Senior Validation Engineer

Invent Staffing; North Carolina; On-site; USD 70,000 - 75,000; Full time

Job summary

A leading company in pharmaceutical manufacturing is seeking a Validation Engineer to spearhead Cleaning Validation efforts. In this role, you will execute protocols and ensure regulatory compliance while collaborating across teams. Ideal candidates will have 3-5 years of experience and know the Kneat software. The role involves working in a fast-paced, Greenfield project environment and requires strong technical writing and problem-solving skills.

Qualifications

• 3–5 years direct experience in Cleaning Validation.
• Fill-finish and aseptic manufacturing experience preferred.
• Strong understanding of regulatory guidelines.

Responsibilities

• Develop and execute Cleaning Validation protocols and reports.
• Maintain compliance with cGMP and regulatory requirements.
• Collaborate with QA, QC, Manufacturing, and Engineering teams.

Skills

Technical writing

Problem-solving

Communication

Understanding of FDA guidelines

Tools

Kneat software

CIP/COP systems

Job description

• Develop and execute Cleaning Validation protocols (CIP/COP), sample plans, and summary reports.
• Support the full Cleaning Validation lifecycle from specification review to final report generation.
• Validate and commission water generation systems, clean steam generation systems, distribution systems, process air/gas systems, and storage tanks.
• Perform field verification, document reviews, and contribute to the preparation of commissioning documentation.
• Collaborate with cross-functional teams including QA, QC, Manufacturing, and Engineering.
• Work with Kneat software for validation documentation and approvals.
• Support sample testing and routine troubleshooting during validation activities.
• Maintain compliance with cGMP, regulatory requirements, and internal standards.
• Work efficiently in a fast-paced, Greenfield project environment.

Preferred Qualifications:

• 3–5 years of direct experience in Cleaning Validation.
• Fill-finish and aseptic manufacturing experience strongly preferred.
• Working knowledge of Kneat, CIP/COP systems.
• Strong understanding of FDA, EMA, and other regulatory guidelines.
• Excellent technical writing, problem-solving, and communication skills.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Industries

  Pharmaceutical Manufacturing

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