Job Description
Essential Duties and Responsibilities:
- Develop and implement strategies for integrating I&OT systems to enhance operational efficiency and security.
- Collaborate with cross-functional stakeholders to design, develop, and maintain I&OT Networks and Cybersecurity needs in GMP and non-GMP areas.
- Drive the development of policies and innovative computerized solutions to achieve results.
- Responsible for all technology-related system integrations across different software platforms and systems such as Asset Management System, Active Monitoring System, Operator Management and Access Control System, Alarm Management System, Disaster Recovery System, Historians.
- Manage yearly budgets.
- Develop and implement strategies to ensure data integrity and compliance across I&OT systems.
- Define and enforce Management of Change process through cross functional collaboration.
- Collaborate with vendors and third-party providers through the entire lifecycle of projects.
- Proficient with 21 CFR part 11.
- Lead, develop, review, and approve detailed specifications, engineering documents, SOPs, test scripts, and engineering standards in compliance with site procedures and industry standards.
- Define processes and tools to improve predictability and reliability of I&OT Systems.
- Educate other I&OT and automation colleagues in the site technologies, I&OT procedures, and industry standards.
- Consistently leading by example, being a role model and change agent for all team members and the corporate technology team.
Minimum Qualifications (Knowledge, Skills, and Abilities)
- Bachelor’s degree in engineering, Information Technology, or related field (Master’s Degree preferred).
- Minimum 12+ years of experience in architecting, planning, implementing, and maintaining IT & OT solutions in a regulated environment.
- Experience with cybersecurity frameworks and standards (e.g., NIST, IEC 62443).
- Demonstrated experience with designing and integrating complex OT systems with IT.
- Demonstrated experience with integrating multiple IT & OT systems to drive operational and security objectives.
- Excellent collaboration, oral, and written communication skills, including the ability to communicate/translate technical concepts in a business framework.
- Ability to build collaborative relationships and productive working partnerships across cross-functional teams.
- Ability to work through and manage ambiguity to drive decisions in complex, fast-paced, and dynamic environment.
- Demonstrated ability to effectively lead and influence leaders and team members to choose new working methods.
- Knowledge of pharmaceutical manufacturing processes, regulatory requirements, data integrity guidelines, and FDA expectations.
Preferred Qualifications:
- Certifications such as IEC62443, GICSP or PMP (Project Management Professional) are advantageous.
- Experience in sterile fill-finish facility manufacturing.
- Experience with regulatory inspections.
- Programming Switches, Firewalls, and custom scripts.
- Experience with Thin Clients, SQL Server design, implementation, and support.
Job Tags
Flexible hours,