Validation Engineer - GMP - HPLC- FDA Compliance in Des Plaines, Illinois

Collabera Technologies Full-time

Location

Des Plaines, Illinois

Job Type

Full-time

Company

Collabera Technologies

Job Description

Description • Home • Search Jobs • Validation Engineer - GMP - HPLC- FDA Compliance

Contract: Des Plaines, Illinois, US

Salary Range: 30.00 - 37.00 | Per Hour

Job Code: 369111

End Date: 2026-06-03 Days Left: 29 days, 6 hours left

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Position Details:Position Details:

Industry: Pharmaceutical/Biotechnology Job Title: Validation Engineer IV (Pharma/Medical Device | GMP, HPLC, FDA Compliance) Duration: 6 Months Contract (Possible Extension Based on Performance and Business Needs) Location: Des Plaines, IL 60018 Shift: Monday-Friday | 8 Hours per Day | Standard Business Hours Number of Positions Needed: 1 Pay Range : $30.00 to $37.00 per hour

Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success for assuring high product quality and meeting business needs.

Main Responsibilities: • Works with a cross functional team to review qualification and validation documents which meet regulatory requirements. • Supports the complete qualification and validation process to implement new manufacturing FUE and automation, process, test method validations in support of a manufacturing expansion. • Especially in HPLC synthesis, purification and testing. • Supports on-market change control projects. Minimum Requirements: • Bachelor's degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience. • At least 5 years work experience in Quality or related field experience. • Has a history of completing successful projects and driving positive compliance outcomes. Preferred Qualifications: • Bachelor's or master's degree in one of the following Engineering disciplines: Chemical, Electrical, Bio-medical, or Mechanical. • 5+ years of relative professional work experience in Medical Device Quality/Pharmaceutical or in a regulated industry. • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971. • Strong technical writing skills. • Polished verbal and written communication skills. Additional Information: • Supports manufacturing expansion activities. • Involvement in HPLC synthesis, purification, and testing. • Engagement in change control projects. Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - These all are subject to applicable eligibility).

Job Requirement • Validation • Qualification • GMP • FDA • ISO13485 • ISO14971 • Compliance • HPLC • Synthesis • Purification • Testing • Automation • Manufacturing • ChangeControl • Documentation • TechnicalWriting • Quality • Engineering • Regulatory • Verification Reach Out to a Recruiter • Recruiter • Email • Phone • Siddhi Kadakia • ***

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