Summary:

We are looking for a Validation Engineer for an immediate start. In this position you will plan, write, implement, and review CSV documents related to the onboarding and validation of new and existing QC Systems. This is a very dynamic and fast-paced environment located in New Jersey. The candidate is expected to multi-task, communicate effectively, and possess a strong work ethic.

Responsibilities

• Ensure vendor qualification documentation are pre-approved by required stakeholders prior to execution
• Facilitate vendor qualification of instrumentation
• Draft qualification documentation for equipment and analytical instruments including System Impact Assessments (SIA), GxP assessments, System Risk Assessments (SRA), User Requirement Specifications (URS), Installation and Operational and Performance Qualification Documentation (IOQ or IOPQ Trace Matrix (TM), and/or Summary Reports (SR)
• Draft IQ and OQ Test Scripts
• Provide support and/or execute IQ/OQ/PQ Protocols
• Translate system requirement specifications into executable validation protocols
• Write reports summarizing system validation
• Attend update meetings and provide status updates of current projects
• Work with cross functional teams, system owners and stakeholders to review and approve documentation
• Work with Information technology (IT) team to secure workstations, provide access to vendors, add software systems to domain and administration support
• Will need to engage with team members across company networks which span multiple locations within the U.S.
• Will work collaboratively with other colleagues and functions within the Client network

Education and Experience

• Bachelor's Degree in Chemistry, Biology, Microbiology or a related field preferred
• QC, cGMP, GAMP 5, Biotechnology, and/or Pharmaceutical experience is preferred
• Computer Systems Validation (CSV) experience required

Functional Requirements

• Knowledge and understanding of GAMP 5, 21 CFR Part 11, Computer System Validation and Quality Management System
• Working knowledge of Microsoft Office Applications
• Strong understanding of good manufacturing practices and/or good laboratory practices
• Working Knowledge of 21 CFR Part 11 compliance in a GMP/GLP regulated industry, Data Integrity, GDP and adherence to ALCOA principles