IT Expert

**Job Overview**

We are seeking a highly skilled IT Specialist to join our team in the pharmaceutical manufacturing environment. The successful candidate will be responsible for managing all IT operations at the plant, ensuring alignment with corporate IT standards and regulatory requirements.

• The ideal candidate will have a strong understanding of GxP, 21 CFR Part 11, and other applicable regulatory requirements.

• In addition, they will have experience with ITIL processes and system validation life cycle SDLC.

• Strong troubleshooting analytical and communication skills are also essential for this role.

Responsibilities:

• Manage all IT operations at the manufacturing plant, ensuring alignment with corporate IT standards and regulatory requirements.

• Provide GxP-compliant support for manufacturing systems MES, LIMS, SCADA, etc., and ensure proper documentation and validation protocols are followed.

• Act as the primary IT contact for plant and quality assurance teams.

• Support audits and inspections by regulatory bodies FDA, EMA, etc., by providing required documentation and demonstrating compliance.

• Implement and monitor cybersecurity protocols in the plant environment.

• Coordinate the rollout of new IT systems and upgrades while ensuring minimal disruption to manufacturing operations.

Qualifications & Skills:

• Bachelor's degree in computer science or Information Technology.

• 3+ years of IT experience with at least 2 years in a pharmaceutical manufacturing environment.

• Experience with ITIL processes and system validation life cycle SDLC.

• Strong knowledge of GxP, 21 CFR Part 11, and other applicable regulatory requirements.

• Strong troubleshooting analytical and communication skills.