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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.

BTS Site Technical Lead

Irvine, California Req ID 2207517 Category Information Technology Division AbbVie

 

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 TwitterFacebookInstagramYouTube and LinkedIn.

 

Purpose:

This is an excellent opportunity to develop and advance your career while working in a proactive and motivating team environment. This role affords you the opportunity to prove your leadership skills in an emerging area critical to the success of entire organization.

 

The BTS Site Technical Lead role in BLI, Irvine CA is critical to success of overall manufacturing operations by ensuring that IT systems and processes are maintained, compliant, secure and enable efficient and effective operations. A successful candidate will provide end-to-end technical solution leadership and business process alignment through the delivery and maintaining of Manufacturing and Lab Operational Information and liaise with Automation systems. The role will liaise with Global/Enterprise applications and Infrastructure services team ensuring successful delivery of the site’s infrastructure information systems. This role also advocates on behalf of business stakeholders to ensure IT services meet their business priorities and needs, while improving operations and executing projects in a fast paced, multi-disciplined, cross-functional team environment. This role includes a hands-on technical component to build, deploy, manage, and support manufacturing and laboratory GxP systems, as well as site infrastructure.

                                 

Responsibilities:

 

  • Provide technical expertise and day to day technical support to control systems, lab systems OT and IT systems. Responsibilities include adhering to change control/management, configuration control, compliance to system/data security policies and data integrity, patching, upgrades, backups, validation and qualification support, and user administration/management.
  • Provide expert guidance on new technologies and emerging IT & automation trends for process and business reengineering.
  • Liaise with Global Enterprise, Infrastructure and Quality system teams ensuring high standards of service delivery and engage to influence continuous improvement opportunities for site operations.
  • Ensure successful integration milestones are achieved while minimizing business impact and disruption of manufacturing operations.
  • Ensure security, compliance and data integrity regulatory standards are maintained across all site technology systems.
  • Support and provide domain expertise to site on GxP, data integrity, data Security as well as internal & external audits.
  • Facilitate internal resources and outside vendors in developing technical solutions for manufacturing and laboratory systems. Interface with equipment vendors to ensure successful machine delivery, integration, and manufacturing validation.
  • Support product, platform, and cost improvement programs by delivering qualified systems and acquisition software, machine controls and PLC/SCADA software. Interface with SQA, QA and Operations groups to successfully validate software systems.
  • Generate & Maintain documentation (SOP’s & Technical Documentation) for full GMP validation and operation, including documentation of changes made.
  • Contribute to the Automation & IT Business Strategy
  • 10% required travel between Bioscience Laboratories, Campbell (BSL) and Bioscience Laboratories, Irvine (BLI) locations.
Qualifications:
  • Bachelor's Degree with 7 years’ experience; Master's Degree with 6 years’ experience; PhD with 2 years’ experience.
  • Exposure to FDA, HPRA, GMP, 21CFR11, safety and environmental legislation (Experience in the pharmaceutical industry preferred)
  • 3+ years proven track record in delivering IT & automation solutions in similar environment
  • 3+ years + project management experience – proven record of cross functional project delivery
  • Systems background: ERP, SAP, Maximo, RAM, MES, Data Historian (OSI PI), Chromatography (Empower) and laboratory management systems (NuGenesis, Acronis) SCADA/DCS an advantage
  • Knowledge of Quality Assurance, SLC, Compliance and Data Integrity
  • Ability to manage and support manufacturing layer Infrastructure in conjunction with global teams
  • Clarity of vision and courage of conviction to make good decisions
  • Ability to influence key stakeholders at site and global level in the company
  • Exercises latitude in the approach to problem solving.
  • Determines and develops approach and solutions to problem.
  • Broad knowledge of MS operating system, including server roles: AD, DNS, Virtualization, Remote Desktop, etc.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 10 % of the Time
Job Type: Experienced
Schedule: Full-time
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