Associate Director Automation (237)

Civica Rx; Petersburg (VA); Sur place; USD 150 000 - 210 000; Plein temps

Résumé du poste

Civica Petersburg seeks an Associate Director of Automation to lead the site automation strategy and governance for clinical and commercial operations. You will oversee design, implementation, and compliant operation of ICS across DCS, SCADA, PLC, and BMS systems in a fast-paced startup environment.

The role requires hands-on technical support, deep knowledge of CSV, and collaboration with IT and Quality to ensure scalable, reliable automation that supports startup and sustained manufacturing

Qualifications

• Bachelor's degree or equivalent technical degree.
• 10+ years of progressive automation or related pharmaceutical industry experience.
• 5+ years of automation execution subject matter expertise.
• Experience developing test plans, user requirements, and system design documents.
• Strong programming and troubleshooting knowledge for Rockwell or Siemens PLCs and HMI platforms.

Responsabilités

• Develop and execute the site automation strategy.
• Lead Automation Engineering support for mission-critical manufacturing systems (data historians, central monitoring, SCADA, PLCs).
• Ensure plant operations support commissioning, validation, safety, compliance, and quality manufacturing.
• Manage automation engineers and partner with IT, Quality, Validation, and other teams to deliver priorities.
• Provide hands-on support for Manufacturing and Operations, including troubleshooting and issue resolution.
• Set priorities for the site systems landscape, validation lifecycle, and standards (S95/S88).
• Build and develop a high-performing team with focus on innovation, quality, and inclusion.
• Maintain inspection and audit readiness, cybersecurity, data integrity, and alarm management.
• Mentor, coach, and evaluate automation engineers.

Connaissances

Leadership

Program management

Team-building

Budgeting

Regulatory compliance

Formation

Bachelor's degree

Outils

Rockwell PLC

Siemens PLC

FTView

GE iFix

Wonderware System Platform

SQL

AVEVA PI

VMware

Description du poste

Job Description

The Associate Director of Automation develops and implements the site automation strategy and leads a site-based team responsible for the design, implementation, and compliant operation of Civica Petersburg's automation and industrial control systems (ICS). This includes systems supporting facility, utility, and manufacturing processes across both clinical and commercial operations, as well as close partnership with the IT/OT team to maintain the process control network. Plant systems include DCS, SCADA, PLC, BMS, EMS, data historians, and analytics solutions. As the functional leader, this role sets direction, makes decisions, balances priorities, represents the Automation Engineering function in cross-functional governance and decision-making, and manages cross-functional projects in a fast-paced startup environment. The incumbent is expected to contribute hands-on technical support as needed, provide expertise in manufacturing and compliance standards (including Computerized Systems Validation - CSV), guide team members, and advise key business leaders on automation strategy. This role is accountable for ensuring reliable, compliant, and scalable automation systems that enable efficient site startup and sustained manufacturing performance.

Essential Duties and Responsibilities

• Develop and execute the site automation strategy.
• Lead Automation Engineering support for mission-critical manufacturing systems, including data historians, central monitoring systems, process automation, building management, SCADA, and PLC systems.
• Ensure plant execution and operations systems support commissioning, validation, safety, compliance, and quality manufacturing across clinical and commercial production.
• Manage automation engineers and represent Automation Engineering while partnering with IT, Quality, Validation, Manufacturing, Engineering, Technical Services, vendors, and other teams to deliver automation priorities.
• Provide strategic direction and hands-on support for Manufacturing and Operations, including troubleshooting and issue resolution for business-critical needs.
• Set priorities for the site systems technology landscape, including new facilities, system changes, validation lifecycle strategy, and S95/S88 standards, libraries, and systems.
• Build and develop a high-performing team while fostering innovation, quality, compliance, accountability, engagement, collaboration, diversity, and inclusion.
• Maintain inspection and audit readiness for automation systems, including cybersecurity requirements, data integrity, and alarm management.
• Mentor, coach, train, and evaluate automation engineers.
• Implement automation policies, procedures, SOP authorship and oversight, and system support aligned with regulations and industry standards.
• Analyze process issues and recommend corrective and preventive actions.
• Support sitewide cybersecurity alignment and direction.
• Lead continuous improvement efforts, promote best practices, and ensure safety is integral to all activities.
• Serve as an automation SME during regulatory inspections, including FDA and DEA inspections.
• Demonstrate strong leadership, communication, team-building, coaching, budgeting, and resource-management skills.

Basic Qualifications and Capabilities

- Bachelor's degree or similar technical degree required.

• 10+ years of progressive automation or related pharmaceutical industry experience.
• 5+ years of automation execution subject matter expertise.
• Experience developing test plans, user requirements, and system design documents.
• Strong programming and troubleshooting knowledge for Rockwell or Siemens PLCs and HMI platforms, including FTView, GE iFix, and/or Wonderware System Platform.
• Strong knowledge of computerized systems, compliance regulations, and standards, including Computerized Systems Validation (CSV).
• Support the full engineering project lifecycle for sterile injectable automation and instrumentation, from design through commissioning, qualification, troubleshooting, and continuous improvement.
• Collaborate across Operations, Quality, Regulatory, Process Development, Supply Chain, and other GMP manufacturing groups to resolve business-critical issues.
• Demonstrated leadership, team-building, communication, coaching, planning, and organizational skills.
• Strong project and time management skills, with the ability to influence in a matrixed environment and balance production and maintenance needs.
• Ability to forecast and manage departmental budgets and cost center resources.
• Knowledge of SQL, AVEVA PI, database, and historian systems.
• Experience with VMware, virtualization, and basic networking.
• Familiarity with automation platforms, PLCs, SCADA, PI Historian, Industrial Ethernet, Profibus, and AS-I networks.
• Experience in a sterile injectable environment.
• Understanding of biotech data integrity principles and FDA guidance.
• Exposure to batch or continuous pharmaceutical/biotech manufacturing.
• Experience with S88, ASTM 2500, CSV, regulatory inspections, and large capital projects.
• Strong teamwork and organizational skills, with experience using continuous improvement and lean tools.

Preferred Qualifications

• Knowledge of SQL, AVEVA PI, database, and historian systems.
• Experience with VMware, virtualization, and basic networking.
• Familiarity with automation platforms, PLCs, SCADA, PI Historian, Industrial Ethernet, Profibus, and AS-I networks.
• Experience in a sterile injectable environment.
• Understanding of biotech data integrity principles and FDA guidance.
• Exposure to batch or continuous pharmaceutical/biotech manufacturing.
• Experience with S88, ASTM 2500, CSV, regulatory inspections, and large capital projects.
• Strong teamwork and organizational skills, with experience using continuous improvement and lean tools.