ITOT Engineer

Job Description Summary

Location:

Carlsbad
Internal job title: ITOT Engineer

The ITOT Engineer will be responsible for maintaining, troubleshooting, and supporting ITOT systems to ensure smooth and reliable operation of a 24/7 manufacturing facility. This role supports the installation, commissioning, and ongoing optimization of ITOT systems and equipment, ensuring compliance with safety, regulatory, and quality standards, and provides technical support to minimize downtime and maintain continuous production. The role also contributes to digital transformation efforts within manufacturing operations, supporting initiatives such as AI, process automation, and robotics, and supports CAPEX projects to commission new production lines.

• ITOT Systems Support: Support, troubleshoot, and enhance ITOT systems including PLCs, HMIs, EMS, BMS, and PC-based control applications to maintain reliability of manufacturing and facility operations. Manage user access, account administration, and periodic reviews.
• IT/OT Infrastructure Support: Assist with maintaining IT/OT infrastructure (servers, virtual machines, network devices, application hosting, backup and disaster recovery), coordinating with IT teams on cybersecurity and system integrity.
• CSV
  
  Activities:
  
  Support Computer System Validation (CSV) activities, including generation and execution of Installation Qualification (IQ) and Operational Qualification (OQ) protocols, to ensure ITOT systems meet regulatory and operational requirements.
• Compliance & Quality Documentation: Support authoring and review of GMP documentation including deviations, change controls, CAPAs, validation protocols, and risk assessments, in alignment with 21 CFR Part 11 and GxP requirements. Participate in audits and inspections by regulatory authorities and internal quality organizations.
• Investigation & Continuous Improvement: Support technical investigations into system failures and deviations, assist with root cause analysis, and contribute to initiatives that improve system performance and efficiency.
• Project Support: Support ITOT and digital transformation projects from concept through commissioning, including FAT/SAT activities, ensuring alignment with GMP, safety, and engineering standards.
• Digital Transformation: Support digital transformation initiatives within manufacturing operations, including driving AI initiatives, process automation, and robotics projects, in collaboration with cross-functional teams.
• CAPEX & New Line Commissioning: Support CAPEX projects to install, qualify, and commission new production lines, coordinating ITOT scope with engineering, project management, and vendor teams.
• Essential On-Call Coverage: Provide on-call support on a rotation basis to support the 24/7 manufacturing facility, promptly addressing ITOT system issues to minimize downtime and maintain continuous production.

• Education:
  
  Bachelor's degree in Engineering, Automation Engineering, Electrical Engineering, Computer Engineering, Computer Science, or a related technical discipline.
• Experience:
  
  2-3 years of hands-on experience with manufacturing control systems such as PLC or DCS, with familiarity setting up IT infrastructure to support OT technologies such as PLCs, DCS, MES, and PI Historians.
• Industry Knowledge: 2-3 years of experience in the pharmaceutical or biotechnology industry with a solid understanding of Good Manufacturing Practices (GMP) and regulatory compliance.
• Proficiency with PLCs (e.g., Allen-Bradley, Siemens) or Distributed Control Systems (DCS), and familiarity with Manufacturing Execution Systems (MES).
• Working knowledge of EMS/BMS platforms and industrial networking.
• Understanding of GMP/GxP regulations, 21 CFR Part 11, and CSV/CSA methodologies, including IQ/OQ protocol generation and execution.
• Familiarity with Change Control, CAPA processes, and root cause analysis.
• Effective communication skills with ability to coordinate across multidisciplinary teams and vendors. Fluency in English.

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