Cleaning Validation Engineer

Role: Cleaning Validation Engineer

Location: Albany, NY.

Pay Rate: $55-60/hr on W2

Duration: 6+ Months

*Required Qualifications*

• Bachelor's degree in Engineering, Chemistry, Biology, Life Sciences, or a related technical discipline.

• Minimum 5 years of experience supporting Cleaning Validation, CIP development, process validation, or related engineering functions within pharmaceutical or biotechnology manufacturing.

• Demonstrated hands-on experience with TOC swab and rinse sampling techniques.

• Experience executing cleanability studies and degradation studies in a laboratory environment.

• Proven experience supporting on-floor CIP cycle development and troubleshooting activities.

• Strong understanding of Cleaning Validation principles and regulatory expectations within GMP manufacturing environments.

• Experience supporting biologics manufacturing processes.

• Ability to work effectively within a collaborative team environment while contributing independent technical expertise.

• Strong communication and problem-solving skills.

*Preferred Qualifications*

• Experience supporting monoclonal antibody (mAb) manufacturing facilities.

• Familiarity with upstream manufacturing operations including cell culture and harvest processes.

• Experience supporting downstream purification processes including chromatography and tangential flow filtration (TFF).

• Experience implementing and optimizing CIP systems associated with stainless steel process equipment.

• Exposure to electronic systems such as LabWare, Veeva, or comparable quality and laboratory platforms.

• Previous startup, expansion, commissioning, qualification, or facility-scale implementation experience.

*Desired Experience*

*Candidates should possess practical experience supporting:*

• CIP skid implementation and startup activities

• CIP cycle optimization and troubleshooting

• Cleaning validation execution

• Process vessel cleaning strategies

• Biologics manufacturing equipment cleaning

• Cross-functional collaboration with Validation, Engineering, Manufacturing, and Quality teams

*Key Responsibilities*

• Support laboratory-based cleanability and degradation studies used to establish and optimize cleaning processes.

• Perform TOC swab and rinse sampling activities to evaluate cleaning effectiveness.

• Execute cleaning validation and cycle development protocols within GMP manufacturing environments.

• Support development, optimization, and troubleshooting of new CIP cycles for process equipment and vessels.

• Partner closely with Cleaning Validation, Engineering, Manufacturing, and Quality stakeholders during equipment startup and cleaning process implementation.

• Analyze cleaning process data and provide technical recommendations to improve cycle effectiveness and operational efficiency.

• Assist in troubleshooting cleaning performance issues encountered during CIP cycle development and execution.

• Participate in protocol execution activities and provide technical review and feedback on validation and investigation documentation.

• Support implementation of new CIP skids, product vessels, and associated cleaning systems.

• Maintain compliance with GMP requirements, site procedures, and industry best practices.

Benefits: This a contract position does not include employer-provided benefits.

Equal Opportunity Employer:

We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to

race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Background Check:

Background checks may be conducted in accordance with applicable law.

Work Authorization:

Applicants must be authorized to work in the United States