US - CQV Consultant
US - CQV Consultant
Posted on :
14-04-2025
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1 Vacancy
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Job Description
Client: Brevitas Corp.
Our Global Company Brevitas Corp. is dedicated to helping organizations achieve tangible results and lasting improvements via successful project delivery continuous process improvement and effective management of change. We serve businesses in a wide range of industries including Pharmaceuticals Food & Beverage Chemicals and Information Technology.
We are looking for highly motivated and energetic individual to join our team as aCQV Consultant in Boston area MA.
This job is located in the United States and only candidates eligible to work in the US for any employer will be considered.
***Travel will be required.
By applying to this job your profile will be considered for upcoming roles within the next 16 monthswhen opportunities do arise.
Responsibilities:
- Write C/Q/V documents following established standards and templates including but not limited to the following:
- CQV Master Plans
- Commissioning Forms
- CQV Protocols and Summary Reports
- Standard Operating Procedures
- Impact Assessments
- Specifications (URS/FRS/DDS)
- FATs/SATs
- Review various protocols executed records and reports that are generated during commissioning (FAT or SAT) validation activities (IQ OQ PQ PV) for process equipment facility and utility systems to ensure compliance with company quality policies and regulatory requirements.
- Able to lead CQV efforts around biopharmaceutical manufacturing including CIP/SIP fermentation and purification systems supporting utilities clean steam and WFI compressed air
- Provide technical assistance during investigations of process /equipment / cleaning / validation issues and aid in the resolution of validation deviations protocol discrepancies and nonconformances
- Provide compliance expertise and leadership for projects involving commissioning qualification and validation of process equipment facility and utility systems.
- Review technical and quality system documents such as SOPs Change Control and Deviation Reports Batch Production Records Technical Manuals P&IDs construction asbuilt flow diagrams as they relate to validation principles and regulatory compliance issues.
- Perform the role of Validation Representative in review of Change Control Requests (CCRs) and CAPA.
- Compile data and prepare reports for completed CQV activities including ETOPs protocol data packages etc.
- Assist in deviation investigation and resolution for problems and issues encountered during field activities.
Qualifications:
- Bachelors Degree in Engineering preferably Chemical or Biotechnology
- High level of familiarity with MS Office package (Project PowerPoint Excel Word)
- 34 years of experience in Pharmaceutical Biotech Medical Device Design Construction Commissioning Validation or QA.
- Experience in writing and of VMP FQ IQ OQ and PQ forms and protocols for GMP Utilities Equipment Systems and Software.
- Must have experience with qualifying clean utilities HVAC System Vaccine production equipment production facilities and environmental validation
- Must have experience with field of functionality testing alarms and safety testing and integrated system testing
- Experience in industrial automation and system controls is a plus
- Individual may be required to execute test or generate test scripts and report or a combination of all activities
To Apply:
- Click the Im interested button below or
- Email your resume in MSWord or pdf format towith the following details in the emailsSubject Line:US CQV Consultant: FIRST NAME LAST NAME.
We thank all applicants in advance; however we will only contact the candidates whose qualifications matchclosely tothe job requirements.
We welcome and encourage applications from people with disabilities.Accommodations areavailable on request for candidates taking part in all aspects of the selection process.
We welcome and encourage applications from people with disabilities.Accommodations areavailable on request for candidates taking part in all aspects of the selection process.
Required Experience:
Contract
Employment Type
Full-Time
Key Skills
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