Facilities - Calibration Planner

Summary: The Calibration Planner/Scheduler under the supervision of the Facilities Support Supervisor is responsible for the planning, scheduling and performance of the calibration program including the oversight of the Computerized Calibration & Maintenance Management System (CCMS/CMMS) in support of multiple manufacturing facilities such as the National Center for Therapeutic Manufacturing (NCTM), the Texas Biological Facility (TBF) and the Flexible Biological Facility (FBF) on behalf of Fujifilm Diosynth Biotechnology Texas (FDBT). Primary responsibilities include managing the daily calibration operations such as screening of incoming work orders, identification of job requirements, scheduling of calibration staff.  This position will interact with other maintenance and technical trades, such as manufacturing operators, engineers, maintenance technicians, validation, quality and external suppliers in order to provide a high level of excellence over the calibration operational activities of FDBT

External US

Essential Functions:

• Responsible of taking a leadership role in the day to day activities of the Calibration Operations (Planning, Scheduling).
• Responsible for the planning, scheduling and performance of the calibration program.
• Responsible for the oversight of BlueMountain Regulatory Asset Manager (CCMS/CMMS) across multiple facilities.
• Responsible to conduct field walk downs to identify and document job requirements.
• Responsible to make available permits and safety procedures required for the job execution.
• Responsible of calibration standards are available to perform the work schedule.
• Estimate required hours on work order tasks, total work order duration and skills required to perform the task.
• Responsible to work in conjunction with calibration supervisor the schedule of staff for the execution of calibration activities.
• Communicate with technical trades regarding ideas and procedures that would make future jobs more efficient.
• Meet with internal customers in order to plan and schedule calibration activities for their instrumentation across multiple facilities.
• Maintain work load balance across the Metrology Department and monitors department labor utilization.
• Support other team members and system users on issues pertaining to the CCMS/CMMS system.
• Work directly with Manufacturing, Validation, Quality Assurance, Metrology, Maintenance, Facilities, and Quality Control in order to support their individual department needs.
• Responsible for developing, writing, editing and/or reviewing SOPs for the maintenance operations.
• Monitor departmental KPIs in order ensure a high level of efficiency.
• Be able to handle multiple priorities quickly and efficiently, and delegate tasks to appropriate trades and skill levels.
• Demonstrate continuous personal pursuit to increasing job knowledge, proficiency in technical understanding, and problem solving abilities.
• Maintain a positive, professional, and customer oriented attitude.
• All other duties as may be assigned.

Required Skills & Abilities:

• Knowledge of a wide variety of typical calibration tasks and work orders lifecycle. General principles of engineering, operations and the calibration standards and personal protective equipment required to perform many of the daily calibration tasks.
• Strong knowledge of Computerized Calibration & Maintenance Management Systems (CCMS/CMMS), preferably BlueMountain RAM.
• Strong leadership skills, written and verbal communications skills, be self-motivated and possess interpersonal skills.
• Ability to learn quickly and work effectively with little supervision when needed.
• Strong analytical and problem solving skills and experience applying these skills to resolve technical problems. ​
• Ability to coordinate, facilitate and organize resources in an efficient manner.
• Ability to work effectively under extreme pressure to meet deadlines.
• Well organized and detail oriented with ability to handle multiple activities simultaneously.
• Desire to work in a fast paced, state of the art, alternately research and customized manufacturing facility.
• Working knowledge of MS Office products (Word, Excel, Outlook, and PowerPoint).
• Knowledge of cGMP and cGDP requirements and procedures.
• This role will require a high level of personal organizational skills, experience and drive.

Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to:

• Experience prolonged sitting, standing, walking, bending, stooping and stretching.
• Use hand-eye coordination and manual dexterity sufficient to operate portable tools, as well as a computer keyboard, telephone, calculator, and other office equipment is required.
• Have a normal range of vision.
• May be required to lift up to 50 pounds on occasion.
• Climb ladders and stairs of various heights.
• Be exposed to wet or humid conditions.
• This position may include On-Call response for Facility issues.
• Be exposed to outdoor weather conditions.
• Be exposed to noisy environments.
• Attendance is mandatory

Qualifications:

• Bachelor's degree in a related discipline with a minimum of 3 years of overall experience on which at least 2 years must be in a cGMP or other FDA regulated operation; OR
• Associate's degree in a related discipline with a minimum of 5 years of overall experience on which at least 3 years must be in a cGMP or other FDA regulated operation; OR
• High School Diploma with some additional technical education or training in a college or university with a minimum of 7 years of overall experience on which at least 4 years must be in a cGMP or other FDA regulated operation.

Preferred Qualifications:

• Experience working in a biotechnology facility is preferred.
• Experience in Start-Up & Commissioning of cGMP Facility.

 #LI-SB2