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About AbbVie

AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world.  For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.​

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Business Systems Consultant

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Information Technology
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2000247 Requisition #
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Business Systems Consultant will ensure solutions delivered by the IT department comply with 21 CFR Part 11, 68, 210/211 and other regulations and best practices within the pharmaceutical/biotech industry. This individual will be involved with designing and implementing GxP Lab systems working closely with Business Partners.  The Technical Lead will need to follow established change control processes while supporting Lab applications.

 

The IT R&D Lab Application Technical Lead will be a valuable member of the Laboratory and IT teams.  They will recommend improvements to current-state and be responsible for implementing solutions that meet the future-state requirements. In addition to supporting the Labs, the IT R&D Lab Application Technical Lead will also contribute to driving innovation and seeking new technical solutions for R&D.

 

The goal of the Lab Support team is to ensure that lab systems are online and available for use by the Business.  This role has an emphasis on systems administration for client/server systems, including: system design, client/server hardware & software installation, ports/protocols/firewalls, networking, and troubleshooting.  In addition, this role will require appropriate skills to document the current/future state for systems and transferring these systems to operational support by the Tier 1/2 teams.

 

Core Responsibilities:

 

  • Senior System Administrator for GxP Lab Applications such as Empower, OpenLab, Omnic, Insight, SLIM, Vaisala, and other similarly classified applications.
  • Lead a team of System Administrators and coordinate operational activities with the Managed Services team responsible for daily support of these applications.
  • Will be the Technical Lead for the lab team as an escalation point for technical issues that require advanced understanding of Windows Systems Administration techniques and best practices.
  • Technical Lead for Computer System Validation projects for GxP Lab Applications.
  • Will be an active part of the lab support team, but as Technical Lead, they will have the authority to delegate tasks within the team as needed.
  • Provide backup support and guidance to System Administrators on an as needed basis.
  • Will create recommendations, project plans, budgets, and reports for continuous improvement of laboratory systems support.
  • Will work closely with lab support team and vendors to install new systems.
  • Will assist with architecture design for new systems and applications. 
  • Will assist with upgrading systems OS, apps, and related technology (switches, UPS, etc.)
  • Will evaluate lab systems and recommend path to upgrade to ensure systems are under warranty and/or support.
  • Will have a solid understanding of networking, security, databases, applications, and development.  With a stronger than average skill set in at least one of those areas.
  • Will be responsible for routinely creating and presenting proposed Changes to the Change Review Board. 
  • Will support lab customers by using ServiceNow to respond to incidents and requests.  Will routinely review all tickets resolved by the team to ensure they are accurate and complete.
  • Will follow established policies and procedures.
  • Will create content for Knowledge Articles, SOP's, Policies, Work Instructions, etc.
  • Familiarity or experience with laboratory data management platforms such as electronic lab notebook and results & analysis platforms (e.g. STARLIMS).
  • Oversight of Laboratory Systems requirements and configuration definition.
  • Ability to support critical Lab Application such as Waters Empower CDS.
  • Ability to review and update policies, guidelines, and procedures relating to computer system validation.
  • System Administration in a regulated environment with appropriate Change Management processes.
  • Ability to develop solutions to complex problems that require a high degree of ingenuity, creativity, and innovation within the boundaries of industry (e.g. compliance with regulations).
  • Process mapping to identify and recommend business process improvements.
  • Assisting in solutions identification, evaluation, selection, implementation, testing, and working with the IT technical delivery team(s) to meet business requirements.
  • Knowledge of validation lifecycle of lab GxP computerized systems.
  • Prepare, execute, and finalize the validation of computerized systems to be used in the production or development of pharmaceutical products.
  • Assist with GxP and Non-GxP system configuration and general IT duties as needed.
  • Assist in Lab Expansion projects; work with designated teams during Regulatory (and Internal) Audits and Inspections.
  • May be required to travel (approximately 5-10%). 

 

With core competency focused in:

 

  • Leadership capability focusing on relationship management, influencing decision making and resolving conflicts.
  • Strong core IT fundamentals background accompanied with knowledge of information systems & workflows for lab assay data & knowledge management, data query & analysis, lab automation & LIMS, sample management, bio banking, and inventory.
  • Familiar working in a Research & Development lab (or similar) to ensure safe operation when working around chemical and biological hazards.  Proper Protective Equipment and lab safety guidelines are followed at all times.
  • Install, configure, and maintain computer systems in compliance with relevant policies, guidelines, and procedures.
  • Coordinate downtimes for project related upgrades, updates, and configuration changes.

 

Skills:

 

  • The IT R&D Lab Application Manager shall partner with Business Owners/SME’s, Business QA, IT Compliance and end users with differing levels of technical expertise.
  • Ability to take projects from design to long-term maintenance.
  • Excellent communication and documentation skills.
  • Good presentation skills to clearly communicate technical concepts with a high degree of precision to technical audiences.  Ability to explain complex concepts in simpler terms for other audiences as needed.
  • Expected to deliver documentation and training with all solutions.
  • Ability to plan and coordinate multiple simultaneous application efforts.
  • Quick learner, self-starter, tenacious problem solver, and highly motivated.
  • Advance understanding of Microsoft Windows 7, 10 and Server 2008 R2, 2012, 2016
  • PowerShell fundamentals
  • Citrix fundamentals
  • System Administration, Management, and Automation
  • Writing, reviewing, and executing validation documents within the Computerized System Validation framework.
  • GxP Lab and instrumentation support background and experience.
  • Experience with automation, scripting, and development
  • Familiar with drug discovery, translational medicine, and the IND/NDA process.
  • Familiar with electronic ticketing and document management systems such as: ServiceNOW, MasterControl, and Trackwise.
  • Computer System Validation and the Change Control Process in Life sciences industry.
  • Advanced user of Office and other productivity applications: Access, Word, Excel, PowerPoint, Outlook, InfoPath, Project, SharePoint, SmartSheet, PowerBI, etc.

 

 

 

  • Bachelors Degree or an equivalent combination of education and work experience.
  • 10-12 years of related work experience.
  • Exercises latitude in the approach to problem solving.
  • Determines and develops approach and solutions to problem.
  • Working knowledge of 21 CFR Part 11, 68, 210, 211; Computer Systems Validation and GAMP framework.  Must understand these regulations and be able to deliver compliant solutions.

 

 

Equal Employment Opportunity Employer

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.

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