This position performs as Facilities Engineering investigator and technical writer, with responsibilities in the Maintenance & Calibration related issues and their impact on manufacturing, processes, and equipment systems at the Bioscience Laboratories Irvine facility.
This position will be responsible for:
- Investigation of events within the Facilities Engineering dept. relating to Maintenance and Calibration programs, equipment & utilities systems.
- Support Change Control activities, technical writing of Trackwise records such as deviation investigations, CAPA’s, risk assessments, change controls, action items, in addition to other compliance reports and/or responses to internal & external audits observations as necessary.
- Assist with the vendor qualification programs, assuring quality and service agreements for Facilities vendors are in place.
- Revise department procedures / SOP’s as necessary and as directed by the Facilities Manager.
- Work with other stakeholders and Quality Assurance to determine effective Corrective and Preventive Actions.
- Outline process improvements to increase quality, efficiency, and compliance.
- Support internal / external audits for Facilities Engineering department; coordinate observations responses accordingly.
- Work with training department and assist with department training requirements as necessary.
- Perform other duties as assigned.
- Incumbent must be self-directing and has full authority to make decisions and/or take action that is required to carry out job duties. Abbvie internal requirements include compliance with ethics, environmental health and safety, human resources, cGMP procedures, general business policies, requirements and objectives. The incumbent must be willing to take temporary assignments as required.
Minimum requirements for this position are:
Bachelor’s degree in Engineering or Sciences, or equivalent experience such as a minimum of 5 years of experience in Facilities Engineering / Maintenance / Calibration field in GMP environment.
Experience: IT Systems
Proficient in Microsoft Office
Familiarity with Change Control management process; Trackwise system (or similar system).
Experience working in a GMP regulated environment and compliance.
Essential Knowledge, Skills & Abilities:
- Experience within GMP pharmaceutical environment in Facilities Engineering / Technical / Utilities areas.
- Change Control management, technical writing of Trackwise records such as deviation investigations, CAPA’s, Risk Assessments, Change Controls and Action items.
- Broad understanding of Maintenance and Calibration activities in GMP / regulated Manufacturing environments.
- Demonstrated ability in technical writing and problem solving.
- Broad understanding of department procedures / SOP’s.
- Detail orientated, ability to generate results.
- Effective communication, verbal and in writing.
- Ability to obtain gowning access to the controlled area.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced