Senior IT Professional
2 days ago
Job Title: Plant IT – Pharma
Key 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.
- Manage local infrastructure (servers, networks, desktops, printers) and coordinate with central IT teams for enterprise-level support.
- 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 SOPs 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.
- 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.
The ideal candidate will have a strong background in IT and pharmaceutical manufacturing, with experience in managing systems compliant with GxP regulations. They will be responsible for managing IT operations at the manufacturing plant, providing support for manufacturing systems, and collaborating with vendors and third-party service providers. The candidate should have strong knowledge of GxP, 21 CFR Part 11, and other applicable regulatory requirements, as well as experience with ITIL processes and system validation life cycle (SDLC).
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