Calibration Planner

BioPharma Consulting JAD Group is looking for a detail-oriented Calibration Planner to join our dedicated team. The Calibration Planner will play a crucial role in ensuring that all calibration activities are conducted in compliance with industry standards and regulatory requirements.

RESPONSIBILITIES:

• 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, reviewing SOP's 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.

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.

Requirements

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