Validation Engineer, Sterile & Cleaning

Katalyst CRO; Bedford (MA); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player in pharmaceutical manufacturing is looking for a skilled Validation Engineer specializing in Sterile and Cleaning processes. This role emphasizes the development and execution of validation protocols, ensuring compliance with stringent FDA and ISO regulations. The ideal candidate will possess strong technical writing skills and a solid background in validation methods, working independently while collaborating with cross-functional teams. Join a dynamic environment where your expertise will contribute to the quality and safety of medical devices, making a significant impact in the industry.

Qualifications

• 5-10 years of experience in sterile and cleaning validation.
• Strong technical writing skills for validation protocols and reports.

Responsibilities

• Develop and execute validation protocols in compliance with FDA and GMP regulations.
• Collaborate with R&D, Quality, and Regulatory teams on validation strategies.

Skills

Sterile Validation

Cleaning Validation

Technical Writing

Risk Assessments

GMP Regulations

FDA Regulations

Bioburden Reduction

Tools

Kaye Validator

MasterControl

Job description

Join to apply for the Validation Engineer, Sterile & Cleaning role at Katalyst CRO.

We are seeking an experienced Sterile & Cleaning Validation Engineer to support validation activities within a medical device manufacturing environment. The ideal candidate will have hands-on experience with sterile and cleaning validation processes, strong technical writing skills, and the ability to execute validation protocols independently.

Responsibilities:

1. Develop and execute sterile and cleaning validation protocols (IQ, OQ, PQ, CVP) in compliance with FDA, ISO 13485, and GMP regulations.
2. Perform risk assessments and gap analyses to ensure validation requirements are met.
3. Conduct validation activities for autoclaves, cleanrooms, sterilization cycles (ethylene oxide, gamma, steam), and CIP/SIP systems.
4. Lead cleaning validation efforts, including residue analysis, recovery studies, and acceptance criteria development.
5. Collaborate with R&D, Quality, Manufacturing, and Regulatory teams to ensure validation strategies align with product and process requirements.
6. Generate technical reports, validation master plans (VMPs), and final summary reports.
7. Provide support during FDA inspections and audits related to validation activities.
8. Identify process improvements and troubleshoot validation deviations.

Requirements:

1. 5-10 years of experience in sterile and cleaning validation within a medical device, biotech, or pharmaceutical environment.
2. In-depth knowledge of FDA regulations, ISO 13485, 21 CFR Part 820, EU MDR, and GMP.
3. Strong expertise in sterilization validation methods (EtO, gamma, steam, dry heat).
4. Hands-on experience with cleaning validation, TOC analysis, and bioburden reduction strategies.
5. Excellent technical writing skills for validation protocols and reports.
6. Ability to work independently on the manufacturing floor and collaborate cross-functionally.
7. Experience with Kaye Validator or similar advanced validation software (AVS) is a plus.
8. Experience with MasterControl or other QMS platforms.
9. Prior involvement in equipment validation for laboratory and production environments.
10. Understanding of combination product regulations (if applicable).

Additional Details:

• Seniority level: Mid-Senior level
• Employment type: Contract
• Industry: Pharmaceutical Manufacturing