Purpose:
- Assist CAL lead and supervises 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
Major Responsibilities:
- 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 & assist CAL lead in addressing deviations variance and OOT investigations where needed
Qualifications :
- A technical degree in a related discipline of Engineering
- At least 4-6 years of relevant calibration engineering work experience
- Knowledge of cGMP is preferred
- Working experience in a pharmaceutical / biotech facility
- Prior experience in start-ups commissioning & qualification is a plus
- Excellent leadership and communication skills
- Ability to mentor and coach teammates including external contractors
- Excellent team player willing to work for the common goal
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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Work :
No
Employment Type :
Full-time