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Lead CQV Engineer

Katalyst Healthcares and Lifesciences

Concord, New Hampshire • 2d ago

Full-time

Job Details

Skills

Quality Assurance
Real-time
Management
IQ
OQ
Drawing
SIP
Documentation
Auditing
Biomedical Engineering
Chemical Engineering
Pharmaceutics
Chromatography
GMP
GDP
Mapping
Project Management
Performance Management
Preventive Maintenance

Summary

Job Description:

Lead second shift CQV execution activities across multiple systems and workstreams
Coordinate daily execution priorities to recover schedule slippage and maintain timelines
Interface with QA, Engineering, and Operations to resolve issues in real time
Oversee execution of IQ/OQ protocols and operational verification activities

Responsibilities:

Drawing walkdowns
Equipment and component verification
Materials of Construction (MOC) and weld verification
Provide oversight for temperature mapping and validation activities
Support SIP/CIP and related cycle development activities as needed
Ensure all documentation meets GMP/GDP and audit-ready standards
Drive deviation identification, escalation, and resolution

Requirements:

Bachelor's Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred)
8+ years of CQV/validation experience in pharma or biotech
Strong hands-on execution background with process equipment (bioreactors, filtration, chromatography, UF)
Proven experience leading validation teams or shift-based execution efforts
Strong GMP/GDP knowledge
Experience with eVal (required), ValGenesis a plus
Experience with temperature mapping (Ellab a plus)
This role is for 2nd shift. Must be able to work second shift (2-10 PM EST) and weekends

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: 8d2d4e038c8716763d2660b980f39182
Posted 30+ days ago

Fitment

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Job Details

Skills

Quality Assurance
Real-time
Management
IQ
OQ
Drawing
SIP
Documentation
Auditing
Biomedical Engineering
Chemical Engineering
Pharmaceutics
Chromatography
GMP
GDP
Mapping
Project Management
Performance Management
Preventive Maintenance

Summary

Job Description:

Lead second shift CQV execution activities across multiple systems and workstreams
Coordinate daily execution priorities to recover schedule slippage and maintain timelines
Interface with QA, Engineering, and Operations to resolve issues in real time
Oversee execution of IQ/OQ protocols and operational verification activities

Responsibilities:

Drawing walkdowns
Equipment and component verification
Materials of Construction (MOC) and weld verification
Provide oversight for temperature mapping and validation activities
Support SIP/CIP and related cycle development activities as needed
Ensure all documentation meets GMP/GDP and audit-ready standards
Drive deviation identification, escalation, and resolution

Requirements:

Bachelor's Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred)
8+ years of CQV/validation experience in pharma or biotech
Strong hands-on execution background with process equipment (bioreactors, filtration, chromatography, UF)
Proven experience leading validation teams or shift-based execution efforts
Strong GMP/GDP knowledge
Experience with eVal (required), ValGenesis a plus
Experience with temperature mapping (Ellab a plus)
This role is for 2nd shift. Must be able to work second shift (2-10 PM EST) and weekends

Dice Id: 91116760
Position Id: 8d2d4e038c8716763d2660b980f39182
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

Never miss an opportunity! Create an alert based on the job you applied for.

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