Corden Pharma Colorado logo

Manager, Automation & MES

Corden Pharma Colorado
  • Boulder, CO
    Today

    Job Description

    Job Description

    Job Description

    CordenPharma 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.

     

    Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being.

     

    Our People Vision

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

     

    SUMMARY

    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

    Include the following. Other duties may be assigned.

    • 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

     

    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. 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.

     

    QUALIFICATIONS

    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily while proficiently demonstrating the Core Competencies listed below. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions described. 

     

    The following requirements are representative of the knowledge, skill, and/or ability required for this role. The individual must demonstrate a business working knowledge of the following:

    • 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

     

    EDUCATION and/or EXPERIENCE

    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.

     

    LANGUAGE SKILLS

    Ability to read and understand common information technology technical literature. Ability to effectively communicate verbally and in writing with peers, customers, and management.

     

    MATHEMATICAL SKILLS

    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.

     

    REASONING ABILITY

    Ability to apply problem-solving and best judgement to assigned tasks.

     

    CERTIFICATES, LICENSES, REGISTRATIONS

    None.

     

    PHYSICAL DEMANDS

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

     

    While performing the duties of this job, the employee is frequently required to stand; walk; work with hands; stoop, kneel, crouch, or crawl; and talk or hear. The employee is occasionally required to sit, reach above shoulder height, and climb or balance. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

     

    WORK ENVIRONMENT

    The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

     

    While performing the duties of this job, the employee may be exposed to fumes or airborne particles and low levels of toxic or caustic chemicals. The employee may be exposed to moving mechanical parts, outside weather conditions, and risk of electric shock. The noise level in the work environment is usually moderate.

     

    CORE COMPETENCIES

    These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.

    • 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.)

     

    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. Corden Pharma embraces fair hiring practices.

     

    This post will expire September 04, 2026

    Numbers & Facts

    LocationBoulder, CO
    IndustryBiotechnology/Pharmaceuticals
    Company Size2,500 to 4,999 employees
    Year Founded2006
    Websitehttp://www.cordenpharma.com/

    Benefits

    Paid Sick Days, Parking, Performance Bonus, Prescription Drug Coverage, Professional Development, 401K, Flexible Spending Accounts, Employee Events, Retirement / Pension Plans, Tuition Reimbursement, Work From Home, Life Insurance, Military Leave, On Site Cafeteria

    About Company

    Innovation and Skills that Make a Difference

    Corden Pharma Colorado, one of multiple cGMP Corden Pharma facilities located across Europe and the US, plays an important role in the platform of pharmaceutical research, development and manufacturing facilities of our parent company, Corden Pharma.

    Corden Pharma Colorado's chemists and engineers are widely recognized for their history of innovation, having developed highly efficient manufacturing processes for some of the world's most complex pharmaceutical compounds.

    Corden Pharma Colorado also is a highly accomplished manufacturing facility, with the flexibility to handle sophisticated manufacturing techniques while readily adapting to the ever changing market demand for new products.

    Ultimately, the medicines Corden Pharma Colorado has a hand in producing find their way to patients around the globe, helping them survive and enjoy more comfortable lives. In this way, we are proud to share in the tradition of innovation and skills that have made Corden Pharma one of the most respected CMOs worldwide.

