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Contract Method Validation Jobs in Milpitas, CA (NOW HIRING)

Validation Engineer

Cupertino, CA · On-site

$65 - $85/hr

Contribute to evolving wireless characterization methodologies as new cellular technologies emerge ... Type: Contract Duration: 12 months with extension Work Location: Cupertino, CA (onsite) Pay rate ...

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Contract Method Validation information

See Milpitas, CA salary details

$26

$60

$91

How much do contract method validation jobs pay per hour?

As of Sep 6, 2026, the average hourly pay for contract method validation in Milpitas, CA is $60.60, according to ZipRecruiter salary data. Most workers in this role earn between $45.96 and $73.65 per hour, depending on experience, location, and employer.

What is the difference between Contract Method Validation vs Analytical Method Validation?

AspectContract Method ValidationAnalytical Method Validation
PurposeValidates that a contracted method meets specific requirements for a particular project or clientEnsures an analytical method is accurate, reliable, and reproducible for testing purposes
ScopeTypically project-specific, focusing on methods used under contractual agreementsBroader, covering method development, validation, and routine testing
CredentialsOften requires validation expertise, GMP knowledge, and industry-specific certificationsRequires analytical chemistry knowledge, validation experience, and relevant certifications
Work EnvironmentPharmaceutical, biotech, or manufacturing settings with client-specific projectsLaboratories performing routine testing and method development in similar industries

Contract Method Validation focuses on validating methods for specific client projects, while Analytical Method Validation ensures the overall reliability of testing methods used routinely in laboratories. Both roles require similar credentials and work in related environments, but their scope and purpose differ.

What cities near Milpitas, CA are hiring for Contract Method Validation jobs?

Cities near Milpitas, CA with the most Contract Method Validation job openings:

QA Specialist III - Analytical (Small Molecule)

Scorpion Therapeutics

Newark, CA • On-site

$120 - $180/hr

Other

Medical, Life, Retirement

Posted 7 days ago


Job description

Responsibilities
  • Review and approve analytical quality documentation supporting regulatory submissions (INDs, NDAs, amendments, supplements, annual reports).
  • Review and approve batch-related analytical documentation and support product disposition for clinical, registration, commercial, and stability batches.
  • Evaluate analytical records (raw data, lab notebooks, reports, CoAs/CoTs, supporting documentation) for accuracy, completeness, and GMP compliance.
  • Review analytical methods, method validation protocols/reports, method transfers, and associated change controls.
  • Review specifications, specification justifications, and specification revisions.
  • Review document changes (SOPs, specifications, analytical methods, master batch records) for GMP compliance.
  • Support Regulatory Affairs by reviewing manufacturing process, analytical method, and specification changes impacting submissions.
  • Review Quality System records (deviations/OOS/OOT, lab investigations, CAPAs, change controls, risk assessments) for timely completion and compliance.
  • Review and approve stability protocols/reports and stability data; evaluate internal/external stability trend data.
  • Collaborate with CMOs, contract laboratories, Manufacturing, Analytical Development, and Technical Operations to resolve quality issues.
  • Participate in continuous improvement initiatives to enhance analytical quality processes and the Quality System.
Qualifications
  • BS in Chemistry, Pharmaceutical Sciences, Biology, or related field + 5+ years in analytical development, manufacturing, or QA in biotechnology (or equivalent).
  • 3+ years experience in a GMP environment.
  • Preferred: regulatory submission experience (INDs/NDAs/amendments/supplements), CMO/contract laboratory experience, and use of eQMS (Veeva Vault, TrackWise).
  • Experience reviewing analytical methods/validation/transfer, change controls, and stability documentation.
  • Working knowledge of GMP regulations/guidance (FDA, ICH, USP/NF).
  • Experience with drug substance and drug product analytical testing, including troubleshooting.
  • Strong written/verbal communication; organizational/time-management; manage multiple priorities; attention to detail and sound judgment.
  • Proficiency with Microsoft 365, SharePoint, and Veeva.
Benefits
  • 401(k) with generous employer match; 12 weeks paid parental leave; up to 12 weeks living organ and bone marrow leave; health plans; life insurance and disability; flexible time off; annual Winter Holiday shutdown; at least 11 paid holidays.
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