- Our client, a globally renowned pharmaceutical company based in County Dublin have a fantastic opportunity for an experienced QC Laboratory Digital Systems Specialist.
- The QC Laboratory Digital Systems Specialist will drive modernization and robustness initiatives at the 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 successful candidate 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 team, to ensure appropriate and timely engagement of Digital services and tools.
- This is an 11-month contract role with strong possibility for extension.
Core Duties and Responsibilities:
- Management and control of laboratory equipment and instrumentation systems administration within the Quality Control (QC) laboratories at the site.
- Responsible for QC laboratory equipment systems periodic audit trail reviews, data process maps, management of data backup, and periodic testing of data restoration.
- Review of User Access, roles and permissions for Laboratory workstations and management of a control framework to support administration activities
- Act as a primary point of contact to support Equipment Validation Team (EVT) on technical planning and issues during validation activities
- Define the technical specifications for new systems and provide input to URS.
- Ownership of all technical issues related to QC systems and liaison with BT, EVT, System Owner and Vendors to resolve.
- 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 company 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.
- 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 company 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.
Minimum Qualifications and Experience:
- Bachelor of Computer Science, Engineering or related Technical field required.
- Minimum of 3 years’ experience in information technology within in the pharmaceutical or relevant GMP manufacturing environment.
- 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; embracing diversity; influencing stakeholders and building 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.
To Apply: Quote – PE22073
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
GC North Valley Business Centre, Cork, T23 KC67, Ireland.
+353 21 2066178
Please note, we do not require agency assistance with this role.