Sterling Engineering | Validation Engineer | north chicago, il
6 days ago
Validation Engineer – Cleaning
In this role, you will be responsible for developing and executing validation documentation to support various manufacturing systems. This includes hands-on validation and qualification activities for manufacturing equipment, laboratory instruments, facilities, utilities, and critical processes. You will perform cleaning qualification and validation to ensure compliance with regulatory standards and industry best practices. Working alongside cross-functional teams, you will directly contribute to robust and compliant validation strategies, driving operational excellence and continuous improvement within manufacturing operations.
Responsibilities:
· Develop and validate cleaning procedures for manufacturing equipment and systems in compliance with industry standards and regulatory requirements (FDA, GMP).
· Perform cleaning validation studies, including sampling, analysis, and documentation of results.
· Collaborate with cross-functional teams (e.g., Manufacturing, Quality, Engineering) to ensure effective cleaning processes are designed and maintained.
· Create and update cleaning validation protocols, reports, and Standard Operating Procedures (SOPs).
· Identify and implement improvements in cleaning processes to enhance efficiency, consistency, and compliance.
· Ensure compliance with all applicable safety and environmental regulations during cleaning activities.
· Conduct risk assessments and develop corrective actions as necessary.
· Support audits and inspections by regulatory agencies related to cleaning validation.
Qualifications:
· Bachelor’s degree in Engineering, Chemistry, or related field preferred.
· 3-5 years of experience in cleaning validation or cleaning process development within the pharmaceutical manufacturing environment.
· Minimum 3 years of validation experience, specifically authoring and executing protocols
· Strong understanding of cleaning validation protocols
· Excellent analytical, problem-solving, and communication skills.
· Experience with validation protocols, report writing, and laboratory testing methods.
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