Sr. Validation Engineer

Please send the resumes to careers@starkassociatesllc.com or

Contact: +1 848-300-0022

Job Title : Validation Engineer

Location : Austin, TX

Duration : 6+ Months

Job Description:

• Strong knowledge on the SDLC process

• Knowledge on the Audit controls, GxP standards, electronic approvals

• Authorship of the SDLC deliverables

• Understanding of the Change Management process

Requirements

• • SDLC Compliance Review, Approvals and Validation

• • Review all the project deliverables in accordance to Merck SDLC 2.0

• • Understand the Merck SDLC policies/procedures/templates and Coach the project teams (Business, IT and Testing teams) to use the correct templates/SDLC processes

• • Review the SIT/UAT test cases and conduct pre and post approvals of the test cases

• • Conduct Quality Gate Audits at the end of each phase

• • Review/Approve the Change Requests

• • Author/Support authoring of SDLC documents (QAP, QASR, SIT Test Plan, SIT Test Summary, UAT Test Plan, UAT Test Summary)

• • Perform periodic evaluation of validated/qualified state of systems

• • Provide proactive advice, guidance and support on compliance and quality requirements to the support teams.