
IT Specialist for Pharmaceutical Manufacturing
2 days ago
Job Overview:
We are seeking a highly skilled IT Specialist to join our team in a pharmaceutical manufacturing environment. As an IT Specialist, you will be responsible for managing all IT operations at the manufacturing plant, ensuring alignment with corporate IT standards and regulatory requirements.
Key Responsibilities:
- Manage all IT operations at the manufacturing plant, including network infrastructure, system maintenance, and software updates.
- Provide GxP-compliant support for manufacturing systems (MES, LIMS, SCADA) 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) 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 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.
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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