Qualification Engineer
- Getiva Solutions LLC
16 Hours Ago
NA
W2, C2C
Albany-NY
13-18 Years
Required Skills: autoclave validation, CIP, SIP
Job Description
Qualification Engineer (CIP/SIP and Process)
Role Overview
We are seeking a detail-oriented and experienced CIP/SIP and Process
Qualification Engineer to join our team in Albany, NY. The ideal candidate will bring a strong technical background in Clean-In-Place (CIP), Steam-In-Place (SIP)/autoclave processes, holdtime studies, and process validation within a cGMP-regulated manufacturing environment.
Key Responsibilities
• Protocol Development & Execution: Draft, execute, and analyze CIP and SIP/autoclave validation protocols and final reports.
• Equipment & Process Qualification: Perform hands-on Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities across manufacturing equipment and systems.
• Hold Time Verification: Establish and verify hold times for equipment and product solutions to ensure strict compliance with quality standards.
• Cross-Functional Support: Partner with Quality Assurance, Manufacturing, and Engineering teams to support continuous process improvements and resolve technical deviations.
• Regulatory Compliance: Maintain full compliance with cGMP, FDA regulations, cleaning validation guidelines, and internal quality standards.
• Documentation & Training: Author detailed validation records and documentation, and provide training on CIP/SIP and process validation procedures to operational personnel.
Required Qualifications & Experience
• Experience: Minimum of 8+ years of hands-on experience in process qualification within a regulated pharmaceutical or biotech manufacturing environment.
• Technical Expertise: Proven track record in CIP systems, SIP/autoclave process validation, and hold-time studies.
• Regulatory Knowledge: Deep understanding of cGMP regulations, FDA guidance, and cleaning/process validation protocols.
• Soft Skills: Excellent technical writing, verbal communication, and cross-team collaboration skills; ability to operate independently in a fast-paced setting.
