Job Title: Cleaning Validation Engineer

Location: Bedford, MA (Onsite)

Type: W2 Contract | Duration: 6 months (Potential for Extension)

Job Description:

Seeking an experienced Cleaning Validation Engineer to lead validation activities in a medical device manufacturing setting. Responsibilities include developing and executing validation protocols (IQ, OQ, PQ, CVP), conducting risk assessments, performing validation for sterilization processes (EtO, gamma, steam), and leading cleaning validation efforts. Collaborate cross-functionally, generate technical reports, and support FDA inspections.

Qualifications:

- 5–10 years of sterile/cleaning validation in medical device/biotech/pharma.

- Strong knowledge of FDA, ISO 13485, 21 CFR Part 820, and GMP regulations.

- Expertise in sterilization methods and cleaning validation (TOC, bioburden).

- Excellent technical writing and cross-functional collaboration skills.

- Experience with Kaye Validator or similar software is a plus.

Preferred: Experience with QMS tools (e.g., MasterControl) and combination product regulations.