Act as the business analysis specialist supporting the Network & Infrastructure Manager, with primary accountability for the monitoring, management and continuous improvement of the organisation's Operational Technology (OT) and laboratory systems landscape.
Monitor, support and provide oversight of OT networks across manufacturing sites, including factory/plant networks, Environmental Management Systems (EMS) and Building Management Systems (BMS), ensuring availability, performance, security and data integrity.
Manage and maintain laboratory networks and regulated laboratory informatics systems, including the Empower Chromatography Data System (CDS) and the Laboratory Information Management System (LIMS), ensuring compliance with GxP and data integrity requirements.
Provide management and oversight of all standalone analytical equipment and instrumentation used within quality control and research laboratories.
Provide management and oversight of equipment and systems related to the organisation's manufacturing processes, ensuring seamless integration between OT, laboratory and enterprise IT environments.
Translate business and operational requirements from manufacturing, quality and laboratory stakeholders into clear system and process specifications.
Support the Network & Infrastructure Manager in strategic planning, risk management and governance relating to OT and laboratory technology systems.
Key Responsibilities and Outputs:
OT Network Monitoring & Management (Factory, EMS & BMS):
Monitor and maintain the health, availability and performance of OT networks across all manufacturing/factory environments.
Oversee Energy Management System (EMS) network connectivity, monitoring dashboards and data reporting.
Oversee Building Management System (BMS) network infrastructure supporting HVAC, environmental monitoring and facility controls.
Identify and escalate OT network anomalies, downtime risks and cybersecurity vulnerabilities.
Liaise with engineering, facilities and manufacturing teams to align OT network requirements with business needs.
Maintain network segmentation and security zoning between OT and corporate IT networks in line with industry best practice (e.g. ISA/IEC 62443, Purdue Model).
Coordinate OT network upgrades, patching schedules and lifecycle management with minimal disruption to production.
Maintain accurate network topology diagrams, asset registers and documentation for all OT networks.
Laboratory Network & Systems Management (Empower CDS & LIMS):
Manage and support the laboratory network infrastructure connecting analytical instruments, servers and workstations.
Administer and support the Empower Chromatography Data System (CDS), including user access, system configuration, data integrity controls and audit trail reviews.
Administer and support the Laboratory Information Management System (LIMS), ensuring accurate sample tracking, workflow configuration and results reporting.
Ensure laboratory systems comply with data integrity (ALCOA+), 21 CFR Part 11, and other applicable GxP requirements.
Coordinate periodic system validation, qualification and change control activities for laboratory systems in conjunction with Quality Assurance.
Manage laboratory system backups, disaster recovery planning and business continuity arrangements.
Provide first- and second-line support to laboratory personnel on Empower CDS, LIMS and related applications.
Standalone Analytical Equipment Oversight:
Maintain an accurate asset register of all standalone analytical equipment (e.g. HPLC, GC, spectrophotometers, balances) across quality control and research laboratories.
Coordinate connectivity, calibration schedules and preventative maintenance planning for standalone analytical instruments in collaboration with laboratory and metrology teams.
Manage software and firmware updates, licensing and vendor support agreements for analytical equipment.
Support qualification (IQ/OQ/PQ) and periodic requalification of analytical instruments from a systems and data perspective.
Investigate and resolve equipment connectivity, data transfer and integration issues between instruments and laboratory systems.
Manufacturing Process Equipment Oversight:
Provide oversight of the network connectivity and systems integration of equipment used in manufacturing processes (e.g. production line controllers, weighing and dispensing systems, packaging line systems).
Support the integration of manufacturing equipment data with OT networks, EMS/BMS platforms and enterprise systems (e.g. ERP, MES) where applicable.
Coordinate with engineering and production teams on equipment upgrades, network changes and system integrations affecting manufacturing processes.
Monitor manufacturing equipment system performance and escalate risks affecting production continuity.
Business Analysis, Governance & Continuous Improvement:
Analyse business and operational information needs across OT, laboratory and manufacturing environments to define system and functional requirements.
Document current and future state business processes, system workflows and key touchpoints across OT and laboratory systems.
Identify opportunities for process improvement, automation and system integration across OT and laboratory environments.
Support project management activities for OT and laboratory systems projects, from requirements gathering through to implementation and handover.
Ensure compliance with internal governance, risk and control requirements, as well as external regulatory and quality standards (GxP, data integrity, information security).
Conduct regular audits and reviews of OT and laboratory systems to verify data accuracy, integrity and security.
Manage relationships with equipment vendors, systems integrators and service providers, including contracts and SLAs relating to OT and laboratory systems.
Prepare and present regular reports on OT network health, laboratory systems performance and equipment status to the Network & Infrastructure Manager and relevant stakeholders.
Provide training, guidance and support to end users on OT and laboratory systems to enhance user experience and system adoption.
Stay abreast of industry trends, emerging technologies and regulatory changes relevant to OT, laboratory and manufacturing systems.
Core Competencies:
Strong understanding of Operational Technology (OT) networks, including factory/plant networks, EMS and BMS.
Sound knowledge of laboratory informatics systems, particularly Empower CDS and LIMS.
In-depth understanding of pharmaceutical/manufacturing industry regulations, GxP, data integrity, and quality assurance standards.
Strong business analysis skills, including requirements gathering, process mapping and systems documentation.
Working knowledge of analytical laboratory equipment and manufacturing process equipment.
Skilled in MS tools, including Excel, PowerBI, Visio and SharePoint.
Strong project management skills, with the ability to manage multiple concurrent OT and laboratory systems initiatives.
Excellent stakeholder management skills, with the ability to engage effectively across IT, OT, laboratory, quality and manufacturing teams.
Excellent facilitation, communication, analytical and problem-solving abilities.
Outstanding planning and organisational skills, with a proven track record of meeting deadlines and objectives.
Ability to translate complex technical, regulatory and compliance concepts for non-technical stakeholders.
Knowledge of network infrastructure, cybersecurity principles and IT/OT convergence.
Vendor and contract management experience, overseeing outsourced service providers and equipment suppliers.
Proactive, detail-oriented and forward-thinking, with a strong focus on data integrity, compliance and continuous improvement.
High degree of integrity and discretion when working with regulated systems and confidential business information.
Requirements
Minimum 5 years' experience in a Business Analyst, Systems Analyst, or similar role within a manufacturing, pharmaceutical, or other regulated industrial environment.
Proven experience working with Operational Technology (OT) environments, including SCADA, PLC, EMS and/or BMS systems.
Proven experience with laboratory informatics systems such as Empower CDS, LIMS, or equivalent chromatography data and laboratory management systems.
Formal Business Analysis certification (e.g. CBAP, CCBA, ECBA, or equivalent) advantageous.
Knowledge of GxP, data integrity principles (ALCOA+), 21 CFR Part 11, and computer system validation (CSV/GAMP 5) within a pharmaceutical manufacturing context advantageous.
Sound understanding of IT/OT convergence, network segmentation, and industrial cybersecurity principles.