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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 3 hours ago

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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 3 hours ago

Fitment

Dice Job Match Score™

🔢 Crunching numbers...

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