The Senior Manager of Operational Technology plays a critical leadership role in Client's pharmaceutical organization, overseeing the operation and integration of operational technology (OT) systems. The site serves as a new fill-finish facility, dedicated to manufacturing and supplying essential generic sterile injectable medications.
You will play a critical role in ensuring our OT data systems' integrity, security, and reliability and maintaining compliance with regulatory standards. You will collaborate closely with cross-functional teams, including Engineering, Manufacturing, IT, and Quality.
Essential Duties and Responsibilities:
· Operational Technology Management:
- System Architecture: Oversee the design, implementation, and maintenance of OT systems, including process control, automation, and manufacturing execution systems.
- Risk Assessment: Evaluate risks associated with OT systems and develop mitigation strategies. Ensure robust cybersecurity measures to protect critical infrastructure.
- Vendor Management: Collaborate with vendors and third-party providers to ensure seamless integration of OT solutions. Evaluate vendor compliance with data integrity standards.
- Responsible for all technology-related system integrations across different software platforms and systems.
- Maintain infrastructure systems, disaster recovery, and systems/network security with the systems engineering team. Responsible for Disaster Recovery and Business Continuity initiatives.
- Facilitates IT security audits and or investigations.
- Analyzes IT infrastructure and systems performance to assess operating costs, productivity levels, upgrade requirements, and other metrics and needs.
- Ensure operational requirements and coordinate with system requirements for future growth and strategy to align with highly available applications and systems.
- Lead, develop, review, and approve detailed specifications, engineering documents, SOPs, test scripts, and engineering standards in compliance with site procedures and industry standards.
- Consistently leading by example, being a role model and change agent for all team members and the corporate technology team.
- Mentor other IT and automation colleagues in the site technologies, IT procedures, and industry standards.
- Manages the implementation of software solutions across various functional areas.
- Automate the configuration, testing, monitoring, and backup of our process infrastructure.
- Research, test, and deploy software and hardware tools necessary on a project basis.
- Build and maintain tools to improve predictability and reliability of releases and deployments.
· Data Integrity and Compliance:
- Champion Data Integrity: Develop and implement strategies to ensure data integrity across IT and OT systems.
· Data Integrity Controls Implementation:
- Define and enforce robust access controls for data entry, modification, and deletion.
- Implement electronic signatures and audit trails to track changes and ensure accountability.
- Validate data migration processes to prevent data corruption during system upgrades.
- Collaborate with IT and OT teams to establish secure data transfer protocols.
- Conduct risk assessments specific to data integrity and develop mitigation plans.
· Support operational technology and the process control network.
· IT/OT network architecture development.
· HMI/SCADA system development for Rockwell Factory Talk including:
o SCADA graphics and database
o Virtualized server systems.
o 21 CFR Part 11 Compliance.
· Rockwell/Allen Bradley Control Logix programming.
· PLC hardware selection/control panel design.
· Modification and expansion of the above systems in a qualified environment.
· Qualification of automation systems for the pharmaceutical industry.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Minimum Qualifications (Knowledge, Skills, and Abilities)
- Bachelor’s degree Computer Science, Information Technology, or related field (Master’s preferred)
- Minimum 10+ years of experience in architecting, planning, and/or leading teams to implement OT solutions
- Demonstrated experience with minimum 2 years of the following systems: ERP, CRM, MES, PLM, QM, Analytics
- Excellent collaboration, oral, and written communication skills, including the ability to communicate/translate technical concepts in a business framework that non-technical people easily understand.
- Ability to build collaborative relationships and productive working partnerships across cross-functional teams.
- Capable of working independently against deadlines in an ambiguous, fast-paced, dynamic environment.
- Demonstrated ability to effectively lead and influence leaders and team members to choose new working methods.
- Understanding pharmaceutical manufacturing process and regulatory requirements and working knowledge of cGMP practices.
- Ability to work through and manage ambiguity to drive decisions in complex and dynamic situations· Proficiency in using scheduling software and ERP systems.
- Knowledge of CGMP regulations, data integrity guidelines, and FDA expectations.
Preferred Qualifications:
- Certifications such as CISSP (Certified Information Systems Security Professional) or PMP (Project Management Professional) are advantageous.
· Experience in sterile fill-finish facility manufacturing.
· Experience with regulatory inspections.
· Programming Switches, Firewalls, and designing networking architecture is preferred.
· ThinManager/Thin Clients, SQL Server design, implementation, and support.
- Experience with BMS, EMS systems, OPC, ODBC, Data Historians, WIN911, as well as Chillers, Boilers, HVAC and Wastewater systems
