|Date Posted||May 12, 2021|
|Address||726 Heartland Trail, Suite 100|
Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here
Computer System Engineer
The Computer System Engineer will be responsible for supporting the development and maintenance of existing and new automated systems used in the production and laboratory settings. These systems are utilized for controlling, monitoring, operator interfacing, and providing historical and reporting information. This position will work with end users to provide data reporting using Dream Reports or similar. This position participates in the completion of milestones associated with specific projects and supports ongoing validation efforts and quality systems responsibilities in support of the manufacture, testing, and release of formulated drug substance. This role leads the development of concepts and techniques specific to validation and risk management and completes tasks in a creative and effective way. The Computer System Engineer serves as the system engineer and maintenance person for GxP computer-based systems.
This is a permanent, full time position. It is a salaried role. This position is a first shift Monday-Friday 8a-5p role.
Our new, state of the art Madison, WI facility, with expanded mammalian cell line engineering and biomanufacturing capabilities utilizing single-use systems, offers increased flexibility and manufacturing scale to support our customers’ growth. We offer a broad range of integrated formulation and analytical services to solve your most difficult development challenges in Biologics.
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
- Network configuration and management of production process systems under site Operational Technology (separated from corporate IT network).
- Experience with Active Directory and integration to site systems.
- Monitors, maintains and repairs existing production and laboratory control and monitoring systems (PLC, software, etc.).
- SQL, Historian or similar database experience. Configuration, Design, Queries, and logistical extraction for reporting
- Act as Subject Matter Expert (SME) and technical expert to support Computer System Validation (CSV) programs for the validation of new and existing production and laboratory computer systems, including major capital projects and computer systems.
- Reviews and approves change controls to computerized production and laboratory systems through the change control program to assess impact on validated systems.
- Assists in responding to customer / regulatory audit observations and corrective actions as it pertains to computer system validation.
- Bachelor's Degree in technical discipline (e.g. biotechnology, computer science, engineering, information technology) or related field with minimum of 5 years’ related experience.
- Experience with computerized systems including: Dream Report, TrackWise, WonderWare, DeltaV, Allen Bradley, Historian, Unicorn, or similar laboratory / production systems is required.
- Proven understand of ladder logic-based controllers, operator interface systems, historical data collection and reporting software.
- Operational Technologies network experience
- Experience operating with in a PI cloud integrated data repository is a plus.
- Thorough knowledge of cGMP regulations related to CSV including CFR 21 Part 11, EU GMP Annex 11 and GAMP standards (recommended).
- Six Sigma / Lean Manufacturing / Professional Project Management skills a plus