Job Description
Description WHAT FLEXWARE DOES Flexware Innovation is a leading technology integrator that helps forward thinkers in manufacturing and related industries build comprehensive and long-lasting solutions with ease.
Founded in 1996 and based in Indiana, our teams of talented engineers leverage technology to solve real business problems with teams of engineers focused on industrial controls, manufacturing systems integration, software development, business intelligence, and Internet of Things (IoT) devices. Our passion is helping our customers build solutions that stand the test of time by creating solid architecture and helping customers avoid costly design mistakes.
But we're not just invested in technology - we're also invested in people. Our internal promise to our Flexdogs is to have a positive and lasting impact on our families by providing a healthy and engaging work environment. Our environment is fun, family-friendly, energetic, and was nominated for TechPoint's Mira Award for "Company Culture of the Year" in 2017, four Powderkeg awards in 2019, and 5 Powderkeg awards in 2022.
WHAT YOU WILL DO Flexware's Automation Team does a variety of projects for manufacturing clients. Our expertise spans many industries including Pharmaceutical, Life Sciences, Food and Beverage, Discrete, Steel, Municipalities, and several others. As an Automation Engineer, you will assist clients in a variety of projects and work with many different technical tools. We are looking for future Flexdogs that want to serve our customers and enjoy solving technical challenges that will improve our clients manufacturing processes.
As a Systems Integrator, we are always looking for talented engineers that can assist our clients, so if you are interested in working with SOME or ALL of the following control layer systems, please apply!
- Review and approve Kneat documents including: DeltaV software FATs, SATs, Automation Commissioning Test
- Assist in resolving protocol execution issues using critical analysis and develop sound, reasonable solutions
- Assist with the development of system requirements and specifications to ensure requirements are testable and
meet 21 CFR Part 11 - Support generation of Kneat documents
- Review and approve Automation documentation including risk and impact assessments, computer systems
validation plans, user requirements specifications, functional requirement specifications, traceability matrices,
release reports, and all documents and deliverables within the scope of the Automation Master Validation Plan as
needed. - Ensure that the Computer System Validation on the project is conducted in a consistently high standard, within
budget, and that objectives are met on time suiting the company's vision and objectives - Coordinate with various project workstreams including Automation, Automation System vendor(s), CSV, CQV,
Utilities, Process Engineering, and others as needed. - Calibrate, troubleshoot, test, repair, and improve sensing, measurements, and actuation devices
- Attend regularly scheduled project status meetings as needed.
- Perform other duties or work with other technologies as necessary
- Complete Safety, Project Procedure, and Project Instruction training as required
These are just some of the things you may be involved in on a daily basis, but we are looking for individuals that embody our 4 Core Values and are willing to step in where necessary and help our clients be successful. We are looking for individuals that are not afraid to get their hands dirty and be of service to others.
**Please note that we are not interviewing candidates that require sponsorship now or in the future** WHAT YOU MIGHT HAVE DONE BEFORE Flexdogs are a rare breed of engineers. They come from varied backgrounds but typically have some of the following traits
- Received a technical Bachelor's degree such as computer technology, computer systems technology, information systems, or similar technical degree.
- 5+ years' direct Computer System Validation experience in a cGMP pharmaceutical facility working with FDA
regulations - 3+ years' direct Computer System Validation experience working with Emerson DeltaV DCS
- Knowledge of Automation Control Systems, Manufacturing & IT Systems, and methodologies including ASTM2500,
GAMP5, Data Integrity, and application of 21 CFR Part 11/Annex11 - Excellent organizational, oral, and written communication skills and fluency in English with the ability to effectively
communicate within cross-functional teams and to management - Working knowledge of Kneat validation software is required
- Ability to manage commitments while displaying an eagerness to learn and continuously improve
- Knowledge with Drug Substance Manufacturing (DSM) would be beneficial
- MasterControl, ComplianceWire, TrackWise, and Veeva experience is a plus
If you're interested in becoming a Flexdog, we're excited to start a conversation with you! Please reach out to our recruiting team at [email protected] Your inquiry and conversation will be treated with confidentiality, and we will not share your information with others. Flexware Innovation
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