Junior CSV Engineer (GxP, SDLC, SAP, Jira, etc.) - Global Pharmaceutical Company : Job Details

Job Details:

Junior CSV/Validation Engineer

Global Pharmaceutical Company

Raritan, NJ – onsite 2-3 days a week

Long Term Contract

looking for junior/lower level consultants who want a great opportunity to learn and get in the door at a major global pharma company

exp with acquisitions and divestitures is a huge plus!

CSV/Validation Engineer

Some of the high level requirements for this role are - consultant with strong knowledge of GxP and Computer System Validation.

Expertise in authoring and reviewing all CSV validation deliverables. Proficient in Compliance Plan, User Stories, Testing, Traceability Matrix and SDLC lifecycle activities.

Knowledge in utilizing SDLC tools such as JIRA, AM, qTest, X-ray etc. Knowledge of Cloud Based qualification and validation, CI/CD methodology, Jenkins and Bitbucket usage preferred. Experience with Backup & Restore GxP activities preferred. Proficient knowledge on CFR Part 11 regulations and Quality Management Regulations.

Expertise in SOP and WI authoring and reviews. Proficient with change control management and utilization. Prefer an individual with great communication skills, ability to work proactively and independently.

Ability to interact and lead conversations and meeting with Business Partners independently to lead and guide GxP policies and regulations.

Interact with technology partners to ensure compliant working and operation of supported GxP systems.