
Plant IT Specialist
1 day ago
Job Title: Plant IT – Pharma
Key Responsibilities:
- Manage all information technology 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.
- Maintain and update IT standard operating procedures in compliance with GxP standards.
- Collaborate with vendors and third-party service providers for support and maintenance of plant systems.
- Train and support end-users on relevant IT systems and best practices.
Qualifications & Skills:
- Bachelor's degree in computer science, Information Technology, or related field.
- 3+ years of IT experience, with at least 2 years in a pharmaceutical manufacturing environment.
- Strong knowledge of GxP, 21 CFR Part 11, and other applicable regulatory requirements.
- Experience supporting or managing systems such as MES, LIMS, SCADA, or ERP in a GMP environment.
- Familiarity with ITIL processes and system validation life cycle (SDLC).
- Strong troubleshooting, analytical, and communication skills.
- Ability to manage projects and coordinate cross-functional teams.
- Experience with audit readiness and participation is a strong advantage.
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