What are the responsibilities and job description for the Validation Engineer position at Katalyst Healthcares & Life Sciences?
Roles & Responsibilities :
- Test Stand & LabView experience along with some Manufacturing equipment validations (IQ/OQ /PQ) experience
- Test Engineer that can help qualify Automated Functional Testers.
- Would be responsible for writing all the documentation (requirement| trace matrix| protocols| reports using the Healthcare templates) and executing the validations.
- The code for the testers will be written by an internal resources with whom Candidate would work closely in order to complete the paperwork and qualify the systems.
- Candidate may also help assemble the hardware side of the tester.
- Good To have - Background in Test Stand | LabView that would be a bonus to help debug and trace requirements.
- Qualify automated functional test systems and support troubleshooting.
- Develop and maintain validation documentation| including requirements| trace matrices| test protocols| and reports.
- Execute verification and validation testing| document results| and manage deviations.
- Ensure compliance with internal quality systems and regulatory standards.
- Collaborate with cross functional teams to support product testing and continuous improvement.
- Bachelors degree in Engineering or related discipline.
- Experience in verification validation testing| preferably in medical devices or other regulated industries.
- Familiarity with automated test systems and documentation best practices.
- Strong analytical| documentation| and problem solving skills.
- About Client Medical device customer USP of the Role and Project
- Would be responsible for writing all the documentation (requirement| trace matrix| protocols| reports using this.
- The code for the testers will be written by an internal resources with whom this person would work closely in order to complete the paperwork and qualify the systems.
- They may also help assemble the hardware side of the tester.
- Candidate should have experience as tester development for Manufacturing
- Candidate should have experience with the validations within the MFG environment - IQ| OQ| PQ
- Responsible for writing all the documentation (requirement| trace matrix| protocols| reports using the Healthcare templates) and executing the validations.
- If they have background in Test Stand LabView that would be a bonus to help debug and trace requirements.
- Essential Skills: Functional Testing
- Skills: Functional Testing
- Skills: MFG/PRO Domain (QAD)
- Experience Required: 4-6