BTS Manufacturing Systems Specialist

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Purpose

• Provide reliable, compliant and secure support for site manufacturing, laboratory and quality systems.

• Act as a technical partner to Manufacturing, Quality, Engineering, Automation and global BTS teams, translating operational needs into sustainable system solutions.

• Maintain manufacturing systems in a validated and supported state throughout their lifecycle, with a focus on business continuity, data integrity, cybersecurity and minimal production downtime.

• Other duties as assigned.

Key Responsibilities

• Provide day-to-day support, administration and lifecycle management for assigned manufacturing and laboratory IT systems, applications, servers and data interfaces.

• Triage incidents and service requests, perform structured troubleshooting and root cause analysis, coordinate vendors and global support teams, and escalate where required.

• Plan and execute controlled system changes, upgrades, patches, configuration updates and obsolescence remediation in accordance with site change control and computer system lifecycle requirements.

• Prepare, review and maintain system documentation, including SOPs, work instructions, system inventories, data flow or process maps, access records, backup evidence, periodic reviews and validation deliverables.

• Support computer system validation and qualification activities, including requirements, risk assessments, test protocols/scripts, traceability, deviations and summary reports, as applicable.

• Administer or coordinate system access and periodic access reviews, ensuring least-privilege access and appropriate segregation of duties.

• Monitor system health, capacity, interfaces, backups and recovery readiness; support business continuity and disaster recovery tests for assigned systems.

• Maintain accurate application, server and asset information in approved repositories and identify lifecycle, compliance, availability and cybersecurity risks.

• Participate in capital projects and new technology introductions from requirements and design through implementation, validation, handover and steady-state support.

• Provide technical input to investigations, CAPAs, audit responses and inspection readiness activities relating to manufacturing systems.

• Deliver user guidance and training for supported systems and promote effective adoption of standard processes and digital solutions.

• Identify and implement continuous improvement opportunities that increase reliability, efficiency, data visibility and operational value.

Technical/Business Knowledge - Job Skills/Experience Required

• Experience with manufacturing or laboratory systems such as MES, ERP/SAP, data historians, LIMS, instrument software, databases, Windows servers and system interfaces.

• Working knowledge of computer system lifecycle, validation, data integrity, access management, backup/restore, change control, incident/problem management and disaster recovery.

• Ability to create clear technical documentation and execute work in accordance with approved procedures and good documentation practices.

• Understanding of infrastructure, networking, endpoint, database and cybersecurity concepts sufficient to coordinate specialist support teams.

• Ability to manage multiple priorities while protecting safe, compliant and continuous manufacturing operations.

Cognitive Skills

• Strong analytical troubleshooting, risk assessment and structured problem-solving skills.

• Good judgement, attention to detail and the ability to communicate complex technical information clearly to technical and non-technical stakeholders.

• Ability to learn quickly, work across functions and balance immediate operational needs with long-term system sustainability.

Ownership/Accountability

• Demonstrates personal responsibility for quality, compliance, safety, data integrity and timely closure of assigned actions.

• Works with appropriate autonomy, maintains accurate records, raises risks early and follows issues through to effective resolution.

• Ensures assigned systems remain supportable, appropriately documented and aligned with approved standards.

Influence/Leadership

• Builds effective working relationships across BTS, Manufacturing, Quality, Engineering, Automation, vendors and global service teams.

• Provides technical guidance, leads or supports cross-functional workstreams, and constructively challenges solutions that introduce unacceptable risk.

• Promotes standardization, continuous improvement, knowledge sharing and a positive service culture.

Decision Making/Impact

• Assesses technical, quality, cybersecurity, business continuity and operational impacts before recommending or implementing changes.

• Prioritizes incidents and work based on patient, product, compliance, safety and production impact, escalating significant risks promptly.

• Decisions can directly affect system availability, data integrity, regulatory compliance and continuity of manufacturing or laboratory operations.

Supervision Received

• Reports to the BTS ME&C Site Lead, who defines objectives, priorities and required governance.

• Performance and development are reviewed through regular one-to-one meetings and the company performance process.

Supervision Provided

• No direct reports unless assigned separately. May coordinate vendors, contractors, project resources or technical workstreams.

Essential Requirements

• Bachelor degree (NFQ Level 7 or 8) in Information Technology, Computer Science, Engineering, Automation or a related technical discipline, or equivalent relevant experience.

• Demonstrated experience supporting computerized systems in a regulated manufacturing, laboratory or life sciences environment.

Desired Requirements

• Knowledge of pharmaceutical or medical device manufacturing and applicable GxP expectations.

• Formal training or certification in IT service management, project delivery, cybersecurity, computer system validation or a relevant technology platform.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

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