Job Posting: Commissioning Qualification and Validation (CQV)
Duration: 3 to 6 months, Initial Term
Employment Type: ICQ W2
Location: Greater Boston Area
EDUCATION & EXPERIENCE REQUIREMENTS
B.S. degree in Biology, Biochemistry, Chemistry, Engineering or equivalent years’ experience working in FDA-regulated industries within the areas of Validation, Quality, Manufacturing and/or Engineering.
- 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.
GENERAL DESIRED SKILLS AND 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.
DESIRED SKILLS AND EXPERIENCE
- 2 to 6 years of Commissioning, Qualification and/or Validation (CQV) with experience in Bio-process manufacturing operations.
- Experience writing protocols, performing execution for process equipment used in manufacturing, troubleshooting or mitigation of discrepancies. Background or history with single use technologies is preferred.
- Direct experience providing technical assessments within the following Quality Systems; deviations, risk assessments, CAPAs, GMP investigation and change controls, assessing proposed changes to validation process to identify requirements necessary to maintain validation status.
- Experience developing all aspects of commissioning, qualification and/or validation documentation including but not limited to Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation, Operational and/or Performance Qualification (IQ, OQ and PQ) protocols and final summary reports.
- Decommissioning, Change Management, Commissioning, Validation.
Please note that only local candidates will be considered.
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