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Commissioning Qualification Validation Cqv Jobs in Rochester, NY

Unifin SAS

Mechanical/Electrical Engineer

Rochester, NY · On-site

... are documented and validated in a formal manner. ExecuteProjects and Tasks to the approved ... commissioning Writing feasibility and line trials, qualification protocols, execution of the tests ...

Unither Pharmaceuticals

Process Engineer

Rochester, NY · On-site

... are documented and validated in a formal manner. Execute Projects andTasks to the approved ... commissioning Serves in an expert role in writing the qualification protocol, execution of the ...

Unifin SAS

Process Engineer

Rochester, NY · On-site

... are documented and validated in a formal manner. Execute Projects andTasks to the approved ... commissioning Serves in an expert role in writing the qualification protocol, execution of the ...

Unifin SAS

Senior Mechanical/Electrical Engineer

Rochester, NY · On-site

$106K - $138K/yr

... commissioning • Serves in an expert role in writing feasibility and line trials, qualification ... and validation requirements. • Ability to work in a matrix organization with cross-functional ...

Unifin SAS

Mechanical/Electrical Engineer

Rochester, NY · On-site

... validated in a formal manner. ExecuteProjects and Tasks to the approved completion deadlines and ... commissioning Writing feasibility and line trials, qualification protocols, execution of the tests ...

Unifin SAS

Process Engineer

Rochester, NY · On-site

... are documented and validated in a formal manner. Execute Projects andTasks to the approved ... commissioning Serves in an expert role in writing the qualification protocol, execution of the ...

Unifin SAS

Lead Mechanical Electrical Engineer

Rochester, NY · On-site

$106K - $129K/yr

... are documented and validated in a formal manner. ExecuteProjects and Tasks to the approved ... commissioning Serves in an expert role in writing the qualification protocol, execution of the ...

Unifin SAS

Lead Mechanical Electrical Engineer

Rochester, NY · On-site

$157K - $164K/yr

... validated in a formal manner. ExecuteProjects and Tasks to the approved completion deadlines and ... commissioning Serves in an expert role in writing the qualification protocol, execution of the ...

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All JobsCommissioning Qualification Validation Cqv JobsCommissioning Qualification Validation Cqv Jobs in Rochester, NY

Commissioning Qualification Validation Cqv information

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How much do commissioning qualification validation cqv jobs pay per hour?

As of Aug 27, 2026, the average hourly pay for commissioning qualification validation cqv in Rochester, NY is $51.30, according to ZipRecruiter salary data. Most workers in this role earn between $38.89 and $62.36 per hour, depending on experience, location, and employer.

What is a commissioning qualification validation (CQV) professional?

Commissioning, Qualification, and Validation (CQV) professionals are specialists who ensure that equipment, systems, and processes in industries like pharmaceuticals, biotechnology, and manufacturing meet regulatory standards and function as intended. They are responsible for planning, executing, and documenting activities that demonstrate compliance with quality and safety regulations. CQV experts play a critical role in bringing new facilities and systems into operation, guaranteeing that everything is tested and verified according to industry guidelines. Their work helps prevent failures, enhance product quality, and ensure patient or consumer safety.

What are some typical challenges faced by commissioning qualification validation (CQV) professionals during facility start-up projects?

CQV professionals often encounter challenges such as tight project timelines, evolving regulatory requirements, and coordination among cross-functional teams. During facility start-up, balancing documentation accuracy with rapid progress can be demanding, especially when unexpected technical issues arise. Additionally, aligning the expectations of engineering, quality assurance, and operations departments requires strong communication and adaptability. By proactively addressing these challenges, CQV professionals help ensure a smooth transition from construction to validated production.

What are the key skills and qualifications needed to thrive as a commissioning qualification validation (CQV) professional, and why are they important?

To excel as a CQV professional, you need a solid background in engineering or life sciences, comprehensive knowledge of Good Manufacturing Practice (GMP), and experience with commissioning and validation processes. Familiarity with industry-standard software like ValGenesis, TrackWise, and documentation management systems, as well as certifications such as ISPE CQV or Six Sigma, is often required. Attention to detail, strong problem-solving abilities, and effective communication are crucial soft skills in this field. These competencies ensure equipment and processes meet regulatory standards, guarantee product quality, and support successful project delivery in highly regulated industries.

