Maintenance & Calibration Coordinator

Description

Position Summary:

The Maintenance & Calibration Coordinator is responsible for the coordination of all corrective maintenance, preventive maintenance, and calibration activities at Bell International Laboratories. The role requires a strong technical and quality background in the pharmaceutical and/or personal care industry. The successful candidate will work cross-functionally with Quality Assurance, Quality Control, and Production teams to support new and ongoing maintenance and calibration initiatives.

Requirements

Responsibilities

• Maintenance & Calibration Programs:
• Maintain, enhance, and execute the Preventive Maintenance program.  
• Work with SMEs to write and/or enhance preventive maintenance procedures.
• Maintain, enhance, and execute the Corrective Maintenance Work Order program.
• Maintain, enhance, and execute the Calibration program.
• Work with and schedule external calibration suppliers.
• General:
• Develop, update, maintain SOPs and provide training as appropriate.
• Ensure maintenance and calibration activities comply with regulatory requirements (e.g., FDA, OTC monographs) and internal quality standards.
• Support quality assurance initiatives by participating in audits and implementing corrective actions as necessary.

Required Skills/Abilities

• Working knowledge or background in the pharmaceutical and/or personal care industry.
• Working knowledge of industry best practices for corrective and preventive maintenance.
• Working knowledge of industry best practices for instrument calibrations.
• Strong technical and/or regulatory expertise.
• Detailed record keeping and communication of results to others.
• Project skills appropriate for leadership of validation projects.
• Excellent written, verbal, and interpersonal communication skills.
• High level of initiative, innovation, critical thinking, and problem-solving skills
• Ability to work cross-functionally & at all levels within the organization including senior leadership.
• Ability to prioritize multiple responsibilities and manage deadlines accordingly.
• Communicate effectively and professionally both internally and externally.
• Exceptional attention to detail and high level of accuracy & organization.
• Ability to work as part of a team and excel independently in fast-paced environment.
• Ability to adapt quickly to changing circumstances.
• Demonstrated leadership skills.
• Proficient with Microsoft Office.

Required Education and Experience

• Highschool diploma or GED.
• Minimum of 3+ years of experience in pharmaceutical and/or personal care industry, with at least 2 years of experience with the coordination of maintenance and calibration activities.
• Knowledge of cGMP, FDA regulations, and OTC compliance standards.

Preferred Education and Experience

• Associate’s or Bachelor’s Degree (preferred)
• Lean Six Sigma certification (Green Belt or higher) is a plus.

Physical Demands

• Must be able to lift up to 20 pounds on a regular basis.
• Ability to wear Personal Protective Equipment including a respirator, gloves and eye protection.
• Ability to perform work in a manufacturing environment where there is exposure to occupational hazards.

EEO Statement

Bell International Laboratories provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. 

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.