Katalyst CRO ยท 2 months ago
CQV Engineer
Boston, MA
Contract
Onsite
Mid LevelKatalyst CRO is a company focused on providing contract research organization services, and they are seeking a CQV Engineer. The role involves generating and executing validation protocols, managing project validation plans, and ensuring compliance with qualification standards.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Generate, execute, review, finalize, and approve validation/qualification protocols and reports
Manage and update project validation plans for specific projects
Assist and deliver amendments to the qualification(s) to ensure qualification compliance within agreed upon timelines
Utilize computerized asset management system for managing validation/qualification schedules
Generate operational and maintenance SOPs, FATs, URSs, FRSs, validation protocols and reports
Qualification
Required
Bachelor's degree required; B.S. in engineering preferred
Experience in an Engineering or a closely related role in a manufacturing or R&D environment
Experience in a GMP environment required
Experience in a Validation Engineering role generating and executing
Commissioning, Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) protocols
Preferred
B.S. in engineering preferred
Experience in the pharmaceutical/API/chemical manufacturing industry preferred
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO 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
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
Company data provided by crunchbase