Novozen Healthcare LLC ยท 14 hours ago
CQV Engineer
New York, United States
Contract
Onsite
Mid LevelNovozen Healthcare LLC is seeking an experienced Fill/Finish Assembly Engineer to support onsite manufacturing operations. This role focuses on the qualification and validation of combination product and auto-injector assembly equipment within a regulated GMP environment.
BlockchainHealth CareInformation TechnologyIT InfrastructurePenetration TestingSoftwareStaffing AgencyWeb Development
Hiring Manager
TARUN KUMAR
Responsibilities
Support qualification and validation activities for Fill/Finish assembly equipment, including auto-injector and combination product assembly systems
Execute and document IQ, OQ, and PQ protocols in compliance with GMP and quality system requirements
Author, review, and execute validation documentation, including protocols, reports, and deviations
Support quality investigations, root cause analysis, and corrective actions related to equipment and processes
Ensure equipment and processes meet regulatory and compliance standards
Provide technical support for equipment that:
Receives filled syringes
Assembles syringes into delivery devices
Performs labeling operations
Collaborate with cross-functional teams to support ongoing and future assembly equipment implementations
Support existing packaging and assembly lines, including two current packaging lines and upcoming assembly equipment
Qualification
Required
Proven experience qualifying Fill/Finish equipment (mandatory)
Hands-on experience with auto-injector assembly equipment
Strong knowledge of equipment validation and qualification (IQ/OQ/PQ)
Solid understanding of GMP, Quality Systems, and compliance investigations
Experience working in a regulated pharmaceutical or medical device manufacturing environment
Preferred
Experience using ValGenesis for validation protocol authoring and execution
Prior experience supporting combination product manufacturing operations
Company
Novozen Healthcare LLC
At Novozen Healthcare, we excel in bridging the gap between academics and industry.
Founded in 2018
201-500 employees
H1B Sponsorship
Novozen Healthcare LLC 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 (47)
2024 (34)
2023 (20)
2022 (1)
Funding
Current Stage
Growth StageLeadership Team
Vijay Kumar
Sr. Recruitment Partner
Company data provided by crunchbase