Allergan Senior Automation Engineer in Irvine, California

Senior Automation Engineer

Irvine, California, United States at https://agn.referrals.selectminds.com/jobs/6522/other-jobs-matching/location-only

Sep 04, 2018Post Date

183070Requisition #

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.

Position Overview

Under general direction this position will lead the automation, controls, and instrumentation support function for implementing any new automated system, any change to any existing automated system, ensure the integrity of the data generated by automated systems.

Provide day to day automation/controls engineering support and Project Management for Engineering Projects for all of Biologics Manufacturing.

Main Areas of Responsibilities:

  • Oversee , and coordinate activities regarding the design, construction, factory acceptance testing, installation and commissioning of all automated manufacturing, lab, and facility equipment.

  • 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 Biologics Manufacturing, 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 Biologics Manufacturing.

  • 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.

Requirements:

  • Knowledge of FDA, EU, and global GMP’s including Good Automated Manufacturing Practices,

  • 21 CFR Part 11, and EU cGMP Annex 11.

  • Knowledge of Data Integrity Requirements for FDA, EU, and global regulatory authorities.

  • Ability to meet deadlines

  • Ability to take initiative and make decisions within department/company guidelines

  • Ability to demonstrate leadership in job performance

  • Ability to establish and maintain moderately complex documentation systems

  • Ability to communicate effectively

  • Ability to accurately perform detail oriented work

  • Ability to function in a regulated environment and handle confidential information

  • Ability to use a broad range of software used in the Pharmaceutical industry (e.g. MS Office applications, MS Project, MS Visio, AutoCAD, SAP, etc.

  • Extensive knowledge of systems automation, and instrumentation.

  • Extensive knowledge Allen Bradley PLC’s including RSview, RSlink, Factory Talk applications

  • General knowledge of electrical engineering codes and standards.

Education and Experience

  • Bachelor of Science Degree in Mechanical or Electrical/Electronic Engineering or other related field required.

  • 5 to 7 years practical experience as an engineer in a cGMP facility, or equivalent training and years of experience.

Equal Employment Opportunity Employer

Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.