Validation Engineer

Direct message the job poster from KKR Consulting

KKR Consulting partners with businesses to solve challenges, streamline processes, and achieve lasting success. We specialize in providing tailored consulting services across Aerospace, Medical Devices, Automotives, Pharmaceuticals, and Biotechnology industries, helping clients drive innovation, enhance operations, and achieve sustainable growth.

Job Title: Validation Engineer

Location: MA (Onsite)

Job Summary: We are seeking an experienced Validation Engineer to join our team in Boston, MA. The ideal candidate will have a strong background in the pharmaceutical or biotech industry and experience in commissioning, qualification, and validation of equipment, systems, and processes in a regulated (cGMP) environment. This role is onsite and requires hands‑on technical expertise as well as documentation and regulatory compliance capabilities.

• Lead and execute CQV life cycle activities for process equipment, utilities (clean and black), HVAC, and laboratory systems.
• Prepare and review CQV documentation: URS, DQ, FAT, SAT, IQ, OQ, PQ protocols and reports.
• Perform risk assessments (FMEA, GEP-based assessments) and support implementation of mitigation strategies.
• Ensure compliance with FDA, EMA, and ICH regulations and cGMP practices.
• Interface with cross‑functional teams including engineering, QA, manufacturing, and automation.
• Support and troubleshoot deviations, CAPAs, and change controls related to CQV projects.
• Coordinate with contractors, vendors, and third‑party consultants to meet validation project timelines.
• Manage multiple validation projects and ensure successful execution within budget and schedule.

• Bachelor’s degree in Engineering (Mechanical, Chemical, Biomedical, or related field).
• CQV experience in the pharma/biotech industry.
• Strong understanding of validation principles (V-model, ASTM E2500, ISPE Baseline Guides).
• Proven experience with qualification of utilities (WFI, Clean Steam, HVAC), equipment (autoclaves, bioreactors, chromatography skids, etc.), and lab instruments.
• Excellent documentation and technical writing skills.
• Knowledge of regulatory requirements (FDA 21 CFR Part 11, Part 210/211).
• Ability to work independently in a fast‑paced, dynamic environment.

Seniority Level: Mid‑Senior level

Employment Type: Contract

Job Function: Pharmaceutical Manufacturing and Biotechnology Research

• Medical insurance
• Vision insurance
• 401(k)

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