Job Description
The IT Application Support Engineer plays a pivotal role in ensuring the optimal performance and availability of pharmaceutical applications.
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 in-person.
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, including 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:
o Prepare for and participate in regulatory inspections and audits.
o 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.
* Work Environment:
o The position may require working in a laboratory or office environment.
o On-call support as well weekend support may be required to address critical issues outside of regular business hours.