CSV Engineer

Location
07901, Summit
Salary
63/hr + medical/dental/vision/401k and PTO
Posted
Jul 20, 2021
Required Education
Bachelors Degree
Position Type
Full time

Piper Companies is currently seeking a CSV Engineer based in Summit, New Jersey for work at a leading pharmaceutical company. The CSV Engineer will interface with both internal customers and external service providers to ensure the proper implementation of manufacturing/laboratory equipment and computerized systems.  

This position has remote flex but the candidate will need to be able to commute to the site on short notice.

Responsibilities of the CSV Engineer:   

  • Responsible for ownership/delivery of all lifecycle deliverables
  • Capable of full body of CSV for single and multi-user computerized systems 
  • Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment  
  • Supervises vendors for qualification functions  

 Qualifications of the CSV Engineer:   

  • 5+ years experience in FDA-regulated industry performing CSV 
  • Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry 
  • Able to draft protocols and test scripts, define validation strategy
  • Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance 
  • Ability to work with the end user to identify and document User and Functional Requirements 
  • BS in Engineering/Computer Science or equivalent  

Compensation for the CSV Engineer:   

  • $60-62/hr 
  • Comprehensive Benefits package: Medical, Dental, Vision, 401K, PTO  

Keywords: GMP, GLP, GXP, GCP, 21 cfr part 11, full-process manufacturing, CSV, Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls, FAT, SIT, final acceptance testing, system integration testing, engineering, computer engineering, protocols, configuring systems, life cycle management