Emerge · 5 days ago
Contract Methods Validation Specialist
Commerce City, CO
Contract
Onsite
Mid, Senior Level
$60/hr - $65/hrEmerge is seeking an experienced Methods Validation Specialist to support time-critical method validation and verification activities within a GMP-regulated environment. This role will focus on Container Closure Integrity Testing, USP compendial particulate matter, and Antimicrobial Effectiveness Testing across multiple product lines.
Business DevelopmentInformation TechnologyMarketingSales
Responsibilities
Lead Container Closure Integrity Testing (CCIT) method validation using existing instrumentation; partner with an external vendor on recipe finalization and validation documentation
Execute USP Particulate Matter method verification (Chapter II / operator visual inspection) to support release testing across multiple product lines
Develop and execute full Antimicrobial Effectiveness Test (AET) validations for multiple product families
Author and review validation protocols, reports, and supporting GMP documentation
Collaborate cross-functionally with QA, vendors, and internal stakeholders to meet aggressive timelines
Qualification
Required
Bachelor's degree preferably in Analytical Chemistry or Biochemistry
Hands-on experience with method validation and/or verification in a GMP environment
Direct experience with vacuum decay CCIT validation
Strong knowledge of USP compendial methods and regulatory expectations
Experience supporting multiple product lines simultaneously
Ability to work independently, prioritize effectively, and deliver under tight deadlines
Preferred
Familiarity with vendor-developed or transferred methods
Background in analytical method development and method validation
Senior-level scientist or consultant mindset; minimal ramp-up required
Company
Emerge
Emerge global tech enabled managed business service outsourcing company that extend sales, marketing and IT for companies worldwide.
Founded in 2012
501-1000 employees
H1B Sponsorship
Emerge has a track record of offering H1B sponsorships. Please note that this does not
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Trends of Total Sponsorships
2025 (1)
2022 (1)
2021 (1)
Funding
Current Stage
Late StageLeadership Team
Leo Linder
Founder & CEO at Emerge
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