AbbVie

Sr. Automation Engineer

Employer
AbbVie
Location
Irvine, California
Posted
May 26, 2021
Ref
2108213
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Under general direction, of the Senior Engineering Manager, the Sr. Automation Engineer will manage and lead the automation, instrumentation, and controls support function for within the cGMP manufacturing operations group at Bioscience Laboratories Irvine, to support continuous improvement and best in class operational excellence capability. The role includes administrative ownership and oversight of new and existing automated systems ensuring that the integrity of the data generated by automated systems is compliant with all relevant cGMPs and continuously maintained.

The candidate must conduct their work activities in compliance with all AbbVie internal requirements and with all applicable regulatory requirements.  AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, general business policies, requirements and objectives.

The Senior Automation Engineer shall provide day to day automation/controls engineering subject matter expertise, support, and Project Management for Engineering department projects for Abbvie Bioscience Laboratory Irvine (BLI) manufacturing operations. Which include the following:

  • Adhere to all regulatory SOPs including Global Quality and Engineering SOPs.
  • Design and implement process automation systems and solutions, to control and optimize bio/pharmaceutical manufacturing operations.
  • Drive Department Objectives by coordinating with all stakeholders, including (Operations General Manager, Quality Assurance, Quality Control, Validation, Facilities, Manufacturing, and Business Technology Services (IT/IS).
  • Ensure cGMP compliant performance of the Supervisory Monitoring System (SMS), Building Management System (BMS), Process Control System (PCS), Manufacturing execution Systems Interfaces (Equipment HMIs) and Process Data Historians.

Major Responsibilities:

  • Assist Allergan in achieving environmental, health, and safety goals by working safely and observing all general plant and department safety policies.
  • Provide input to the Department Managers on the Long Range Planning / Annual Capital Strategy Plan, and Capital Budget.
  • Initiate and manage continuous improvement methodology and devise automation solutions/strategies that improve productivity, business operations and safety/quality standards.
  • Provide project management support for 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
  • 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.
  • Initiate and manage changes/updates to the SMS including (Physical Hardware, Virtual Servers, Process Data Historians) Implementation, maintenance, and Troubleshooting
  • Provide Automation Systems training to Automation Engineers, and end users on process automation.
  • Be responsible for the defense of the automated systems and all executed protocols and reports during regulatory inspections and internal audits.
  • Ensure the reliability and performance of automation system, proactively address potential safety and quality issues, regularly review and address frequent occurring alarms.
  • Participate or lead quality or safety investigations and implement any automation solutions resultant from these investigations.
  • Automation representative in capital projects involving facilities, utilities, equipment and system integration.
  • Commission and Validate new systems and changes to existing systems. 
  • Develop, revise and review SOPs as needed.
  • Audit and update existing system documentation and procedures
  • Monitor and maintain automation systems and ensure system operations are optimized.
  • Ensure periodic preventive maintenance of automation systems are carried out and perform periodic review of automation systems.
  • Complete and remain current with all required cGMP and safety training.
  • Perform all other duties as assigned.

 


Qualifications

Qualifications
B.S degree in Engineering or substantiated 6 to 10 years of equivalent experience in relevant experience in Control Systems especially Allen Bradley, iFix, OSI PI, Siemens etc., preferably in cGMP Bio/Pharmaceuticals.

  • Understanding of Quality Engineering activities.
  • Good interpersonal and communication skills.
  • Detail oriented
  • Ability to multitask
  • Reliability, responsibility, and personal integrity
  • Must be a U.S. citizen or able to provide proof of ability to work in the United States.
  • PMP or CAPM certification preffered

 

AbbVie 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.

 


Significant Work Activities
N/A
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.