Associate Director, Small Molecule Plant IT Systems

IT Infrastructure and Support:

• Oversee the construction, validation, and support of IT systems specific to Small Molecule Plant operations.
• Supervise the design, construction, validation, and integrity of IT infrastructure including LAN, networking equipment, and servers.
• Install, validate, and maintain IT devices and equipment in QC lab and manufacturing plant environments.

Project Management and Collaboration:

• Work independently to provide technical direction and manage projects with minimal supervision.
• Act as the primary IT interface to identify and prioritize new site development requests.
• Work collaboratively with manufacturing and quality teams to ensure the new plant operates reliably and efficiently in a 24/7 commercial manufacturing environment.

Compliance and Security:

• Partner with project teams and Global IT counterparts to establish a GxP-compliant environment.
• Collaborate with Engineering and QA teams to assess and enhance system data integrity, security, and system integration.
• Ensure adherence to corporate IT strategies and standards, recommending changes when necessary.
• Configure system backups and recovery protocols.

Technology Advancement:

• Play a key role in delivering technology services that enhance business processes.
• Implement the IT vision and advance the company’s systems, processes, and infrastructure.
• Introduce new technologies in a dynamic environment, supporting future growth.

• Extensive knowledge of complex, GxP manufacturing facilities and strong understanding of Good Manufacturing Practice (GMP) and GAMP 5.
• Experienced in authoring and approving validation documents.
• Familiarity with systems such as MES, E-Logbooks, DCS, SCADA, BMS, EMS, and asset management.
• Understanding of networks, firewalls, and data centers, with experience in virtualized environments and distributed infrastructures.
• Experience with Industry 4.0 technologies and proficient understanding of ISA 95 standards.

Technical Skills:

• Knowledge of Allen Bradley and Siemens PLCs, as well as Aveva PI historian.
• Understanding of equipment used in weighing and dispensing, granulation, tableting, and coating processes.

Soft Skills:

• Strong communication and executive presentation abilities.
• Excellent interpersonal skills for effective teamwork.
• Diplomacy and capability to rationalize multiple points of view., * Bachelor’s degree in information technology, Computer Science, engineering or related field
• 8+ years in IT management or leadership roles, with a preference for experience in pharmaceutical manufacturing, particularly in mid-size plants.

Other Experience:

• Project Management, Budget Control, Lean Six Sigma, Greenbelt training and experience, * Proficiency with Windows Server AD, AWS, Network Infrastructure MS-SQL, Smartsheet, Veeva