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.