Computer System Validation (CSV) Engineer -Pharma (Hybrid, Summit, NJ)

We are seeking a Computer System Validation (CSV) Engineer for a global pharmaceutical client. You will support the successful implementation of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. Contributes to the completion of milestones associated with equipment qualification and systems validation.

This is a 40-hour per-week, 12-month contract (extensions possible), 50% onsite role in Summit, NJ

This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.

Responsibilities

• Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures.
• Develops protocols and associated reports while adhering to a change management process.
• Supports the execution of equipment qualifications and validation protocols
• Supports equipment qualification and systems validation activities.
• Configures and documents the configuration of computerized systems
• Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.
• Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
• Independent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized System
• Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates. Supervises vendors for qualification functions.
• Completes all qualification and validation documentation with accuracy, completeness and compliance to Company standards. Provides excellent customer service and support.
• Regularly reviews, prioritizes and promptly responds to customer equipment qualification and support requests.
• Provides technical support and guidance on calibration and equipment qualification issues. Interfaces with customers to ensure all expectations are being met.
  
  

Requirements

• 5+ years of experience in the FDA-regulated industry and CSV Computer system validation.
• 5+ years of experience in 21CFR P11 compliance regulations and knowledge of ISPE guidance
• Experience in troubleshooting issues related to computer systems validation. Experience executing equipment qualification documents
• Experience working on deviations. Good understanding of Audit Trail
• Strong working knowledge of MS Windows client and server technologies.
• Strong computer skills in Microsoft Office Suite – Word, Excel, Visio and Outlook.
• Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry
• Knowledge of Pharmaceutical laboratory and manufacturing systems.
• BS degree in Engineering / Computer Science or any related field is required
  
  

Please submit your resume to our network at https://www.stage4solutions.com/careers/ (please apply to the Computer System Validation (CSV) Engineer -Pharma (Hybrid, Summit, NJ) role).

Please feel free to forward this project opening to others who may be interested.

Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates’ qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.

Compensation: $85/hr. - $88.56/hr.