Validation Specialist
6 days ago
Job Title: Validation Specialist
Location: Summit, NJ (Hybrid)
Hours/Schedule: Monday - Friday; 1st Shift
Type: Contract
Overview
Global Pharma company looking for experienced Validation Specialist to join their growing team. No C2C.
Responsibilities Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE) and Recipe Authoring/Validation.
Ability to work extended hours or a modified work schedule to assist manufacturing operations support model, including 12x7 on-call support rotation
Knowledge of cGMP, GxP, GAMP, and SDLC regulations, including 21CFR part 11 electronic records and electronic signatures, and good documentation practices with the ALCOA+ principles of data integrity, risk-based approaches to validation, Computer Software Assurance (CSA) principles
Understanding the concept of Critical thinking for Computerized Systems
Familiar with the development of CSV documentation (Validation Plans, Requirements, Design / Configuration Specifications, Test Scripts [IQ/OQ/PQ/UAT], Summary Reports, Trace Matrices, SOPs)
Experience with MES infrastructure, ALM and Veeva document/change management systems and middleware WebMethods
With advanced technical document writing and time management skills, including ability to prioritize and manage expectations
Operate effectively and with minimal supervision, within a team or independently, performing projects and related duties
Requirements Bachelor's degree in a life sciences, engineering or technology discipline required
Minimum of 2+ years relevant work experience required preferably in a pharmaceutical manufacturing environment.
An equivalent combination of education, experience and training may substitute.
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
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