Responsibilities :
Update or create, application / software / IT use case documents and requirement specifications.
Define technical project scope and objectives.
Application / software / IT functional specification documents.
Commissioning documents (i.e. unit tests, software verification tests).
Independently provide for the delivery of manufacturing modules for an ERP system by : o Configuration of parameters, forms, and workflows in the software to define application behavior.
Lead application demonstrations and work with end-users to insure user requirements are met.
Execute commissioning; support validation team's installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities.
Function as an application level system administrator.
Collaborate to produce Standard Operating Procedures (SOPs) and training materials; conduct training for SOPs.
Develop reporting tools to support quality assessment.
Practice and stay current with ISPE GAMP best practices, FDA GxP regulations, and applicable ISO standards.
Coordinate activities with external consultants.
Monitor project progress by tracking activities; resolving problems; publishing progress reports; recommending actions.
Requirements :
Must maintain company quality and safety standards.
Must maintain company values Minimum Work Experience / Educational Requirements.
Ability to demonstrate excellent interpersonal and communication skills, both written and verbal.
A Bachelor's degree in Computer Science, Information Systems, or a related field of study.
3+ years of experience in one or more of Applications Engineering or Configuration, Applications Delivery, Software Development, or Software Requirements Analysis.
3 + years of experience in developing and delivering software solutions for an ERP system such as provided by : Sage, SAP, Oracle, Microsoft Dynamics NAV.
Able to demonstrate the experience to independently carry out tasks under the direction of CSA staff.
Able to demonstrate an understanding of FDA 21 CFR Part 11 and related regulations associated with biopharma, pharma, or medical device industries.
Able to demonstrate an understanding of manufacturing best practices like those described in ISPE GPGs.
Ability to comprehend technical information related to biotech equipment, computer and network hardware, and the associated regulatory expectations relating to them.
Ability to work under specific time constraints.
Computer Software Validation Engineer
Applications Engineering or Configuration, Applications Delivery, Software Development, or Software Requirements Analysis. Update or create, application/software/IT use case documents and requirement specifications. Application/software/IT functional specification documents. Independently provide fo...
Computer & Electrical Engineer Software
Expertise in software engineering practices and software lifecycle models. Bachelor's degree from an accredited college or university in engineering or science related field and 4 years of relevant experience; or Master's degree from an accredited college or university in engineering or science rela...
Software Engineer, Computer Vision
As a Staff Software Engineer, Computer Vision you will play a lead role in providing advanced workflow capability with integrated vision recognition, perception and automation which improves speed, feedback, safety, and productivity of our advanced compounding technology. The Staff Software Engineer...
Computer Software Validation Engineer
Applications Engineering or Configuration, Applications Delivery, Software Development, or Software Requirements Analysis. Update or create, application/software/IT use case documents and requirement specifications. Application/software/IT functional specification documents. Commissioning documents ...
Computer & Electrical Engineer Software
Expertise in software engineering practices and software lifecycle models. Bachelor's degree from an accredited college or university in engineering or science related field and 4 years of relevant experience; or Master's degree from an accredited college or university in engineering or science rela...
Windows Software Engineer
Our client, a large defense contractor, has an immediate opening for a Windows Software Engineer to work from their Canonsburg, PA facility. This position will involve the design, development, testing, integration and configuration of software applications and components as well as engineering exper...
Software Engineer, Data Infrastructure - School of Computer Science - CSD
The TEEL Lab at Carnegie Mellon University, is seeking a skilled and motivated Software Engineer to enhance our Information Technology Services team. You'll be leveraging the latest in cloud computing, data pipelines, and backend development technologies, while working in close collaboration with a ...
Software Verification & Validation (V&V) Engineer
Software Verification & Validation (V&V) Engineer. Perform Independent Verification and Validation (IV&V) activities in support of nuclear power plant safety system projects to ensure that the safety system application software meet all intended design requirements. Review safety system functional a...
Senior Software Engineer
We are currently searching for a Senior Software Engineer for a direct-hire hybrid opportunity with our client in the Pittsburgh market. As a Senior Software Engineer, you will be a key part of the motor that drives our client's product line to success. You will collaborate day-to-day with a team of...
Contact Center Quality Assurance Analyst
Contact Center Quality Assurance Analyst. Manager of Contact Center Quality Assurance. Ensures quality, policy, and compliance guidelines are consistently followed on all communication with FNB customers. Analyze the quality of the contact and proper adherence to established company policies, proced...