Computer System Validation (CSV) Senior Engineer

Summary: BioPharma Consulting JAD Group is seeking a talented and experienced Computer System Validation (CSV) Senior Engineer to join our team. As a CSV Senior Engineer, you will play a critical role in ensuring compliance with regulatory requirements and industry standards for computerized systems used in pharmaceutical manufacturing processes. You will lead and execute computer system validation activities and provide expertise in CSV best practices.

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 

• 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. 

• Supports regulatory and client audits as CSV subject matter expert. 

• Actively works to establish strong relationships within the group and with other department managers to improve harmonization and effectiveness.   

• Motivates team to be flexible and to respond to planned and unplanned or unanticipated changes with speed and confidence. 

• 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. 

• Thorough 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 and independently at times (author protocol, execute, analyze data, author reports). 

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

Requirements

Qualifications: 

• Master of Science Degree in Computer Science, Life Sciences, Engineering, or similar discipline with three (3) years of experience in computer system validation activities in pharmaceutical, biotechnology, or

• Bachelor of Science Degree in Computer Science, Life Sciences, Engineering, or similar discipline with five (5) years of experience in computer system validation activities in pharmaceutical, biotechnology, or

• Associates of Science Degree in Computer Science, Life Sciences, Engineering, or similar discipline with seven (7) years of experience in computer system validation activities in pharmaceutical, biotechnology,

Preferred Qualifications: 

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