Objectives:

The Manager/Senior Manager –Automation and Information Technology (AIT) will oversee the development, implementation, and maintenance of Hilleman Laboratories automation infrastructure and information technology and systems. This role will ensure that the organization's automation and IT solutions align with regulatory requirements, support CMC development operations, GMP manufacturing processes, and enhance operational efficiency. The ideal candidate will support cross-functional teams, manage AIT projects, and maintain the integrity and security of information system and automation infrastructures to support Hilleman laboratories Mission for Impact.

Key Responsibilities:

Strategic Leadership:

• Develop and execute the information technology system and services and automation strategy to support CMC laboratory and GMP-compliant manufacturing operations.
• Align IT and automation infrastructure with corporate objectives, regulatory guidelines, policies in line with local and international regulations and industry best practices.
• Act as a subject matter expert (SME) for GMP-compliant IT driven systems, services and automation processes.

System and Infrastructure Management:

• Oversee the design, implementation, and maintenance of GMP-critical IT systems and automation platforms in partnership with outsourced vendors.
• Ensure systems meet GMP regulatory body requirements for data integrity, security, and validation.
• Lead the Troubleshoot of IT solutions and automation related issues in GMP operations
• Manage system lifecycle activities, including upgrades, validation, decommissioning, and migration.
• Establish robust backup, disaster recovery, and cybersecurity measures for Hilleman Laboratory organization systems inclusive of development and testing.
• First point of contact as Subject Matter Expert (SME) for assigned Automation Systems related subjects in the supported business function
• Design and Generate GMP documentation such as Standard Operating Procedures.
• Configuration and programming experience, CMs, EMs, Unit Classes, Recipes, Controllers and Graphics.
• Ensure a seamless data flow through all integration points with hierarchies of system connectivity within all computerized systems.
• Function as a system admin for the automation tasks related to manufacturing activities not limited to user manager, Backup Recovery, Time Sync, Audit Trail.

Compliance and Quality Assurance:

• Ensure systems and processes comply with 21 CFR Part 11, Annex 11, and other applicable regulations.
• Collaborate with Quality Assurance (QA) teams to maintain compliance with GMP requirements.
• Prepare and represent site during audits and inspections related to IT and automation systems.

Project and Team Management:

• Plan, execute, and oversee projects for new system implementations and upgrades.
• Manage budgets, resources, and timelines for IT and automation projects.
• Lead and mentor the IT and automation professional, fostering a culture of compliance and innovation.

Collaboration and Stakeholder Engagement:

• Work closely with manufacturing, quality, and supply chain teams to understand operational needs.
• Partner with external vendors, contractors, and service providers to deliver business driven and GMP-compliant solutions and services.
• Support the Business Continuity Plan for the site
• Serve as the primary point of contact for regulatory bodies and auditors regarding IT and automation systems.

Qualifications:

Education and Experience:

• Bachelor’s degree in computer science, Information Technology, Engineering, or a related field (Master’s preferred).
• Minimum of 6 years of experience in IT, automation, or related fields, with at least 5 years in a GMP-regulated environment.
• Proven experience managing teams and complex projects in manufacturing or pharmaceutical settings.

Technical Skills:

• In-depth knowledge of GMP regulations, including 21 CFR Part 11 and Annex 11.
• Strong understanding of IT infrastructure, automation systems (e.g., SCADA, PLC, MES), and data integrity.
• Proficiency in computer system validation, including IQ, OQ, and PQ protocols.
• Familiarity with ERP systems, LIMS, and other enterprise-level manufacturing applications.

Soft Skills:

• Excellent leadership, communication, and interpersonal skills.
• Strong problem-solving and decision-making abilities.
• Ability to work collaboratively across departments and manage stakeholder expectations.

Additional Requirements:

• Availability for on-call support in critical situations.
• Participate in the design and validation (IQ, OQ, PQ) of all relevant Automation systems (BMS, EMS, Historian, DCS, MES, LIMS, and Process equipment etc)