetts

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