Validation Engineer

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description

Mandatory Technical Skills:

1. Experience as a Verification and Validation Engineer for 5+ years.
2. XRAY/Product testing experience (System Testing experience mandatory).
3. Strong knowledge of Microsoft Windows technologies.
4. Strong working experience on setting up lab test equipment and setting up PC and Servers and deploying software onto target systems.
5. Knowledge of FDA regulations required to test medical products.
6. Expertise in quality reviews.

Desirable Technical Skills:

1. Prepared, reviewed, executed and summarized validation protocols.
2. Provided validation support for the review to ensure designs comply with current validation standards and are able to be adequately validated and maintained within validated control.
3. Experienced in Agile methodologies, Manual Testing, White Box and Black Box Testing, Validation and Verification testing.
4. Experienced in testing Software, Web Applications, IVR, System Components, and Database.
5. Experienced in System Performance, Unit, Functional, Regression, Integration and User Acceptance Testing.
6. Participated in writing and implementing Test Plans, Test Cases and Test Scripts/Protocols and Traceability Matrix. Executed Test Scripts/Protocols and documented Test Results. Edited and re-tested Test Scripts/Protocols and signed off (Pass/Fail).
7. Hands-on experienced in Automated Test Tool – Mercury Win Runner, Load Runner and Test Director.
8. Created defect tracking (manual repository), maintained and updated defect statuses and timelines.
9. Complaints Investigation for Medical Device (CAPA).

Mandatory Functional Skills:

1. Create and revise Design Verification and Validation (V&V) Procedures.
2. Participate in Design Verification and Validation Procedure Reviews.
3. Setup and configure Test Equipment.
4. Perform dry runs and formal Verification and Validation (V&V) activities as required.
5. Perform dry runs for formal Usability test activities as required.
6. Perform remediations of V&V results as required.
7. Record and close defects found during V&V activities.

• Served as a technical resource for assessing validation requirements, solving test related problems, and developing strategies for problem prevention.

• Provided validation support for the review to ensure designs comply with current validation standards and are able to be adequately validated and maintained within validated control.

Understanding of healthcare environment. Experience in a medical device or pharmaceutical industry testing. Quality reviewer in verification and validation.

Additional Information

All your information will be kept confidential according to EEO guidelines.