Labs and Manufacturing IT Lead

Abouttherole:

The Labs & Manufacturing IT Engineer is responsible for the day to day IT Operational
activities within the Manufacturing an R&D environments, by providing on-site technical
specialized support, monitoring critical production systems and applications, and
maintaining critical inventory to comply with GxP and regulatory standards.

These roles will partner with the GQO & R&D IT Business Partners, Delivery and other
Operational teams to support the prioritisation of day-to-day activities and will need to
have significant knowledge of both IT and the business processes and will support
incident management for manufacturing and R&D operations.

KeyResponsibilities:

Operation’s 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 FAQ’s.

• 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.

Behaviors&Skills&Experience:

• Fluency in English

• Proven excellent communication and interpersonal skills.

• Experience of Manufacturing Operations, ideally within MedTech or Pharmaceuticals

• Proven experience in IT application support

• 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).

Qualifications/Education:

• Bachelor’s degree in Computer Science, Information Systems, or a related field.

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

• 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 required 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.

Employeeperks,benefits:

Company:

Unomedicals.r.o. (memberoftheglobalcompanyConvatec)
Priemyselný park 3
071 01 Michalovce, Slovakia

Email:job-slovakia@convatec.com
Convatec je svetovým výrobcom zdravotníckych produktov|convatecgroup.com|careers.convatec.com

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