Job Description

The IT/OT Engineer, 2nd Shift, is responsible for providing technical support and assistance to users in Manufacturing, Engineering and QC functions. This role involves working with multi-functional teams to support various GXP systems and resolve user issues. Additionally, they assist in the execution of projects that support department goals.

The Essential Duties and Responsibilities include , but are not limited to, the following:

• Provide support for laboratory, manufacturing, and business systems.
• Perform user access review and account management activities.
• Assist with the installation, configuration, testing, maintenance, and technical training of IT systems.
• Monitor, resolve, and document user-reported issues and computer system risks, taking corrective and preventative actions or escalating as necessary.
• Track reported issues and other actions in a ticketing system.
• Support periodic reviews of GXP systems.
• Check the success or failure of disaster recovery solutions; backup and restore. Escalate to the necessary resources.
• Support domain control and Active Directory for Process Control Network and Laboratory (e.g., Password reset, Unlock User account).
• Participate in project-based work as assigned.
• Communicate with users on incident progress, changes, and outages.

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Bachelor’s degree with 6+ years of experience in computerized system or automation roles in the pharmaceutical or biotechnology industry.
• Understanding systems and applications in laboratories, quality, ERP, business, printing, and network monitoring.
• A familiarity with lab instruments, their functions, and their requirements.
• High level of analytical, problem-solving, and decision-making skills.
• Interpersonal skills, including telephone & email communication, active listening and customer-care
• Ability to diagnose and resolve technical issues.
• Ability to work independently, multi-task, and adapt to changes quickly in a fast-paced environment.
• Understanding of support tools, techniques, and how technology is used to provide IT services
• Knowledge of Data Integrity and how it applies to the Pharmaceutical Industry.

Preferred Qualifications

• Familiarity with Operational Technology components including networks, historians, and switches.
• Familiarity with 21 CFR Part 11 and GAMP 5.
• Working knowledge of quality systems.
• Experience in the administrative features of Microsoft’s enterprise systems, including M365, Entra, and SharePoint.

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