Job DescriptionJob DescriptionCordenPharma 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 VisionWe strive for excellence. We share our passion. Together, we make a difference in patients' lives.
SUMMARY
The Corden Pharma Automation & Information Technology (IT) Department provides support for IT automated operations used by our multi-site business customers. Repeatable Automation/IT services are designed and built to reduce costs and cycle times, eliminate failures, meet regulatory requirements, and improve customer satisfaction.
As a regulated pharmaceutical manufacturer, Corden Pharma Automation/IT services must align with FDA and EMEA regulatory standards; and be tailored to meet specific internal and/or client contract requirements.
Standard Automation/IT services include, but are not limited to, operations for communications, networks, data centers, enterprise systems and application support, help desk and end user services, application development, end user device management, asset management, patch management, release management, desktop management, and server/storage management.
As such, Corden Pharma Automation/IT Professionals are responsible for the direction, definition, design, development/application, integration, deployment, documentation, and operational consulting support of Corden Pharma Systems software, and equipment used in control systems, manufacturing information systems, lab systems, and business systems.
Serves as the department subject matter expert (SME) and support Corden Pharma’s process control systems. Additionally, this individual will be responsible to lead and execute small automation and control system projects. This role will:
- Perform process automation preventative maintenance tasks
- Identify and implement control system changes which improve the safety and efficiency of Corden Pharma plant operations
- Lead the delivery of process automation training to operations personnel
- Assist our customers with integrated IT/automation services that ensure proprietary and confidential data are protected per mandated regulatory standards and established customer agreements
Projects will include industrial life sciences equipment installations, commissioning, maintenance, plant troubleshooting, and programming.
Primary responsibilities will be to serve as the SME regarding technical issues; attend and participate in customer meetings; support the management of project research and development efforts; and mentor/develop our department technical resources as applicable.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Include the following. Other duties may be assigned.
- Generate detailed requirements for connectivity solution for DeltaV Systems
- Automate sequences of events with DeltaV Batch based on inputs from Process Engineering representatives and documentation
- Perform the detailed design for projects by converting engineering and system design into drawings, control panel designs, and installation details consistent with the specification and functional descriptions
- Interact with MES to automate batch actions via electronic controls and documentation
- Establish test plans to determine compliance with functional and design requirements
- Establish methods and processes to deploy, install, and configure customer specific control and network strategies
- Resolve technical questions and concerns through interaction with customers, vendors and internal personnel
- Train users on the specifics of Corden Pharma Automation/IT Systems
- Maintain daily performance support of Corden Pharma Automation/IT Systems. Maintain computer source images and drivers. Run diagnostic programs to resolve problems
- Resolve technical problems with Corden Pharma Automation Local Area Networks (LAN) and other process control infrastructures/systems
- Lead the implementation of changes to the Process Control System and process control applications, ensuring compliance of the Process Automation Change Control System
- Provide system maintenance and troubleshooting, including preventative maintenance tasks. Responsible for supporting plant coverage to ensure process control systems operate essentially with no downtime
- Lead the validation of new control applications and maintenance of process controls systems in a validated state
- Identifies process control system improvements to improve system performance while adhering to established standards
- Supports the review of user requirements while leading the development of automation plans for small projects. Assists management where applicable in the development of automation plans for larger projects
LEADERSHIP & BUDGET RESPONSIBILITIES
While this role has no direct supervisory responsibilities, the individual will be considered a critical SME for the department and lead by example.
Role expectations include demonstrating a positive attitude that supports a positive, healthy, and flexible work environment, and provides peer mentorship for department staff.
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.
The following requirements are representative of the knowledge, skill, and/or ability required for this role. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The individual must demonstrate a business working knowledge of the following:
- PLC programming (i.e., Allen Bradley)
- HMI development and programming
- Automation communication protocols and radio communications
- Automated valve sizing and management
- Ability to interpret electrical and process instrumentation drawings (P&IDs)
- Understanding of Modbus protocol
EDUCATION and/or EXPERIENCE
Bachelor’s Degree in Electrical Engineering, Chemical Engineering, or related STEM Major; and demonstrate 5 years’ experience in a manufacturing automation environment, or equivalent combination of education and previous work experience. Distributed control system training and programming experience is desired for this position.
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 add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, percent, and to draw and interpret bar graphs.
REASONING ABILITY
Ability to apply problem-solving and best judgement to assigned tasks.
CERTIFICATES, LICENSES, REGISTRATIONS
IPSE certification for GAMP and/or Data Integrity .
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, 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.
- Knowledge and ability applying scientific problem-solving methods, as demonstrated with schoolwork performance and work experience
- Proficiency with the Microsoft Office Suite, Visual Basic, SQL scripting
- Strong knowledge of computer systems (software and hardware)
- Basic Active Directory administration experience
- Familiarity with virtualization software, i.e., VMWare
- Server/desktop/laptop image development and management
- Knowledge and experience with Windows XP/Windows 7/Windows 10
- Networked client-server environment experience (e.g., TCP/IP, DNS, DHCP, etc.)
- Analytical and troubleshooting skills including strong math, reading, and comprehension abilities
- Demonstrated mechanical aptitude and base knowledge of chemistry, chemical processing theories, application, equipment, and plant operations
- Demonstrated experience as a system/application subject matter expert (SME) for at least one critical automation system
- Ability to handle multiple tasks simultaneously while being flexible to changing work schedules
- Excellent customer service and verbal/written communication skills
- Lead by example as a team player who can multi-task
- Demonstrate project management skills
- Willingness to learn and help others learn new technologies
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 , , , , sex, origin, disability status, genetics, protected veteran status, , gender or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices.
This post will expire December 31, 2025