Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.
Under general direction, the Senior Automation Engineer will lead the automation, controls, and instrumentation support function for implementing any new automated system, any change to any existing automated system and ensure the integrity of the data generated by automated systems.
The Senior Automation Engineer will provide day to day automation/controls engineering support and Project Management for Engineering Projects for Allergan's Irvine site.
The incumbent must conduct their work activities in compliance with all Allergan internal requirements and with all applicable regulatory requirements. Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
Main Areas of Responsibilities
Manage activities regarding the design, construction, factory acceptance testing, installation and commissioning of all automated facility equipment, and utility systems Provide technical support for the qualification of the pertinent equipment.
Identify, Implement and lead data integrity methodologies for automated systems to ensure absolute reliability of the data that's being generated.
Provide automation/controls engineering support for the site, and act as a liaison between Biologics Manufacturing and Corporate IT for all manufacturing, QC and Facilities controls/automation/data integrity projects.
Implement and Manage all automation/controls/data acquisition projects for the Irvine site. Ensuring that objectives are clearly defined and that project objectives are achieved within budgetary and time constraints.
Manage technology and integration vendors to ensure projects meet specifications and are delivered on time
Initiate and manage systems automation/control/data acquisition continuous improvement initiatives. Be responsible for the defense of the automated systems and all executed protocols and reports during regulatory inspections and internal audits
Provide project management support to the site.
Provide input to the Department Managers on the Annual Capital Strat Plan, and Capital Budget.
Maintain a clean and organized work area.
Assist Allergan in achieving environmental, health, and safety goals by working safely and observing all general plant and department safety policies.
Perform all assigned duties according to departmental SOP's and cGMP's.
Remain current on proper procedures by reviewing current, revised, and new SOP's relating to the job and to the department.
Complete and remain current with all required cGMP and safety training.
Perform all other duties as assigned.
Allergan is a regulated company and the incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.
Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.
Minimum of 5 to 7 years practical engineering experience in a cGMP facility
Strong user of Excel and Microsoft Projects
Knowledge of cGMP's
General understanding of Quality Engineering activities
Detail-oriented and self-motivated