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Lead CQV Engineer / Lead Validation Engineer
Accepting applicationsJobs via Dice · Harvard, MA
Full-Time Senior aiarmaterf
Posted
1d ago
Category
Test
Experience
Senior
Country
United States
Dice is the leading career destination for tech experts at every stage of their careers. Our client, Algo Soft Solutions LLC, is seeking the following. Apply via Dice today!
Lead CQV Engineer / Lead Validation Engineer
Introduction:
This position is for a Lead CQV Engineer or Lead Validation Engineer who will be responsible for leading second shift CQV execution activities across multiple systems and workstreams. The individual will coordinate daily execution priorities, interface with various departments to resolve issues in real time, oversee the execution of protocols, and support validation activities.
Responsibilities:
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
Support and review:
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:
Required Skills:
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)
Additional Requirements:
This role is for 2nd shift. Must be able to work second shift (2-10 PM EST) and weekends
This role requires the ability to be on-site, full-time in Devens, MA
Show more Show less
Lead CQV Engineer / Lead Validation Engineer
Introduction:
This position is for a Lead CQV Engineer or Lead Validation Engineer who will be responsible for leading second shift CQV execution activities across multiple systems and workstreams. The individual will coordinate daily execution priorities, interface with various departments to resolve issues in real time, oversee the execution of protocols, and support validation activities.
Responsibilities:
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
Support and review:
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:
Required Skills:
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)
Additional Requirements:
This role is for 2nd shift. Must be able to work second shift (2-10 PM EST) and weekends
This role requires the ability to be on-site, full-time in Devens, MA
Show more Show less