Manager, Automation & MES

Cordenpharma

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