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Senior Calibration Specialist
2 months ago
BioPharma Consulting JAD Group is seeking a detail-oriented Calibration Planner to ensure compliance with industry standards and regulatory requirements.
Key Responsibilities- Lead day-to-day Calibration Operations, including planning and scheduling.
- Oversee the calibration program, ensuring standards are met.
- Manage BlueMountain Regulatory Asset Manager (CCMS/CMMS) across multiple facilities.
- Conduct field walk-downs to identify job requirements.
- Provide necessary permits and safety procedures.
- Ensure calibration standards are available for scheduled work.
- Estimate task hours, duration, and required skills.
- Collaborate with calibration supervisors to schedule staff.
- Communicate with technical trades to improve efficiency.
- Meet with internal customers to plan calibration activities.
- Maintain workload balance and monitor labor utilization.
- Support team members and system users on CCMS/CMMS issues.
- Work with Manufacturing, Validation, Quality Assurance, Metrology, Maintenance, Facilities, and Quality Control to support department needs.
- Develop, write, edit, and review SOPs for maintenance operations.
- Monitor departmental KPIs for efficiency.
- Handle multiple priorities and delegate tasks effectively.
- Continuously pursue job knowledge, technical understanding, and problem-solving abilities.
- Knowledge of calibration tasks and work orders lifecycle.
- Strong understanding of engineering, operations, and calibration standards.
- Experience with Computerized Calibration & Maintenance Management Systems (CCMS/CMMS), preferably BlueMountain RAM.
- Leadership skills, written and verbal communication skills, and self-motivation.
- Ability to learn quickly and work with minimal supervision.
- Strong analytical and problem-solving skills.
- Ability to coordinate resources efficiently.
- Ability to work under pressure to meet deadlines.
- Well-organized and detail-oriented with ability to handle multiple activities.
- Desire to work in a fast-paced, state-of-the-art manufacturing facility.
- Working knowledge of MS Office products.
- Knowledge of cGMP and cGDP requirements and procedures.
- Bachelor's degree in a related discipline with 3 years of experience in a cGMP or FDA regulated operation; OR
- Associate's degree with 5 years of experience in a cGMP or FDA regulated operation; OR
- High School Diploma with additional technical education or training and 7 years of experience in a cGMP or FDA regulated operation.
- Experience working in a biotechnology facility.
- Experience in Start-Up & Commissioning of cGMP Facility.