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.
Please note that only local candidates will be considered.
Apply online with the ICQ applicant sourcing platform. This platform is an engineered program designed to improve the candidate sourcing process, and will ultimately provide value to our employees, prospective candidates and clients alike.
Our Applicant Sourcing Platform provides direct access for candidates to seamlessly search for jobs, identify their industry specific skills and competencies, apply for jobs, and review their application status through the entire sourcing process.
The ICQ Applicant Sourcing Platform and associated career portal provides so many benefits to our candidates:
- Automatic Job Notifications once the portal matches your skills and competencies to any of the jobs posted.
- Increased Flexibility is provided since you can identify your availability and the system will notify you prior to that time to request updated profile information.
- Increased Visibility and Exposure to all open positions and clients. Clients can view reports with your qualifications that match their job requirements.
- Transparent Process lets the candidate track their job application throughout the entire process.
- Register with ICQ and create your profile
- Login to your profile
- View all current job openings
- Complete our custom skills matrix
Join our network, follow us, like us and share this on LinkedIn, Google +, Twitter and Facebook so you can see other new and exciting news and discussions being posted by ICQ Consultants. Or visit our website and get and in depth view of what we are all about: http://icqconsultants.com.