Cleaning Validation & Commissioning Specialist

Job Title: Cleaning Validation & Commissioning Specialist

Location: North Chicago, IL

Hire Type: Onsite, Contract-to-Hire (6-month target conversion)

Target Pay Rate: $60.00/hour (W2, with full benefits package)

Overview:

Sterling has helped build careers for thousands of professionals like yourself. Our expert recruiters support you at every step in the process and as a Best of Staffing company, Sterling provides exciting work with exceptional employers across the U.S.

As a contract employee of Sterling, you are eligible to receive a Full Employee Benefits Package that includes paid time off, paid holidays, 3 medical plans to choose from, dental & vision plans, 401(k), and an Employee Stock Ownership (ESOP) plan.

Job Summary:

Seeking an experienced Cleaning Validation & Commissioning Specialist to support cleaning validation and commissioning activities within a regulated pharmaceutical manufacturing environment. This role ensures that systems and equipment are properly commissioned and that cleaning processes are qualified in compliance with industry regulations and internal quality standards. The specialist will play a key role in minimizing contamination risks and supporting the production of high-quality, compliant products. The ideal candidate brings a strong background in cleaning validation, equipment commissioning, and risk-based quality approaches within pharmaceutical, biotech, or related life sciences industries.

Job Duties:

Lead the development and execution of Cleaning Validation protocols (IQ/OQ/PQ), reports, and supporting lifecycle documentation.

Partner with project engineers and end-users to develop User Requirements and Functional/Design Specifications for equipment, utilities, and facility systems.

Support commissioning activities including FAT/SAT, troubleshooting, and resolution of technical issues.

Perform risk assessments (e.g., FMEA) to identify critical cleaning parameters, controls, and mitigation strategies.

Review technical documentation, SOPs, and batch records for validation impact and compliance.

Provide guidance on cleaning strategies and ensure compatibility with validated systems and manufacturing processes.

Ensure all validation and commissioning activities meet regulatory standards and internal compliance requirements.

Interface cross-functionally with QA, Engineering, Manufacturing, and Operations to support project timelines and resolution of issues.

May supervise or mentor contract validation resources or junior engineers.

Maintain knowledge of current regulatory expectations and industry best practices in cleaning validation and commissioning.

Qualifications:

Bachelorâ s Degree in Engineering, Life Sciences, or a related technical discipline; advanced degree or equivalent experience preferred.

Minimum 6 years of experience in validation, engineering, or quality within pharmaceutical, biotech, or similar regulated industries.

Proven experience in cleaning validation, including method development, verification, and execution.

Hands-on experience with commissioning activities for equipment, utilities, and systems in a GMP environment.

Strong understanding of cGMP, FDA, EMA, ICH guidelines, and risk-based validation principles.

Effective communicator with strong documentation, project coordination, and troubleshooting skills.

Experience managing or supporting multiple concurrent projects in fast-paced environments.

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identify, national origin, disability, protected veteran status, or genetic information.