Role title: IT Application Support Engineer
Key Responsibilities
1. Application Support & Maintenance
o Monitor and maintain pharmaceutical applications to ensure optimal
performance and availability.
o Perform regular system health checks and proactive maintenance.
o Apply patches, updates, and upgrades to applications as needed.
2. Hardware and Software Maintenance:
o Install, configure, and maintain computer systems, printers, and other peripherals.
3. Help Desk Support:
o Respond to user inquiries and provide technical support via phone, email, or inperson.
o Troubleshoot application errors and work with development teams to
implement fixes.
o Diagnose and resolve hardware, software, and network issues promptly.
o Provide timely and clear communication to end-users regarding the status of their
requests.
o Log and track support requests using a ticketing system.
o Document incidents, problems, and resolutions for future reference.
4. System Administration:
o Administer and maintain enterprise-level systems and applications.
o Implement and manage Active Directory, user accounts, and group policies.
o Perform regular system backups and ensure disaster recovery procedures are in
place.
o Support with provision and review where applicable of Audit Trails for system
owners to review.
5. User Assistance & Training
o Provide technical support and training to end-users on application
functionalities and best practices.
o Develop user guides, training materials, and documentation to assist users.
6. Collaboration & Communication
o Work closely with cross-functional teams including IT, development, QA, and
vendors to resolve application issues.
o Communicate effectively with stakeholders to keep them informed of issue
status and resolutions.
7. Compliance & Security
o Ensure applications comply with regulatory requirements and industry
standards (e.g., FDA, GMP, SOX).
o Implement and maintain security protocols to protect sensitive data.
8. Performance Optimization
o Analyze application performance and implement improvements to enhance
efficiency and user experience.
o Conduct regular reviews and assessments to identify areas for optimization.
9. Project Involvement
o Participate in application-related projects, including new implementations,
upgrades, and migrations.
o Assist in requirement gathering, testing, and deployment phases.
10. Electronic System Implementation:
o Project Manage the delivery of electronic systems, inc requirements gathering,
scheduling, budgeting.
o Develop and execute validation protocols (IQ, OQ, PQ) for GxP systems to ensure
compliance with regulatory requirements.
11. Reporting & Documentation
o Generate and analyze reports on application performance and usage.
o Maintain detailed and accurate documentation of support activities,
configurations, and processes.
12. Audit Support:
a) Prepare for and participate in regulatory inspections and audits.
b) Address findings and implement corrective and preventive actions (CAPAs) as
needed.
Qualifications
• Education: Bachelor’s degree in Computer Science, Information Technology, or related
field.
• Experience:
o Minimum of 3-5 years of experience in application support, preferably in the
pharmaceutical or healthcare industry.
o Experience with pharmaceutical applications such as LIMS, ERP, CRM, or
specific pharma software.
• Technical Skills:
o Proficiency in SQL, database management, and scripting languages.
o Familiarity with application servers, web servers, and middleware technologies.
o Knowledge of pharmaceutical regulatory requirements and validation
processes.
• Soft Skills:
o Strong problem-solving and analytical skills.
o Excellent communication and interpersonal skills.
o Ability to work independently and as part of a team.
• Certifications (Preferred): ITIL, CompTIA A+, or other relevant certifications.
• The IT Support Engineer should be adaptable, detail-oriented, and possess a customercentric approach to problem-solving. This role requires staying up to date with industry
trends and technologies to provide effective support in a rapidly evolving IT landscape.
Work Environment
• The position may require working in a laboratory or office environment.
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