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AbbVie Manufacturing BTS Manager, IT in Waco, Texas

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Take the next step in your career with an organization that strategically invests in the long-term health of technology and its people. The AbbVie Business Solutions (BTS) team shapes the digital transformation necessary for our treatments to positively impact in the role of Manufacturing BTS Manager, IT, you’ll tackle complex you develop and diversify your professional experiences helping others grow and develop their skills.

Purpose:

The Manufacturing BTS Manager, IT position is focused on providing system administration, day to day support, and lifecycle management for the critical applications required by IME and manufacturing operations teams. The Role is required to maintain application health, system security and performance, data availability and compliance to site and IME Operations: including but not limited to POMS, OSI PI, Antares, SmartFactory across manufacturing processes business units. This role requires working closely with business stakeholders as well as BTS colleagues in Infrastructure, Quality and Information Security. The candidate is expected work closely with key stakeholders from operations, technical services, and Quality to support level 3 application triage, root cause problem solving and CAPA.

In this role you’ll be responsible for:

  • Work on AbbVie IT manufacturing systems and application projects.

  • Is responsible for the implementation and rollout of new IT systems.

  • Act as the site escalation point for customer impacting priority incidents relating to the security, performance and availability of manufacturing IT applications and data.

  • Ensure that relevant Manufacturing IT Applications are maintained with appropriate end point security, operating system updates and application hotfixes.

  • Act as the site BTS Application SME for internal Audits and Regulatory Inspections (FDA, HPRA, LNE, etc.)

  • Ensure regulatory and procedural requirements are met in relation to periodic audit trail reviews, access provisioning and account re-certification.

  • Ensure lifecycle activities including system upgrade, configuration change, CAPA/RCA investigation, and system retirement are performed in compliance with local QA and global BTS policy/procedures.

  • Continuous improvement in pursuit of site stability and ensuring minimal negative impact on OEE and manufacturing volume output.

  • Attend site TRT review as Application SME – as required per IT10.

  • Support for Root Cause problem solving initiatives and provide information to progress investigations specific to non-conformances associated with manufacturing application software and data systems.

  • Create technical documents required to complete SDLC document set and support development and maintenance knowledge articles, review and approve of training material, knowledge articles and work aids associated with system support.

  • Provide advanced technical support/guidance to OPS support teams to ensure timely response and recovery from “system down” events.

  • Drive to best-in-class Business Continuity Planning and Disaster Response and System recovery.

Qualifications

Experiences that make you a strong candidate for this role:

Required

  • Bachelor's Degree with 6 years experience OR Masters Degree with 5 years experience OR PhD with 0 years experience.

  • 3+ years’ experience working in a fast, high-octane application support environment

  • OSI PI Administration or relevant Data Historian Administration

  • POMSnet Administration or relevant MES system Administration

  • Microsoft O365 PowerApps / PowerBi

  • Strong analytical skills and a proven ability to problem solve and identify CAPAs for deviations relating to multi-tiered software architecture.

  • Motivated self-starter who is comfortable working in an individual or team-based capacity to achieve departmental and project goals.

  • Excellent verbal and written communication skills

Beneficial

  • Work experience in the pharmaceutical and/or medical device industries

  • Antares serialization management platform (Desirable)

  • Project Management (Desirable)

  • System Admin Windows 10 and Windows 2012/2016/2019/2022 Server

  • Expertise in LAN/WAN segmentation, AD admin and web services XML/XSL -desirable.

  • ITIL (Desirable)

  • GAMP (Desirable

Additional Information

Tools and skills you will use in this role:

  • Position involves working closely with several different departments internally as well as outside sites to resolve Lab Systems IT issues.

  • The position also requires proven problem-solving skills under pressure. The position requires detailed evaluation of several viable solutions to each problem.

  • Requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis.

  • Requires a very high level of attention to detail and mental concentration, to always ensure accuracy and total compliance with procedures.

  • Must be results driven striving to meet all targets and metric standards as set by site/department and division leaders. Understands and supports the principles of Perfect Index Performance metrics.

  • Requires total commitment to quality and always maintaining a high standard of work.

  • Strong interpersonal skills are required.

  • Always demonstrates the highest levels of integrity and a strong work ethic.

  • Strong communication skills, both verbal and written, are required for the execution of this role.

  • Apply advanced technical knowledge and experience to the solution of a broad array of technical problems

Ownership/Accountability:

  • The position has a high level of autonomy and a the person in this position is expected to work on their own initiative.

  • Shows a high level of tenacity to ensure closure of issues.

  • Develops Manufacturing IT System procedures to provide best value for the site.

  • Completes all changes and updates with product and employee safety in mind.

  • Maintains systems in line with the latest guidelines on system and software integrity and validation.

  • Always demonstrates an ethos of Right First Time.

  • Adheres to and follows all procedures, policies and guidelines ensuring compliance with cGMP and HPRA/FDA regulations and company policies, procedures, and guidelines.

Influence/Leadership:

  • Might be required to lead Cross Functional Teams Continuous Improvement projects.

  • Develops and maintains close relationships with key stakeholders in Manufacturing, engineering, quality. Validation, information security and global infrastructure.

  • Provide technical leadership to functional areas and collaborates with key stakeholders.

  • Leadership of initiatives / process improvements in collaboration with interconnecting functions such as Laboratory, BTS, validation, and QA to ensure overall performance achievements and improvements within the department.

Decision Making/Impact:

  • Expected to provide functional expertise to support daily operations and ensure prompt decisions on technical issues.

  • Seeks Managers input when making decisions which affect the area

Why Business Technology Solutions

For anyone who wants to use technology and data to make a difference in people’s lives, shape the digital transformation of a leading

biopharmaceutical company, and secure sustainable career growth within a diverse, global team: we’re ready for you.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​

  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

  • This job is eligible to participate in our short-term incentive programs. ​

Note: No amount of pay is a considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.

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