Labs & Manufacturing IT Engineer

Key responsibilities and authority

Operations Handling:

• Understands the specific technology needs and challenges within their Manufacturing Operations processes - aligning IT services accordingly.

• Provide on-site technical support for validated applications used in critical Manufacturing processes ensuring alignment with ITQA Quality Assurance Regulatory Affairs teams and compliance with regulatory requirements such as FDA EMA and GxP standards.

• Ensure IT Operations monitors critical Manufacturing Production Systems and Applications to ensure they remain operational and coordinate regular maintenance windows to minimize downtime.

• Maintain critical manufacturing inventory asset data to ensure that accurate reporting can be provided to support incidents audits and projects.

• Acts as the liaison between Manufacturing Operations Leadership Departments (including Production Engineering Maintenance and Quality Assurance) Employees Vendors IT On-site support and Global IT Hubs

• Drive adoption of new and existing systems to ensure business change / value is delivered.

• Educate the wider IT teams on the needs and complexity of their Manufacturing Operations processes.

• Stay up-to-date with Manufacturing Operations industry trends and best practices for application support and technologies.

Major Incidents:

• Supports the incident management team on P1 & P2 incidents which impact Manufacturing Operations; ensuring that the relevant Business Unit/IT Teams/Vendors are engaged to support and reduce downtime arising from incidents.

• Troubleshoot equipment failures or malfunctions on the factory floor including in-process test equipment ruggedized devices industrial PCs and machinery interfaces.

Business Continuity:

• Create and maintain documentation including knowledge articles for; common issues incident resolution best practices for factory-specific IT support user guides and FAQs.

• Participate in the testing and deployment of software updates and patches.

• Drive Manufacturing Excellence; for example leading Business Continuity Planning and continuous-improvement activities

• Oversee and contribute to the management of projects originating from Global IT; providing facilitation and project brokerage to ensure smooth delivery/implementation.

Dotted line to Global manufacturing:

• Collaborate with departmental leaders to identify opportunities for process improvements and innovation through technology feeding ideas generated through to the GQO & R&D IT Business Partners

• Contribute to the demand management process by performing hands on data gathering for alignment of ideation though to the GQO BP and overall GQO/R&D strategies

Vendor Coordination:

• Coordinate the vendor relationships for specialized systems ensuring contract compliance and SLA fulfillment.

• Oversee vendor-led upgrades patches and maintenance to minimize disruptions to business operations.

• Contribute to projects involving system implementations migrations or upgrades at manufacturing and lab sites.

• Participate with cross-functional teams including Regional IT Leads on-site support technicians and external vendors to ensure successful project delivery.

Key requirements

• Fluency in English

• 510 years of overall IT experience

• Minimum 2 years working with validated systems

• Proven excellent communication and interpersonal skills.

• Experience of Manufacturing Operations ideally within MedTech or Pharmaceuticals

• Strong technical proficiency in troubleshooting software issues and providing solutions.

• Strong analytical and problem-solving abilities

• Experience working directly with internal and external customers technical experts and professional staff.

• Previous experience in IT project management with a demonstrated ability to effectively lead successful implementation of IT systems.

• Experience in producing documentation and business requirement documentation.

• Ability to develop and report metrics and KPIs.

• Ability to present complex data and analyses to senior management.

• Ability to work collaboratively with external and internal stakeholders.

• Understanding/certification of ITIL and experience of implementing these standards

• Understanding/certification of BRMP and experience of implementing these standards

• Consultative and continuous-improvement focus

• Ability to work independently and prioritize tasks in a fast-paced environment.

• Familiarity with change control processes and documentation practices in regulated industries

• Strong interpersonal and communication skills to effectively collaborate with business and technical stakeholders.

• Demonstrated ability to manage complex IT systems in manufacturing or lab environments.

• Analytical thinking with a problem-solving mindset to address technical challenges.

• Familiarity with regulatory compliance in a Medtech or similarly regulated environment (e.g. GxP FDA ISO).

Education/ Qualifications

• Bachelors degree in Computer Science Information Systems or a related field.

• Relevant certifications (e.g. ITIL PMP or certifications specific to MES/LIMS systems) are preferred.

• Advanced understanding of validated systems and regulatory compliance (e.g. FDA 21 CFR Part 11).

Travel Requirements

Position may involve up to 5% travel including visits to manufacturing and lab sites within the region and occasional international trips for project-related activities.

Working conditions

• Work environment is hybrid combining remote work with office work.

• Some on-call availability may be to address critical system issues.

Special factors

• Flexibility to work in highly regulated environments with strict compliance and validation requirements.

• Ability to adapt to regional or business unit-specific IT challenges.