
Pharma Manufacturing Technology Lead
2 days ago
Job Summary:
We are seeking an experienced IT professional to oversee all IT operations at our manufacturing plant. The ideal candidate will have strong knowledge of regulatory requirements, GxP, and 21 CFR Part 11.
Key Responsibilities:
Manage IT Operations: Ensure alignment with corporate IT standards and regulatory requirements.
GxP-Compliant Support: Provide support for manufacturing systems (MES, LIMS, SCADA, etc.) and ensure proper documentation and validation protocols are followed.
Primary IT Contact: Act as the primary IT contact for plant and quality assurance teams.
Support Audits and Inspections: Provide required documentation and demonstrate compliance during audits and inspections by regulatory bodies.
Local Infrastructure Management: Manage local infrastructure (servers, networks, desktops, printers) and coordinate with central IT teams for enterprise-level support.
Cybersecurity Protocols: Implement and monitor cybersecurity protocols in the plant environment.
IT System Rollout and Upgrades: Coordinate the rollout of new IT systems and upgrades while ensuring minimal disruption to manufacturing operations.
IT SOP Maintenance: Maintain and update IT SOPs in compliance with GxP standards.
Vendor Collaboration: Collaborate with vendors and third-party service providers for support and maintenance of plant systems.
End-User Training: 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.
IT Experience: 3+ years of IT experience, with at least 2 years in a pharmaceutical manufacturing environment.
Regulatory Knowledge: Strong knowledge of GxP, 21 CFR Part 11, and other applicable regulatory requirements.
System Support Experience: Experience supporting or managing systems such as MES, LIMS, SCADA, or ERP in a GMP environment.
ITIL Processes: Familiarity with ITIL processes and system validation life cycle (SDLC).
Problem-Solving Skills: Strong troubleshooting, analytical, and communication skills.
Project Management: Ability to manage projects and coordinate cross-functional teams.
Audit Readiness: Experience with audit readiness and participation is a strong advantage.
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