cGMP Validation Engineer (ONSITE)(No C2C/H1B)

Please note that this is a 12+ contract position.

No C2C or H1B. Just available in W2 basis

Position Summary:

Client is seeking two Validation Scientists for a high-impact project supporting operations product support. These contractors will help validate 10–12 critical raw materials used in VITROS MicroSlide manufacturing by assessing replacements for obsolete materials.

This role requires a self-starter with a strong scientific background, comfort in regulated environments, and the ability to work independently and collaboratively with cross-functional teams. A balance of technical writing, change control, data analysis, and limited lab involvement is expected.

Top 3 Skills Client Required:

1. Experience in a cGMP or regulated environment

2. Scientific or technical background

3. Demonstrated independence/self-starting capability

(Academic research or capstone projects count toward experience.)

Qualifications:

Required:

• Bachelor’s degree in Chemistry, Biology, Biotechnology, Chemical Engineering, or related field

• 5–7 years in a regulated environment (FDA, ISO, USDA)

• Prior experience in cGMP or FDA-regulated setting (non-negotiable)

• Familiarity with VITROS MicroSlide technology

• Proven validation experience (minimum 2+ years)

• Strong data analysis and technical writing skills

• Ability to work independently, prioritize, and multitask

Preferred:

• MS or PhD in a scientific field

• Familiarity with:

  • Internal system (or equivalent like Windchill)

  • LIMS, Minitab, Microsoft Office Suite

  • Vitros chemistry analyzers

• Strong bench skills (a plus, but not required)

• Experience with analytical testing, chemical & enzyme validation

Tools & Systems:

• LIMS (Laboratory Information Management System)

• Minitab for statistical/data analysis

• Windchill (for change control)

• Microsoft Office Suite

Work Breakdown:

• 80%: Desk-based work (documentation, meetings, data analysis)

• 20%: Lab/factory floor (observational work, process oversight, hands-on feasibility testing if applicable)

Additional Notes:

• Project-based contract – not intended to convert to FTE

• Candidates with parallel validation experience in pharma or medical devices are welcome

• Retirees or industry veterans returning for contract work may qualify for top-end pay

• Manager is flexible on credentials if experience aligns with skill needs

Primary Responsibilities:

• Lead multiple validation projects concurrently with minimal supervision

• Write validation plans, protocols, and reports

• Design and execute feasibility studies and risk assessments (e.g., FMEA, FMECA, Hazard Analysis)

• Support implementation of validated materials into production workflows

• Collaborate with investigational lab teams on test designs and performance testing

• Analyze data from chemical/enzyme analytical testing and pilot product testing

• Document findings and provide recommendations for fitness for use

• Prepare change control documentation and verification plans

Applicants must provide their phone number. Reference job number is A4911