Job Summary: Catalyx is seeking entrepreneurial, dedicated, and motivated engineers that are interested in joining a fast-paced engineering team. The ideal candidate will be involved in all aspects of validation and qualification activities as part of an overall System Development Lifecycle (SDLC) approach.
Requirements
Responsibilities and Duties: The Automation Validation Engineer will provide validation and compliance project support to different business divisions and technology verticals (serialization, general automation, machine vision, robotics, etc.) with the following:
Developing and managing GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), User Acceptance Testing, Requirements Traceability Matrix, Validation Summary Reports, Standard Operating Procedures, Change Control Documentation, and Risk Assessment reports
Writing and executing IQ and OQ protocols
Communicating with vendors to ensure project requirements are being met
Managing and coordinating all aspects of the validation activities, including project planning, developing validation strategies, document development and document reviews Overseeing system change requests and associated documentation
Maintaining SOPs pertaining to the Quality Management System Utilizing a risk-based approach (GAMP5) to determine the validation requirements Configuration specifications generation detailing the specific configuration of the systems/interfaces Project change control implementation in accordance with requirements, design, and system changes Identification of risks and clear communication to project stakeholders Maintain, build, and grow existing relationships with current clients, prospective clients, vendors, and partners in accordance with project requirements
Requirements:
Minimum of Bachelor’s degree preferably in Chemical Engineering but Mechanical Engineering, Electrical Engineering, Computer Engineering, Industrial Engineering, or related also considered
Excellent technical writing and communication skills
Experience in the Life Sciences, Pharmaceutical, Medical Devices industries preferred
Experience in systems validation/QA within FDA (GxP) regulated environments preferred
Experience with industrial process validation essential
Ideally, experience with equipment validation, instrument validation, and packaging validation is preferred
Experience with validating and qualifying various software and IT systems utilized in the industrial automation environment
Experience in developing full validation lifecycle documentation and testing protocols (IQ/OQ/PQ/) with thorough knowledge of GAMP5 concepts
Experience of validating a serialization or track & trace systems preferred
Benefits
Why Join Catalyx?
At Catalyx we understand that our people are our greatest asset and are an integral part of our success. For this reason and many others, we take care of our people. The team in Catalyx benefits from a Total Rewards package. This includes excellent personal benefits, competitive salaries, a high-energy work environment, professional growth opportunities, and much more!
An example of what is offered to our team members is as follows:
Competitive compensation with technical & management growth tracks
Annual performance-based raises and bonuses
401(k) savings plan(s) with company matching.
Paid Time Off Packages Medical, Dental, Life, Short & Long-Term Disability benefits
A structured approach to career and professional development opportunities
Sponsored professional events & training programs...and more!
Catalyx is an equal opportunity employer with a strong commitment to supporting and retaining a diverse and talented workforce.
