Job Summary:
We are seeking a dynamic and detail-oriented IT Manager with a background in Good Manufacturing Practices (GMP), Computer System Validation (CSV), and ideally chemistry to join our team. The ideal candidate will have a minimum of two years of IT experience and a solid understanding of laboratory environments and regulatory requirements. As an IT Manager, you will oversee IT infrastructure, manage laboratory IT systems, ensure regulatory compliance, and collaborate closely with cross-functional teams to support digitalization efforts within the lab.
Key Responsibilities:
1. IT Infrastructure and System Management:

• Manage, maintain, and optimize IT infrastructure, including servers, networks, software, and laboratory equipment integration.
• Lead the installation, configuration, and troubleshooting of laboratory information management systems (LIMS), chromatography data systems (CDS), and other scientific applications.
• Oversee and manage secure data storage, access controls, and backup/recovery processes.

2. Compliance and Validation (CSV):

• Develop and maintain IT systems in compliance with regulatory guidelines, particularly GMP and Computer System Validation (CSV) standards.
• Author, review, and approve IT-related validation documents, such as IQ, OQ, and PQ protocols, risk assessments, and change control records.
• Ensure adherence to FDA 21 CFR Part 11, Annex 11, and other relevant regulatory frameworks.

3. Collaboration and Stakeholder Engagement:

• Work closely with Quality Assurance (QA), Laboratory Management, and external vendors to implement compliant, efficient IT solutions.
• Act as a key contact for cross-departmental IT support, identifying opportunities for automation and optimization of lab workflows.
• Provide user training and support for lab software systems, ensuring smooth onboarding and usage by chemists and scientists.

4. Security and Risk Management:

• Implement and monitor cybersecurity measures to protect sensitive laboratory and client data.
• Conduct periodic IT audits and vulnerability assessments to ensure the integrity and security of laboratory systems.

5. Project Management:

• Lead and manage IT-related projects, including system upgrades, new software implementation, and cloud migration.
• Develop and monitor timelines, budgets, and key deliverables for IT initiatives aligned with business objectives.

Required Qualifications:

• Bachelor’s degree in Chemistry, Information Technology, Computer Science, or related field (Master’s degree preferred).
• Minimum 2 years of IT experience in a GMP-regulated environment, ideally within a contract laboratory, pharmaceutical, or biotechnology industry.
• Strong knowledge of Computer System Validation (CSV) processes, including experience authoring validation protocols (IQ, OQ, PQ).
• Familiarity with LIMS, CDS, and other lab-based software systems.
• Understanding of regulatory requirements, such as FDA 21 CFR Part 11, Annex 11, and data integrity principles (ALCOA+).
• Solid problem-solving and troubleshooting skills for IT-related issues in laboratory settings.
• Proficiency in IT project management and change control processes.
• Strong interpersonal and communication skills, with the ability to explain technical information to non-technical audiences.

Preferred Skills:

• Experience with chemistry workflows and laboratory instrumentation (e.g., GC/LC-MS, FTIR, UV-Vis spectroscopy).
• Familiarity with cloud-based solutions for lab data management and virtualization tools.