Calibration & Maintenance Planner

Cambridge Isotope Separations (CIS) has an outstanding opportunity for an experienced Calibration & Maintenance Planner based onsite in our Xenia, OH location.  CIS is the world leader in the separation of 13C and 18O and is a subsidiary of Cambridge Isotope Laboratories (CIL) in Massachusetts, the world’s leading producer of stable isotopes and stable isotope-labeled compounds.  CIL separates both 13C and 18O at its Xenia, Ohio, facility and has the world’s largest production capacity for both 13C and 18O.  CIL also has the only large capacity nongovernmental D2O (Deuterium Oxide) enrichment columns in the world located at its CIS facility. 

The Calibration & Maintenance Planner will utilize knowledge and understanding of cGMP (Current Good Manufacturing Practices), ISO standards, and Quality Management Systems. Oversee the coordination, compliance, and documentation requirements for process calibration, operation, repair, and maintenance.  Interface with multiple departments (Production Group, Quality Control, Quality Assurance, Operations, Engineering, and Logistics) and external consultants to ensure compliance with the company’s Quality Management System, cGMP, and ISO standards.  This position will assure that equipment is being maintained in an efficient and safe manner to reduce downtime and sustain uptime.  Responsible for coordination of maintenance work, maintaining the preventative maintenance program, developing job plans and maintaining the job equipment history archive.

Responsibilities

• Oversee, document, and lead all appropriate equipment calibrations/qualifications based on business need.
• Coordinate equipment maintenance and calibration.
• Oversee, document, and coordinate facility certifications, including, HVAC maintenance/certification, temperature mapping, HEPA filter maintenance/certification, RODI systems, environmental monitoring (EM) program.
• Coordinate investigations into calibration/certification failures.
• Plan and coordinate the preventive, predictive, and breakdown maintenance of building and lab mechanical, electrical, and instrumentation equipment. 
• Review operating reports, service reports, and inspection records to identify faulty equipment.
• Maintain blueprints, service manuals, work orders, records and prepare reports.
• Write, review, revise and approve maintenance related documents.
• Provide support for various maintenance projects (i.e., Computerized Maintenance Management System CMMS), Asset Management. 
• Utilize CMMS systems for all work performed. Maintain and update all assets in CMMS.
• Update work order status in real time.
• Provide overall support and assistance to Maintenance Manager.
• Schedule and escort vendors to minimize impact to end users.
• Maintain a problem-solving, service-first attitude for all interactions with both internal and external stakeholders.
• Ensure parts are available and external contractors are coordinated for scheduled work.
• Create detailed written job plans for maintenance work that includes, scope, skills, durations, parts, tool, PPE, permits, isolation, preparation work, and any other pertinent information.
• Archive job plans in library for future use.
• Develops scope of work for maintenance work orders.
• Develop a maintenance schedule for execution of work.
• Perform any related work as required.

Requirements

• High school diploma or equivalent.
• Familiarity with quality management systems such as GMP and ISO 9001.
• Work independently and in a team environment.
• Good understanding of facilities management issues and procurement procedures.
• Attention to detail, organizational skills, ability to multitask and follow tasks through to completion. 
• Strong Interpersonal skills.
• Working knowledge of computer applications including Outlook, Word, and Excel.
• Analytical and problem-solving skills.
• Must be able to lift and stack objects up to 50 pounds occasionally and exert 10 to 20 pounds of force to lift, carry, push, and pull or otherwise move objects.
• Must be available for Call-in work and perform other duties as required.

Benefits

CIL and CIS offer a competitive salary and comprehensive benefits including generous paid time off, Long Term Incentives, 6% matching 401K plan and health insurance with no in-network deductible.

CIL is an EEO/Affirmative Action employer.

Learn more about us on our website: www.isotope.com

About Us:

Cambridge Isotope Laboratories, Inc. (CIL) is the world’s leading producer of stable isotopes and stable isotope-labeled compounds. With approximately 750 employees and laboratories in four countries, CIL specializes in the process of labeling biochemical and organic compounds with highly enriched, stable (nonradioactive) isotopes of carbon, hydrogen, nitrogen and oxygen. Our chemists substitute common atoms (e.g., 1H, 12C, 14N, 16O) with rare, highly valued isotopes (e.g., 2H or D, 13C, 15N, 18O) so that the final product can be readily measured or traced using mass spectrometry (MS) or nuclear magnetic resonance (NMR). CIL’s products are utilized in laboratories, medical, government and academic research centers and health care facilities worldwide.

We are proud that CIL products have contributed to medical advancements in cancer research, new-drug development, environmental analysis, and medical diagnostic research. In the past decade, as the fields of proteomics and metabolomics have developed as leading techniques for determining biomarkers for disease presence, progression and the monitoring of therapeutic response, CIL has worked closely with industry leaders and researchers to provide the stable isotope-labeled tools needed for improved quantitation and qualification of complex biological systems.

After decades of research, stable isotopes have found their place in an ever expanding commercial scale applications in pharmaceuticals, semiconductors, flat panel displays as well as other high technology fields specifically with deuterium oxide (D2O) and deuterium gases. Pharmaceutical companies have begun to investigate deuteration of molecules that may provide advantages over their existing nondeuterated counterparts. In addition, increasing research into the potential medical advantages of new deuterated drugs is also occurring. In high technology, deuterated organic molecules and deuterium gas are commonly used in the manufacturing of microelectronics and OLEDs, which contribute to the increased lifetime of the devices.

Learn more about us on our website: www.isotope.com