Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. "Race to the bottom" pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.
Who suffers most? Patients.
Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.
Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients."
Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.
More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.
Long- and short-acting insulins will be produced and available in both vials and pre-filled pens - at no more than $30 per vial and no more than $55 for a pack of five pens.
Learn more about Civica's plans and progress at www.civicarx.org
Job Description:
The Senior Manager of Operational Technology plays a critical leadership role in Civica's pharmaceutical organization, overseeing the operation and integration of operational technology (OT) systems at the Petersburg site. The Petersburg site serves as Civica's 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:
SCADA graphics and database
Virtualized server systems.
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
