CIP/SIP & Process Qualification Engineer in Albany

Job DescriptionJob Description

Duration: 6+ Months

Position Overview:

We are seeking an experienced CIP/SIP and Process Qualification Engineer to support validation and qualification activities within a regulated manufacturing environment. The ideal candidate will have strong hands-on expertise in Clean-In-Place (CIP), Steam-In-Place (SIP), autoclave systems, process qualification, and validation activities.

This role requires a candidate with significant experience working with autoclave validation and testing. The successful candidate should be capable of independently developing, executing, and documenting validation protocols while ensuring compliance with applicable quality and regulatory requirements.

Key Responsibilities

• Develop, execute, and maintain validation protocols and reports for CIP, SIP, and autoclave systems.
• Perform and support equipment and process qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Establish, evaluate, and verify equipment and product hold times to ensure product quality and equipment integrity.
• Conduct process validation and qualification activities in accordance with established procedures and regulatory requirements.
• Partner with cross-functional teams, including Quality Assurance, Manufacturing, Engineering, and Operations, to resolve technical issues and support process improvements.
• Provide technical expertise and troubleshooting support related to CIP, SIP, autoclave, and validation processes.
• Ensure validation activities comply with cGMP, FDA, and other applicable regulatory standards.
• Prepare and maintain accurate validation documentation, protocols, reports, and supporting records.
• Support training and provide technical guidance to team members on CIP/SIP and process validation procedures.

Required Qualifications:

• 8+ years of overall relevant engineering or validation experience.
• Significant hands-on experience with CIP and SIP systems.
• Strong expertise in autoclave validation, testing, and qualification; candidates with 6+ years of in-depth autoclave experience are highly .
• Demonstrated experience performing process qualification and validation activities, including IQ, OQ, and PQ.
• Strong understanding of hold-time studies and their impact on equipment and product integrity.
• Knowledge of process validation, cleaning validation, and applicable regulatory requirements.
• Familiarity with cGMP and FDA-regulated manufacturing environments.
• Excellent technical documentation, communication, and problem-solving skills.
• Ability to work independently while effectively collaborating with cross-functional teams in a fast-paced environment.

Education:

Bachelor's degree in Engineering, Chemistry, Microbiology, or a related technical discipline is .

\nCompany Description

Arthur Lawrence is a US-focused management consulting and staffing firm placing talent across IT, finance, light industries, and pharmaceuticals. We work with Fortune 500 clients and operate with a delivery-first mindset backed by a strong internal training culture.

Company DescriptionArthur Lawrence is a US-focused management consulting and staffing firm placing talent across IT, finance, light industries, and pharmaceuticals. We work with Fortune 500 clients and operate with a delivery-first mindset backed by a strong internal training culture.