What are the responsibilities and job description for the Validation Specialist position at System One?
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
Requirements
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.
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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