Manager, Automation & MES

Corden Pharma Colorado

67d•Onsite

About The Position

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.

Requirements

DCS, PLC deployment (i.e., DeltaV, Allen Bradley, and Siemens)
HMI development and programming
MES deployment, integration and implementation
Common OT communication protocols
Ability to interpret electrical and piping & instrumentation diagrams (P&IDs)
Strong working knowledge of electrical and controls principles, methods and standards
CAPEX scope, schedule, and budget business processes
Management and collaboration with Contract resources
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.
Ability to read and understand common information technology technical literature.
Ability to effectively communicate verbally and in writing with peers, customers, and management.
Ability to comprehend and apply principles of advanced calculus, modern algebra, and advanced statistical theory.
Ability to understand basic accounting and financial principles (ROI & IRR analysis, cashflow, committed vs. actual costs, etc.) as they apply to Automation Engineering.
Ability to apply problem-solving and best judgement to assigned tasks.
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
Ability to handle multiple tasks simultaneously while being flexible to changing work schedules
Excellent customer service and verbal/written communication skills
Demonstrated project management skills
Willingness to learn and help others learn new technologies
Routinely demonstrates a proactive approach to problem identification and resolution
Has a consistent record of contributing innovative and practical solutions to technical problems; develops or directs the development of solutions to complex technical problems where little or no precedence exists
Experience validating manufacturing processes and applying risk-based approaches to validation
Familiarity with lean manufacturing, Six Sigma, and continuous improvement methodologies
Proven success implementing advanced OT applications in regulated or high-complexity environments (life sciences, electronics, automotive, etc.)

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
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 procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado.

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