CQV Engineer jobs in United States
cer-icon
Apply on Employer Site
company-logo

PharmEng Technology ยท 11 hours ago

CQV Engineer

positionNew Jersey, United States
timeFull-time
remoteOnsite
senioritySenior Level
date5+ years exp

PharmEng Technology is seeking an experienced CQV Lead to oversee commissioning, qualification, and validation activities in a GMP-regulated pharmaceutical environment. This role is critical for ensuring compliance with regulatory requirements and internal quality standards for process equipment and laboratory systems.

ConsultingInformation TechnologyPharmaceutical
check
H1B Sponsor Likelynote

Responsibilities

Lead CQV efforts for new and existing process equipment and lab instruments/systems, ensuring compliance with cGMP, FDA, EMA, and ICH guidelines
Develop and review CQV documentation including URS, DQ, IQ, OQ, PQ protocols and reports
Coordinate and oversee commissioning activities, including FAT and SAT, and ensure proper transition to qualification
Perform risk assessments (e.g., impact assessments, component criticality analysis) to define qualification scope
Collaborate with Engineering, Quality Assurance, Manufacturing, and Validation teams to ensure project alignment
Support lab system validation including analytical instruments, data integrity, and computerized system validation (CSV), where applicable
Troubleshoot and resolve CQV-related issues and deviations
Participate in regulatory audits and inspections; provide SME-level support on equipment and lab validation topics
Maintain up-to-date knowledge of validation regulations, industry best practices, and technological advancements

Qualification

CQV experienceGMP regulationsQualification protocolsAnalytical lab equipmentProject managementCommunication skillsOrganizational skillsWork independently

Required

Bachelors degree in Engineering, Life Sciences, or related technical discipline (Masters preferred)
5+ years of experience in CQV within the pharmaceutical/biotech industry, with a strong focus on process equipment and lab systems
Solid understanding of GMP regulations, GAMP 5, 21 CFR Part 11, and other relevant guidelines
Proven experience in writing and executing qualification protocols
Familiarity with analytical lab equipment (HPLCs, GCs, incubators, etc.) and CSV principles
Excellent project management, organizational, and communication skills
Ability to work independently and manage multiple priorities in a fast-paced environment

Preferred

Experience with clean utilities (e.g., WFI, clean steam, HVAC) and process support systems
Knowledge of MES, LIMS, or other laboratory management systems
Previous experience in greenfield or brownfield facility start-up projects

Company

PharmEng Technology

twittertwittertwitter
company-logo
PharmEng Technology is a pharmaceutical company that provides consultancy services.
dateFounded in 1997
location
Toronto, Ontario, CAN
people-size201-500 employees
web-link
http://pharmeng.com

H1B Sponsorship

PharmEng Technology has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
2023 (1)
2022 (1)

Funding

Current Stage
Growth Stage

Leadership Team

leader-logo
Alan Kwong
Managing Director & CEO
linkedin
Company data provided by crunchbase