CIP/SIP and Process Qualification Engineer

Location: Albany, NY

Job Description

We are seeking a detail-oriented and experienced CIP/SIP and Process Validation Engineer to join our team in NY. The ideal candidate will have a strong background in Clean-In-Place (CIP), Steam-In-Place (SIP)/autoclave processes, hold times, and process validation within a regulated manufacturing environment.

Key Responsibilities

• Develop, execute, and maintain CIP and SIP/autoclave validation protocols and reports.
• Establish and verify hold times for equipment and product to ensure compliance with quality standards.
• Perform qualification and process validation activities, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
• Collaborate with cross-functional teams including Quality Assurance, Manufacturing, and Engineering to support process improvements and troubleshooting.
• Ensure all validation activities comply with cGMP, FDA, and other regulatory requirements.
• Maintain detailed documentation and validation records in accordance with company and regulatory standards.
• Provide training and support related to Autoclave / CIP / SIP Process Qualification procedures.

Required Skills and Qualifications

• Proven experience with SIP/autoclave processes and CIP systems.
• Strong understanding of hold times and their impact on product and equipment integrity.
• Hands-on experience in Process Qualification
• Knowledge of regulatory requirements related to process qualification and CQV
• Excellent documentation and communication skills.
• Ability to work independently and as part of a team in a fast-paced environment.

Education

Bachelor’s degree in Engineering, Chemistry, Microbiology, or sufficient years of applicable experience