Manager, Automation & MES

Corden Pharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical and biotech companies manufacture medicines with the ultimate goal of improving people’s lives.

We strive for excellence. We share our passion. Together, we make a difference in patients' lives.

The Manager of Automation & MES (OT) leads Engineers, Technical Specialists, SMEs, and contractors responsible for OT controls of manufacturing equipment, support equipment, integration of systems, and site-wide continuous improvement initiatives. This role includes the conceptualization, design, implementation, and documentation of OT projects and lifecycle management in compliance with regulatory requirements. The Manager represents the department during regulatory meetings and audits and oversees hiring, training, career development, performance appraisals, and team motivation.

• Develop and execute a plant-wide OT strategy and roadmap aligned with long-term business objectives and operational excellence targets
• Evaluate, select, and deploy advanced automation technologies (robotics, MES, Delta
  
  V, PAT, historian solutions, reporting, etc.) to improve efficiency, quality, safety, and agility
• Drive adoption of new and existing systems through effective communication, training, and stakeholder engagement
• Manage multi-year expense budgets, timelines, and a cross-functional team of engineers, program managers, and solution architects
• Assist Technical Operations management in CAPEX planning to deploy OT solutions site-wide within capital projects
• Define KPIs, dashboards, and governance frameworks to track program impact
• Collaborate with site leadership and department staff to achieve project goals
• Oversee and support user training for Corden Pharma OT Systems
• Ensure daily performance support for Corden Pharma Automation Systems including preventative maintenance and technical support/troubleshooting to minimize impact to production schedules
• Manage technical problem resolution for Corden Pharma OT networks and other process control infrastructures
• Manage validation of new OT applications, including computer system validation (CSV), and maintain systems in a validated state
• Coordinate and execute continuous improvement projects to implement new equipment, technologies, processes, or materials
• Manage employees and contractors, coordinate with vendors for project execution
• Review and draft equipment drawings, electrical diagrams, system manuals, engineering protocols, and quality system documentation
• Ensure all automation systems comply with regulatory requirements (FDA, cGMP, etc.)
• As a system subject matter expert (SME), be accountable and responsible to provide the necessary support during internal and external regulatory and client audits
• Maintain documentation including functional specification, validation protocols, and change controls
• Provide expertise and improvements to address nonconformance, implement corrective & preventative actions, and execute Commissioning & Qualification activities

Provides direct leadership to department employees and works with other site leaders to manage all assets in an efficient and compliant manner. Conducts all managerial responsibilities in accordance with the organization's policies, regulatory compliance, and applicable laws. Supervisory responsibilities include daily leadership of team, training, and development; interviewing and hiring; managing time and attendance records; performance appraisals; rewarding and disciplining employees;

and resolving daily problems and conflicts.

Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.

Corden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. In following Current Good Manufacturing Practices (cGMP), Corden Pharma Colorado manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable. This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or efficacy.

CPC’s Quality Management System, which incorporates cGMP, is designed to deliver this quality objective. Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company. cGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards. Adherence to clearly defined…