    Skills

    • Accountingunmatched
    • Active Pharmaceutical Ingredient (API)unmatched
    • Administrative Skillsunmatched
    • Algebraunmatched
    • Allen-Bradleyunmatched
    • Analysis Skillsunmatched
    • Application Programming Interface (API)unmatched
    • Asset Managementunmatched
    • Automationunmatched
    • Automation Engineeringunmatched
    • Automation Systemsunmatched
    • Biologyunmatched
    • Biotech and Pharmaceuticalunmatched
    • Budgetingunmatched
    • Business Operationsunmatched
    • Business Processesunmatched
    • Calculusunmatched
    • Capital Expenditure (CAPEX)unmatched
    • Capital Projectunmatched
    • Career Developmentunmatched
    • Cash Flow Projectionunmatched
    • Change Controlunmatched
    • Change Managementunmatched
    • Chemistryunmatched
    • Commissioningunmatched
    • Communication Skillsunmatched
    • Communications Protocolsunmatched
    • Computer Softwareunmatched
    • Computer Systemsunmatched
    • Continuous Improvementunmatched
    • Contract Manufacturingunmatched
    • Control Systemsunmatched
    • Corrective Actionunmatched
    • Cross-Functionalunmatched
    • Current Good Manufacturing Practice (cGMP)unmatched
    • Customer Support/Serviceunmatched
    • DHCP (Dynamic Host Configuration Protocol)unmatched
    • DNS (Domain Name System)unmatched
    • DeltaVunmatched
    • Dental Insuranceunmatched
    • Depth Perceptionunmatched
    • Disciplinary Actionunmatched
    • Distributed Control Systems (DCS)unmatched
    • Documentationunmatched
    • Drug Productsunmatched
    • Electrical Componentsunmatched
    • Electricityunmatched
    • Electronicsunmatched
    • Employee Assistance Planunmatched
    • Environmental Sciencesunmatched
    • FDA (Food and Drug Administration)unmatched
    • Functional Testingunmatched
    • Hospitalunmatched
    • Human Machine Interface (HMI)unmatched
    • ICH Regulationsunmatched
    • Identify Issuesunmatched
    • Information Technology & Information Systemsunmatched
    • Instrumentationunmatched
    • Internal Rate of Return (IRR)unmatched
    • Leadershipunmatched
    • Lean Manufacturingunmatched
    • Lean Six Sigmaunmatched
    • Maintain Complianceunmatched
    • Manufacturing Equipmentunmatched
    • Manufacturing/Industrial Processesunmatched
    • Mathematicsunmatched
    • Medical Equipmentunmatched
    • Medical Productsunmatched
    • Microsoft Active Directoryunmatched
    • Microsoft Officeunmatched
    • Microsoft VBScript (Visual Basic Script) Scripting Languageunmatched
    • Microsoft Windows 7unmatched
    • Microsoft Windows Operating Systemunmatched
    • Microsoft Windows XPunmatched
    • Multiplatform/Cross-Platformunmatched
    • Multitaskingunmatched
    • Network Supportunmatched
    • Oncologyunmatched
    • Operations Managementunmatched
    • People Managementunmatched
    • Performance Metricsunmatched
    • Performance Reviewsunmatched
    • Physical Demandsunmatched
    • Pipingunmatched
    • Presentation/Verbal Skillsunmatched
    • Preventative Maintenanceunmatched
    • Problem Solving Skillsunmatched
    • Procedure Developmentunmatched
    • Process Control Engineeringunmatched
    • Production Scheduleunmatched
    • Programmable Logic Controller (PLC)unmatched
    • Project Executionunmatched
    • Project Lifecycleunmatched
    • Project/Program Managementunmatched
    • Quality Managementunmatched
    • Quality Metricsunmatched
    • Regulationsunmatched
    • Regulatory Complianceunmatched
    • Regulatory Requirementsunmatched
    • Reporting Dashboardsunmatched
    • Return on Investment (ROI)unmatched
    • Riskunmatched
    • Roboticsunmatched
    • SQL (Structured Query Language)unmatched
    • Safety/Work Safetyunmatched
    • Small Moleculesunmatched
    • System Integration (SI)unmatched
    • System Validationunmatched
    • Systems Maintenanceunmatched
    • TCP/IP (Transmission Control Protocol/Internet Protocol)unmatched
    • Technical Leadershipunmatched
    • Technical Operationsunmatched
    • Technical Supportunmatched
    • VMWareunmatched
    • Validation Planunmatched
    • Virtualization Softwareunmatched
    • Writing Skillsunmatched

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