Computer System Validation (CSV) Engineer III

Summary: BioPharma Consulting JAD Group is seeking a Computer System Validation (CSV) Engineer III to join our team. As a CSV Engineer III, you will be responsible for ensuring compliance with regulatory requirements and industry standards for computerized systems used in pharmaceutical manufacturing processes. You will work closely with cross-functional teams to plan and execute computer system validation activities and ensure the integrity of data generated by these systems.

Functions: 

• Generate, obtain approvals, and execute validation deliverables for computerized systems and relevant infrastructure, including Validation Plans, Requirements Specification, Risk Assessments, Installation/Operational Qualifications, Traceability Matrices, and Validation Final Reports, ensuring documents meet regulatory and procedural requirements of 21 CFR Part-11, Annex-11 Data Integrity and GAMP5 among others. 

• Plan and organize validation activities amongst cross functional groups; capable of providing and maintaining status updates for validation activities related to day-to-day operations or project work 

• Able to work independently with minimum guidance from Sr. Engineers and/or CSV Manager (author protocol, execute, analyze data, author reports). 

• Must be able to review all System Delivery Life Cycle (SDLC) deliverables, provide constructive feedback, and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs). 

• Must be able to create, review, and update SOPs, forms, templates, documentation and files. 

• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable laws, regulation, and industry codes.  

• Perform other duties as assigned. 

Required Skills & Abilities: 

• Working knowledge of engineering principles. 

• Working knowledge and expertise in computerized systems validation.  

• Computer System Validation experience with DCS, SCADA and BMS systems such as DeltaV, Factory Talk View, Desigo, Unicorn, Wonderware is preferred. 

• Knowledge of 21 CFR Part 11, Annex 11, Data Integrity, GAMP5 requirements and FDA industry regulations. 

• Excellent written and oral communication skills. 

• Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, Power Point). 

• Ability to work with minimal supervision. 

• Desire to work in fast-paced, state of the art, alternately research and customized manufacturing facility.  

Requirements

Qualifications: 

• Master’s Degree with two (2) years of direct experience in Validation in a pharmaceutical, biotechnology, or
• Bachelor’s Degree with four (4) years of direct experience in Validation in a pharmaceutical, biotechnology, or
• Associate's Degree with six (6) years of direct experience in Validation in a pharmaceutical, biotechnology

Preferred Qualifications: 

• Knowledge of DeltaV automation platform. 
• Experience preferably in FDA-regulated environments.