Job Description

• Assist the Calibration Lead and supervise a team of external and internal calibration personnel to perform verification and checks on field instruments and devices
• Responsible for all content related to Calibration Job Plans and data in the Computerized Maintenance Management System
• Key stakeholder in the CMMS for Common, API and Biotech facilities
• Assist to analyze trends and identify issues and improvement opportunities proactively
• Assign and schedule Calibration work orders and requests for support
• Ensure all calibration work is performed in compliance to approved SOPs and to cGMP standards. This includes timely follow up of work orders, change controls, investigation reports and deviations
• Assist in review of calibration documentation including test methods, SOPs, PURs and calibration data sheets
• Review and approve content of work orders, upon completion for compliance with GMP and technical accuracy
• Assist as key technical resource for troubleshooting of all instruments in the facility.
• Ensures reference standards are always kept in a valid calibrated state
• Follow up on Calibration work order status and obtain additional resources as required
• Work with the other engineering personnel to improve how equipment troubleshooting is performed
• Evaluate current systems and procedures, develop alternatives, and recommend implementation plans to ensure that work systems support both business and regulatory requirements
• Supervise Calibration Specialists responsible for supporting manufacturing unit operations
• To provide support to ongoing plant operations on an On-call basis beyond working hours and ensure total compliance to cGMP and safety standards but with minimal downtime to equipment and systems
• Schedule availability of Calibration personnel to ensure 7 days 24-hour coverage (on site and on call)
• Develop and assist to implement training programs for Calibration staff
• Support Capital Engineering by completing projects requiring instrumentation calibration and or change control support
• Assist the Calibration Lead in development of appropriate KPIs towards Maintenance Excellence
• Participate and assist the Calibration Lead in addressing deviations, variance and OOT investigations where needed
• Any other duties as assigned by the Supervisor / Manager

• Diploma or Degree in related discipline of Engineering
• At least 3-4 years of relevant work experience
• Knowledge of cGMP is preferred
• Working experience in a pharmaceutical / biotech facility
• Experience in start-ups, commissioning & qualification is a plus
• Excellent leadership and communication skills
• Ability to lead teams including external contractors
• Mentoring and coaching skills
• Excellent team player willing to work for the common goal