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 peoples 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 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 Pharmas 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. CPCs 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 language
EDUCATION and/or EXPERIENCE
Bachelors 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.
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 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 preferred.
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 th