Cindavi ยท 17 hours ago
Validation Engineer
Greater Madison Area
Full-time
Onsite
Mid, Senior Level
$75K/yr - $90K/yr
2+ years expCindavi is focused on bringing life-changing therapeutics to market, and they are seeking a Validation Engineer to support validation activities in a commercial manufacturing facility. This role involves developing, executing, and maintaining validation protocols to ensure compliance with regulatory and quality standards in a cGMP environment.
Staffing & Recruiting
Hiring Manager
Alex Doyle
Responsibilities
Develop, execute, and maintain validation protocols and reports aligned with regulatory requirements and project objectives
Lead and contribute to risk assessments related to validation activities
Ensure validation work is performed in accordance with internal validation policies, procedures, and the Master Validation Plan
Coordinate and execute validation activities including IQ, OQ, PQ, requalification, and revalidation of critical systems and utilities
Assist in preparing protocols for process qualification, cleaning validation, equipment commissioning and qualification, and CSV documentation
Review and analyze analytical and physical data generated during validation activities
Author validation and qualification final reports supported by objective evidence and obtain required approvals
Partner with Development, Manufacturing, Engineering, and Quality teams to generate risk management deliverables such as PHAs, SIAs, FMEs, and risk management reports
Work closely with R&D, Quality, Engineering, Manufacturing, and IT teams to align validation activities with project milestones
Qualification
Required
Bachelor's degree in a scientific discipline or equivalent relevant experience
2 to 5+ years of validation experience within pharmaceutical or medical device manufacturing
Strong understanding of validation principles, methodologies, and regulatory requirements
Hands-on experience drafting and executing IQ, OQ, and PQ documentation
Experience working in cGMP-regulated environments
Company
Cindavi
Cindavi is a technical recruiting firm built for engineering and life-sciences companies that cannot afford slow, low-quality hiring.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase