Automation Validation Engineer
1 month ago
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.
RequirementsResponsibilities 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
- 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
BenefitsWhy 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
We have other current jobs related to this field that you can find below
-
NS2 AIOps and Cloud Automation Engineer
4 days ago
Newtown Square, Pennsylvania, United States SAP Full timeSAP NS2 AIOps and Cloud Automation EngineerSoftware-Design and DevelopmentWe help the world run betterAt SAP, we enable you to bring out your best. Our company culture is focused on collaboration and a shared passion to help the world run better. How? We focus every day on building the foundation for tomorrow and creating a workplace that embraces...
-
NS2 AIOps and Cloud Automation Engineer
1 week ago
Newtown Square, Pennsylvania, United States SAP Full timeWe help the world run better At SAP, we enable you to bring out your best. Our company culture is focused on collaboration and a shared passion to help the world run better. How? We focus every day on building the foundation for tomorrow and creating a workplace that embraces differences, values flexibility, and is aligned to our purpose-driven and...
-
Linux Engineer
4 weeks ago
newtown, United States Motion Recruitment Full timeA forward-thinking SaaS technology firm is seeking a talented Remote Linux Engineer to join their distributed team. As a Remote Linux Engineer, you will play a crucial role in designing, implementing, and maintaining scalable and secure Linux-based infrastructure in the cloud. You will lead efforts to automate deployment, configuration, and management...
-
Linux Engineer
2 weeks ago
Newtown, Pennsylvania, United States Motion Recruitment Partners LLC Full timeA forward-thinking SaaS technology firm is seeking a talented Remote Linux Engineer to join their distributed team.As a Remote Linux Engineer, you will play a crucial role in designing, implementing, and maintaining scalable and secure Linux-based infrastructure in the cloud. You will lead efforts to automate deployment, configuration, and management...
-
Mechatronics Design Engineer
2 weeks ago
Newtown, United States Xyntek Incorporated, a CXV Global Company Full timeJob Description Job Summary: Mechatronics Design Engineer The mechatronics design engineer (mde) is an in-house design and development role supporting the mechanical, electrical, and pneumatic design of all turnkey projects at Xyntek LLC. The mde will support the different business division leads and technology verticals (vision, robotics, serialization,...
-
Lead Mechanical Design Engineer
2 weeks ago
Newtown, United States Xyntek Incorporated, a CXV Global Company Full timeJob DescriptionLead Mechanical Design EngineerThe Lead Mechanical Design Engineer is an in-house design and development role supporting the mechanical and pneumatic design of all turnkey projects at Xyntek LLC. The Lead Mechanical Design Engineer will support the different business division leads and technology verticals (vision, robotics, serialization,...
-
Lead Mechanical Design Engineer
4 weeks ago
Newtown, United States Xyntek Incorporated, a CXV Global Company Full timeJob Description Lead Mechanical Design Engineer The Lead Mechanical Design Engineer is an in-house design and development role supporting the mechanical and pneumatic design of all turnkey projects at Xyntek LLC. The Lead Mechanical Design Engineer will support the different business division leads and technology verticals (vision, robotics, serialization,...
-
Lead Mechanical Design Engineer
3 weeks ago
Newtown, United States Xyntek Incorporated, a CXV Global Company Full timeJob Description Lead Mechanical Design Engineer The Lead Mechanical Design Engineer is an in-house design and development role supporting the mechanical and pneumatic design of all turnkey projects at Xyntek LLC. The Lead Mechanical Design Engineer will support the different business division leads and technology verticals (vision, robotics, serialization,...
-
Mechatronics Design Engineer
4 weeks ago
Newtown, United States Catalyx Full timeJob DescriptionJob DescriptionJob Summary:Mechatronics Design EngineerThe mechatronics design engineer (mde) is an in-house design and development role supporting the mechanical, electrical, and pneumatic design of all turnkey projects at Xyntek LLC. The mde will support the different business division leads and technology verticals (vision, robotics,...
-
Lead Mechanical Design Engineer
1 month ago
Newtown, United States Catalyx Full timeLead Mechanical Design EngineerThe Lead Mechanical Design Engineer is an in-house design and development role supporting the mechanical and pneumatic design of all turnkey projects at Xyntek LLC. The Lead Mechanical Design Engineer will support the different business division leads and technology verticals (vision, robotics, serialization, etc) and work with...
