29 days old

CSV Engineer

ICQ Consultants Corp
Southborough, Massachusetts 01745
  • Job Type
    Employee
  • Job Status
    Full Time
  • Shift
    1st Shift, Overtime

The candidate will be a part of the ICQ Consultants team and will be responsible for the development and execution of protocols (IQ, OQ, PQ) and final summary reports for Computer System Validation (CSV) activities with a focus on data integrity. Additional general Commissioning, Qualification, and Validation experience may be required. 

EDUCATION & EXPERIENCE REQUIREMENTS

B.S. degree in Biology, Biochemistry, Chemistry, Engineering or equivalent years’ experience working in FDA-regulated industries.

RESPONSIBILITIES

  • Successfully working within a multi-disciplinary team coordinating and delivering project activities meeting schedule, budgetary and quality expectations of the client.
  • Customarily and regularly exercises discretionary and independent judgment in performing the job.
  • Participate in training to ensure continued accreditation.
  • Maintain a safe working environment for self, team members and clients operational or administrative staff.
  • Other tasks in alignment with your skills and competencies as required by the project, client and/or management.

Requirements

REQUIRED EXPERIENCE

  • Must have excellent organizational, verbal and written communication skills; with demonstrated ability to efficiently and effectively communicate with cross-functional teams and management on recommended course of action, with minimal assistance.
  • Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint) and MS Project (as needed).
  • Must be a self-starter, detail oriented and able to work independently with minimal supervision.
  • Excellent troubleshooting skills; ability to react quickly to understand and solve problems.

REQUIRED SKILLS

  • Minimum of 2 years of Commissioning, Qualification and/or Validation (CQV) with experience in Bio-process manufacturing operations.
  • Experience writing protocols, performing execution for processes, equipment and utilities used in the Biotech or Pharmaceutical Industry.
  • Direct experience within three or more of the following areas:
    • Computer System Validation
    • Data Integrity
    • 21 CFR Part 11 Compliance
    • Analytical Instrument Qualification
    • Equipment CSV Assessments
    • Factory Acceptance Testing (FAT)
    • Site Acceptance Testing (SAT)
    • Commissioning
    • Installation, Operational and/or Performance Qualification (IQ, OQ and PQ) protocols
    • Data Analysis
    • Deviations

Categories

Posted: 2022-10-28 Expires: 2022-11-27

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CSV Engineer

ICQ Consultants Corp
Southborough, Massachusetts 01745

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