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Computer System Validation

1 month ago

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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.

Like the look of this opportunity Make sure to apply fast, as a high volume of applications is expected Scroll down to read the complete job description.

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.