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Senior CQV Engineer

Katalyst Healthcares and Lifesciences

Montpelier, Vermont • Today

Full-time

Job Details

Skills

Biotechnology
Life Sciences
Regulatory Compliance
URS
IQ
OQ
PQ
IDS
Documentation
Risk Assessment
FMEA
GAMP
Management
Corrective And Preventive Action
Root Cause Analysis
Manufacturing
Quality Assurance
IT Management
Mentorship
Resource Planning
Mechanical Engineering
Electrical Engineering
Biomedicine
Pharmaceutics
Medical Devices
GMP
GxP
Technical Writing
Communication
Leadership
Problem Solving
Conflict Resolution

Summary

Job Description:
We are seeking an experienced Senior CQV Engineer to lead and execute Commissioning, Qualification, and Validation (CQV) activities for pharmaceutical, biotechnology, or life sciences manufacturing facilities. The role will support equipment, utilities, facilities, and manufacturing systems while ensuring compliance with GMP, FDA, GxP, and applicable industry standards.
Responsibilities:

Lead Commissioning, Qualification & Validation (CQV) activities for manufacturing equipment, utilities, facilities, and systems.
Develop and execute URS, DQ, FAT, SAT, IQ, OQ, and PQ documentation and protocols.
Develop CQV plans, validation strategies, protocols, reports, and traceability documentation.
Review engineering specifications, P&IDs, drawings, equipment documentation, and vendor packages.
Coordinate and execute FAT/SAT activities with vendors, Engineering, Quality, and project teams.
Perform equipment and utility qualification activities in accordance with approved procedures.
Develop and execute risk assessments, including FMEA and criticality assessments.
Ensure validation activities are aligned with GMP/GxP, FDA, EU GMP, GAMP 5, and ISPE requirements.
Support commissioning activities and transition systems from construction through qualification and operational readiness.
Manage deviations, discrepancies, change controls, and CAPA associated with CQV activities.
Perform root cause analysis and implement appropriate corrective and preventive actions.
Review and approve test results, qualification packages, and validation reports.
Coordinate with Engineering, Automation, Manufacturing, Quality Assurance, Facilities, and external vendors.
Provide technical leadership and mentoring to junior CQV engineers.
Support project schedules, resource planning, and CQV deliverables.

Requirements:

Bachelor's degree in mechanical, Electrical, Chemical, Biomedical, Pharmaceutical, or related Engineering discipline.
Typically, 7-10+ years of CQV/validation experience in pharmaceutical, biotech, medical device, or other regulated industries.
Strong knowledge of GMP/GxP validation requirements.
Excellent technical writing, communication, leadership, and problem-solving skills.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 6ae48295337e21cade9fede244986fb
Posted 30+ days ago

Fitment

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Lebanon, New Hampshire

•

Today

About the Department Site New Hampshire, located in West Lebanon, is where Novo Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. What we offer you: Leading pay and annual performance bonus for all positions36 Paid days off including vacation, sick days & company holidaysHealth Insurance, Dental Insurance, Vision InsuranceGuarant

Full-time

Senior Engineer, Validation

Maryland

•

Today

About Site Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC's I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., hous

Full-time

USD 120,000.00 - 140,000.00 per year

CQV Engineer

Albany, New York

•

Today

Job Summary: The CQV Engineer is responsible for supporting commissioning and qualification activities for pharmaceutical or biotechnology manufacturing facilities, equipment, utilities, and systems. The role ensures systems are properly commissioned, qualified, documented, and compliant with GMP, FDA, GAMP 5, and applicable regulatory requirements. Key Responsibilities: Develop and execute Commissioning and Qualification (C&Q) documentation and activities. Prepare and execute URS, DQ, IQ, OQ,

Full-time

CQV Engineer

Portland, Maine

•

Today

Summary: Seeking a CQV Validation Engineer with 5+ years of experience in pharmaceutical, biotech, or life sciences. The ideal candidate will have hands-on experience with Commissioning, Qualification & Validation (CQV) for standalone manufacturing equipment in a GMP-regulated environment. Roles & Responsibilities: Perform CQV activities for standalone equipment. Author and execute IQ/OQ/PQ protocols, validation plans, and reports. Support FAT, SAT, commissioning, qualification, and val

Full-time

Job Details

Skills

Biotechnology
Life Sciences
Regulatory Compliance
URS
IQ
OQ
PQ
IDS
Documentation
Risk Assessment
FMEA
GAMP
Management
Corrective And Preventive Action
Root Cause Analysis
Manufacturing
Quality Assurance
IT Management
Mentorship
Resource Planning
Mechanical Engineering
Electrical Engineering
Biomedicine
Pharmaceutics
Medical Devices
GMP
GxP
Technical Writing
Communication
Leadership
Problem Solving
Conflict Resolution

Summary

Lead Commissioning, Qualification & Validation (CQV) activities for manufacturing equipment, utilities, facilities, and systems.
Develop and execute URS, DQ, FAT, SAT, IQ, OQ, and PQ documentation and protocols.
Develop CQV plans, validation strategies, protocols, reports, and traceability documentation.
Review engineering specifications, P&IDs, drawings, equipment documentation, and vendor packages.
Coordinate and execute FAT/SAT activities with vendors, Engineering, Quality, and project teams.
Perform equipment and utility qualification activities in accordance with approved procedures.
Develop and execute risk assessments, including FMEA and criticality assessments.
Ensure validation activities are aligned with GMP/GxP, FDA, EU GMP, GAMP 5, and ISPE requirements.
Support commissioning activities and transition systems from construction through qualification and operational readiness.
Manage deviations, discrepancies, change controls, and CAPA associated with CQV activities.
Perform root cause analysis and implement appropriate corrective and preventive actions.
Review and approve test results, qualification packages, and validation reports.
Coordinate with Engineering, Automation, Manufacturing, Quality Assurance, Facilities, and external vendors.
Provide technical leadership and mentoring to junior CQV engineers.
Support project schedules, resource planning, and CQV deliverables.

Requirements:

Bachelor's degree in mechanical, Electrical, Chemical, Biomedical, Pharmaceutical, or related Engineering discipline.
Typically, 7-10+ years of CQV/validation experience in pharmaceutical, biotech, medical device, or other regulated industries.
Strong knowledge of GMP/GxP validation requirements.
Excellent technical writing, communication, leadership, and problem-solving skills.

Dice Id: 91116760
Position Id: 6ae48295337e21cade9fede244986fb
Posted 30+ days ago

Fitment

Dice Job Match Score™

To see how well you match this job, please log in or create an account.

Once logged in, be sure to complete your profile to get the most accurate match score.

Create job alert

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Lebanon, New Hampshire

•

Today

Full-time

Senior Engineer, Validation

Maryland

•

Today

Full-time

USD 120,000.00 - 140,000.00 per year

CQV Engineer

Albany, New York

•

Today

Full-time

CQV Engineer

Portland, Maine

•

Today

Full-time

Senior CQV Engineer

Skills

Summary

Dice Job Match Score™

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Senior CQV Engineer

Job Details

Skills

Summary

Dice Job Match Score™

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