QC Digital System Specialist - Dublin, Ireland - Cpl

Description

Cpl in partnership with our client Pfizer are seeking a QC Digital System Specialist to join the team for an 11 month fixed term contingent contract at their state of the art plant in Grange Castle, Dublin.

Role Description:

The QC Laboratory Digital Systems Specialist will drive modernization and robustness initiatives at the Grange Castle site by working with site stakeholders to understand laboratory system requirements, collaborating with vendors and Digital partners to deliver solutions and processes to maintain operational effectiveness.

The QC Laboratory Digital Systems Specialist will be responsible for adherence to maintenance processes, practices and periodic testing to provide high assurance of continued operations of the critical laboratory systems or speedy recovery of same. The position will work with the Digital Site Services and QC teams, to ensure appropriate and timely engagement of Digital services and tools.

Role Responsibilities:

• Partner with Quality Control management to share the awareness of their role in driving each systems compliance, availability and robustness.
• Engage with the business to identify and define scope for continuous improvement, robustness, and Best Practice initiatives assisting with improving the efficiency of processes and systems on site, while capturing the technical requirements / expectations / deliverables.
• Connect with Global Digital Teams to support global solutions at a site level and provide on-site technical support to stakeholders.
• Drive contemporizing and modernization of computer hardware and operating systems, incorporating better integration with our environment and automated systems.
• Take responsibility for systems joining the correct Network Segments in QC, ensure all systems are on the correct VLAN etc. Advise and deliver process improvement Initiatives.
• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Connect with the Digital Solution Areas, BTAMS, and BTI to ensure the systems and services support provided meets the expectation of the business users. Monitor the service being delivered to the laboratory, follow-up on unsatisfactory support metrics and escalate critical service issues with relevant Digital /BTI teams.
• Work with Information Technology partners to establish development, test and production environments.
• Perform risk analysis and impact assessments when solution integrates with other Pfizer systems.
• Create and implement the application software configuration and systems design for commercial off-the-shelf software products and systems.
• Support Digital Site Services with lockdowns, monitoring and troubleshooting escalation of Labs Workstation requests/tickets as required.
• Support Equipment Validation Team (EVT) on technical planning and issues during validation activities. Hands-on technical liaison with BT, EVT, System Owner and Vendors.
• Define the technical specifications for new systems and provide input to URS.
• Review of User Access, roles and permissions for Laboratory workstations and management of a control framework to support administration activities.
• Investigate virtualization opportunities to resolve aging system issues and implement where required. Ensure completion of technical decommissioning of Workstations (including virtualization if required).
• Ensure correct implementation of Data Integrity tools and manage implementation of DI tools upgrades as required. Maintenance of Workstation Inventory and other required Workstation Management records.
• Engage with Quality Compliance to ensure the right policies and programs are in place to maintain system compliance with cGMP regulations and Pfizer policies and standards.
• Produce regular reports on Labs Computer System Health (Backups, Disaster Recovery, PC wellbeing, User Practices etc.).
• Ensure correct implementation of Digital Tools onto QC systems.

Qualifications

• Bachelor of Computer Science, Engineering or related Technical field required. Minimum of 6 years' + experience in information technology with minimum of 4 years related experience in the pharmaceutical or fine chemical industry.
• Knowledge of Lab systems (LIMS, SAP, TrackWise, PDOCs) an advantage.
• Experience in Data Science field.
• Knowledge of the Information Technology engineering practices
• Demonstrated capabilities and experience collaborating and working effectively in team settings, frequently in virtual teams; embrace diversity; influence stakeholders and build business partnerships to deliver results.
• Quick to establish trust and respect
• Good facilitation, negotiation and presentation skills
• Functional/Technical Knowledge: Applies strong information technology in planning and executing successful systems projects, driving process efficiencies and ability to manage multiple priorities. Knowledge and expertise with the following disciplines desired:
• System Administration
• Software Development Life Cycle methodologies
• GMP, GLP and associated regulatory requirements.

Work Location Assignment: On Premise