What is the difference between Commissioning Qualification Validation Cqv vs Equipment Validation Specialist?

AspectCommissioning Qualification Validation CqvEquipment Validation Specialist
CredentialsGMP, FDA, or industry-specific certificationsGMP, FDA, or industry-specific certifications
Work EnvironmentPharmaceutical, biotech, or manufacturing facilities during project startupManufacturing or laboratory environments focusing on equipment performance
Employer & Industry UsageUsed in regulated industries for system and process validationUsed for validating individual equipment and systems

While both roles involve validation processes, Cqv focuses on the overall commissioning, qualification, and validation of systems and processes during facility startup. Equipment Validation Specialists primarily validate specific equipment performance. Both require similar certifications and work in regulated manufacturing environments, but their scope differs in focus and responsibilities.

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Cities near Rochester, NY with the most Commissioning Qualification Validation Cqv job openings:

Commissioning Qualification Validation Cqv jobs near you

Validation Engineer

Stark Pharma Solutions Inc

Rochester, NY • On-site

Contractor

Re-posted 8 days ago

Job description

Hi,

My name is Sravani Dasari from Stark Pharma Solutions Inc. We are hiring talent for our client and are currently working on a Validation Engineer position. Please send me your updated resume if you have relevant experience and are interested in this opportunity. The detailed job description is as follows.

Job Title: Validation Engineer
Location: Rochester, NY
Duration: Long Term

Position Overview

We are seeking a motivated and detail-oriented Validation Engineer to support validation activities within a GMP-regulated pharmaceutical, biotechnology, or medical device manufacturing environment. This role will be responsible for equipment qualification, process validation, cleaning validation, utility validation, and computerized system validation while ensuring compliance with FDA regulations, cGMP, GAMP 5, and industry standards. The ideal candidate will possess strong technical documentation skills and collaborate effectively with cross-functional teams to support manufacturing and quality operations.

Key Responsibilities

  • Execute Equipment Qualification activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing and laboratory equipment.
  • Develop, review, execute, and maintain validation protocols, test scripts, and final validation reports.
  • Support Process Validation, Cleaning Validation, Utility Validation, and Computer System Validation (CSV) activities.
  • Perform risk assessments using FMEA and support validation lifecycle management.
  • Ensure validation documentation complies with FDA, cGMP, GAMP 5, 21 CFR Part 11, and company quality standards.
  • Investigate validation deviations, support CAPA implementation, and perform root cause analysis.
  • Collaborate with Engineering, Manufacturing, Quality Assurance, Quality Control, and Regulatory Affairs teams to execute validation projects.
  • Review engineering documentation including URS, FS, DS, SOPs, P&IDs, and equipment specifications.
  • Support equipment commissioning, startup, qualification, and process improvement initiatives.
  • Maintain Validation Master Plans (VMP), validation schedules, and project documentation.
  • Participate in internal audits, customer audits, and regulatory inspections.
  • Identify opportunities to improve validation processes, documentation, and compliance activities.

Required Qualifications

  • Bachelor's Degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Pharmaceutical Engineering, or a related engineering discipline.
  • 2+ years of validation experience within the pharmaceutical, biotechnology, or medical device industry.
  • Hands-on experience with Equipment Qualification (IQ/OQ/PQ), Process Validation, Cleaning Validation, Utility Validation, or Computer System Validation (CSV).
  • Strong understanding of FDA regulations, cGMP, GAMP 5, 21 CFR Part 11, and data integrity requirements.
  • Experience developing, executing, and reviewing validation protocols and reports.
  • Familiarity with deviation investigations, CAPA, change control, and risk assessment methodologies.
  • Experience working in GMP-regulated manufacturing environments.
  • Strong technical writing, analytical, and problem-solving skills.
  • Excellent communication and cross-functional collaboration abilities.
  • Experience with validation management systems such as TrackWise, Kneat, Veeva, DeltaV, SCADA, PLC, or similar platforms is preferred.
  • Knowledge of Lean Manufacturing, continuous improvement, and commissioning & qualification (CQV) practices is an added advantage.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates:
https://www.linkedin.com/company/99455976/