Validation Engineer (Autoclave Focus)

Position Summary

We are partnering with a leading pharmaceutical/CDMO organization to support a critical validation initiative following recent regulatory activity. This is a high-visibility, urgent opportunity for a Validation Engineer with strong autoclave experience to make an immediate impact. The role is heavily focused on autoclave qualification and sterilization validation, with opportunities to expand into broader equipment and facility validation efforts as new projects ramp up.

Key Responsibilities

• Execute autoclave qualification and validation activities (IQ/OQ/PQ)
• Develop, review, and execute validation protocols and reports
• Perform cycle development, thermal mapping, and load studies
• Analyze validation data and ensure accurate, compliant documentation
• Support facility and equipment qualification efforts beyond autoclaves
• Collaborate closely with on-site validation leadership and cross-functional teams
• Investigate deviations, implement corrective actions, and support audits/inspections
• Maintain compliance with FDA, cGMP, and applicable industry standards

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field (or equivalent experience)
• 2–3+ years of hands-on autoclave validation experience (required)
• Proven ability to execute validation work independently and efficiently
• Experience in GMP-regulated pharmaceutical or CDMO environments
• Strong understanding of validation principles and regulatory expectations
• Ability to work onsite and collaborate effectively with cross-functional teams

Preferred Qualifications

• Experience with additional equipment validation (e.g., freezers, sterilization systems)
• Engineering background (Chemical Engineering preferred, not required)
• Familiarity with sterilization standards (e.g., ISO 17665)
• Experience in aseptic or cleanroom environments
• Open to diverse technical backgrounds, including military experience

Key Competencies

• Strong execution and problem-solving skills
• Ability to “hit the ground running” in a fast-paced environment
• Excellent technical writing and data analysis capabilities
• High attention to detail and commitment to quality
• Effective communication and ability to escalate issues appropriately

Logistics

• Location: Hunt Valley, MD (onsite required)
• Candidates: Local preferred; travel candidates considered (PA/NJ/VA region)
• Schedule: May require off-shift or weekend work based on project needs
• Interview Process: 1–2 virtual interviews with quick turnaround

Why This Role?

• Immediate start on a priority, high-visibility project with executive attention
• Strong potential for extension as additional validation projects come online
• Opportunity to contribute to a growing validation program within a leading organization
• Hands-on, impactful role in a fast-moving, collaborative environment

Compensation

• Salary Range: $55-$60 / hour, Commensurate to exp.
• Benefits: Medical, Dental, Vision