Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
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.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
