Manager, Automation & MES

About the role

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.

Essential Duties And Responsibilities

• 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, DeltaV, 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
• Oversee and support user training for Corden Pharma OT Systems
• 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

Leadership & Budget Responsibilities

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.

Safety & Environmental Responsibilities

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.

Quality Responsibilities

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.

Qualifications

• B.S. or M.S. in Engineering Field or equivalent OT experience in Pharmaceutical, Chemical, or Medical Device industries
• Eight years of experience in process automation and control systems within regulated pharmaceutical or life sciences environments

Reasoning Abilities

• Proven leadership skills with the ability to influence and drive significant change
• Proven ability in applying scientific problem-solving methods
• Experience managing culture change and deployment of Enterprise transforming solutions
• Proficiency with the Microsoft Office Suite, Visual Basic, and SQL scripting
• Strong knowledge of computer systems (software and hardware)
• Basic Active Directory administration experience
• Familiarity with virtualization software, i.e., VMWare
• Knowledge and experience with Windows XP/Windows 7/Windows 10/Windows 11
• Networked client-server environment experience (e.g., TCP/IP, DNS, DHCP, etc.)
• Strong analytical and troubleshooting skills, including strong math, reading, and comprehension abilities
• Demonstrated mechanical aptitude, base knowledge of chemistry, chemical processing theories, application, equipment, and plant operations
• Demonstrated experience as a system/application subject matter expert (SME) for multiple critical OT systems
• Excellent customer service and verbal/written communication skills
• Proven success implementing advanced OT applications in regulated or high-complexity environments (life sciences, electronics, automotive, etc.)

Salary

Actual pay will be based on your skills and experience.

Benefits

• 401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
• Accident Plan
• Critical Illness Insurance
• Dental Insurance
• Disability Insurance
• Employee Assistance Program
• Flexible Spending Account
• Health Insurance PPO/HSA
• Hospital Indemnity Plan
• ID Theft Protection
• Life Insurance
• Paid Parental Leave
• Tuition Reimbursement
• Wellness Program
• Vacation – Three Weeks 1st Year
• Vision Insurance

Equal Opportunity Employer

Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.