-
Lead Mechanical Design Engineer
4 weeks ago
Newtown, United States Catalyx Full timeJob DescriptionJob DescriptionLead Mechanical Design EngineerThe Lead Mechanical Design Engineer is an in-house design and development role supporting the mechanical and pneumatic design of all turnkey projects at Xyntek LLC. The Lead Mechanical Design Engineer will support the different business division leads and technology verticals (vision, robotics,...
-
Lead Mechanical Design Engineer
4 weeks ago
Newtown, United States Catalyx Full timeLead Mechanical Design EngineerThe Lead Mechanical Design Engineer is an in-house design and development role supporting the mechanical and pneumatic design of all turnkey projects at Xyntek LLC. The Lead Mechanical Design Engineer will support the different business division leads and technology verticals (vision, robotics, serialization, etc) and work with...
-
Network Security Engineer
3 weeks ago
Newtown, United States 4 Staffing Corp Full timeAbout the job Network Security Engineer Job Description:Our client is looking for a highly skilled and experienced Network Security Engineer to join their team. As a Network Security Engineer, you will be responsible for designing, implementing, and maintaining the security infrastructure and practices for our network environment. You will work closely with...
-
Senior Electrical Engineer
2 weeks ago
Newtown, United States The Mason Group Full timeSr Electrical Engineer (Microprocessor-based) We are seeking a seasoned Electrical Engineer, embedded engineer to design and program complex electrical systems. Looking for a place where you can have a direct path to grow, with a growing, stable organization? Giving the opportunity for continuous training & coaching? Where you can be part of a company that...
-
Project Engineer
4 weeks ago
Newtown, United States PKF-Mark III, Inc. Full timeEstablished in 1969, PKF-Mark III, Inc. ("PKF") is an employee-owned corporation, which places substantial emphasis on self-performance to expand and distinguish itself as a premier general contractor with unique engineering, bidding, construction, and management capabilities not available in competitors. PKF's project list includes significant bridge &...
-
Paid Search Engine Marketing
2 weeks ago
Newtown, United States Mediassociates Full time**Position: Paid Search Engine Marketing (SEM), Strategist** **Company: Mediassociates, 75 Glen Road, Sandy Hook, CT 06482** **Overview**: Mediassociates is a leading independent media planning, buying and analytics agency located in Fairfield County, Connecticut. It leverages an approach called Precision Branding to guide brands in planning communication...
-
Project Engineer
4 weeks ago
Newtown, United States PKF-Mark III, Inc. Full timeJob Description About Us: Established in 1969, PKF-Mark III, Inc. ("PKF") is an employee-owned corporation, which places substantial emphasis on self-performance to expand and distinguish itself as a premier general contractor with unique engineering, bidding, construction, and management capabilities not available in competitors. PKF's project list includes...
-
Project Engineer
4 weeks ago
Newtown, United States PKF-Mark III, Inc. Full timeJob Description About Us: Established in 1969, PKF-Mark III, Inc. ("PKF") is an employee-owned corporation, which places substantial emphasis on self-performance to expand and distinguish itself as a premier general contractor with unique engineering, bidding, construction, and management capabilities not available in competitors. PKF's project list includes...
-
NS2 Ariba QA Engineer
7 days ago
Newtown Square, Pennsylvania, United States SAP Full timeWe help the world run better At SAP, we enable you to bring out your best. Our company culture is focused on collaboration and a shared passion to help the world run better. How? We focus every day on building the foundation for tomorrow and creating a workplace that embraces differences, values flexibility, and is aligned to our purpose-driven and...
-
Cloud Engineer
2 weeks ago
Newtown Square, Pennsylvania, United States APN Consulting Full timePN Consulting has an immediate need for a direct client requirement:Job Title: CI/CD ArchitectLocation: Hybrid - Resource is required to be on-site at NS2 Newtown Square, PA office on Wednesdays and other days depending on business needDuration: 1yr +Project:Cloud Platform Engineering Team Job Description:We seek a highly skilled CI/CD Architect to join our...