Autoclave Validation Engineer

Piper Companies is seeking a Validation Engineer (Autoclave Focus) to support a key project with a pharmaceutical/CDMO partner in Hunt Valley, MD. This role supports a critical validation effort driven by recent regulatory activity. It's a high-priority opportunity for a Validation Engineer with hands-on autoclave expertise to contribute immediately. The primary focus is autoclave qualification and sterilization validation, with potential involvement in broader equipment and facility validation as additional projects are launched.

Role Responsibilities:

Perform autoclave qualification activities (IQ/OQ/PQ) Author, review, and execute validation protocols and reports Conduct cycle development, thermal mapping, and load studies Analyze validation data and ensure accurate, compliant documentation Assist with facility and equipment qualification beyond autoclaves Partner with validation leadership and cross-functional teams onsite Investigate deviations, implement corrective actions, and support audits Ensure compliance with FDA, cGMP, and industry standards

Required Qualifications:

Bachelor's degree in Engineering, Life Sciences, or related field (or equivalent experience) 2-3+ years of direct autoclave validation experience Ability to independently execute validation activities Experience in GMP-regulated pharmaceutical or CDMO environments Solid understanding of validation principles and regulatory requirements Ability to work onsite and collaborate across teams

Preferred Qualifications:

Experience with additional equipment validation (e.g., freezers, sterilization systems) Engineering background (Chemical Engineering a plus) Familiarity with sterilization standards (e.g., ISO 17665) Experience in aseptic or cleanroom environments Open to diverse technical backgrounds, including military experience

Compensation:

Pay Rate:

$55-$60/hour (based on experience)

Comprehensive Benefits:

Medical, Dental, Vision, etc.