Validation Engineer

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Job description

Responsible to support Chemence Medical Inc (CMI) business. The activities include developing DQ/IQ/OQ/PQ protocols and coordinating and performing equipment qualifications, ensuring that automated process equipment that mass produce medical device consumables and other products, are designed, developed or changed in compliance with specifications, requirements, safety and Company and regulatory guidelines. The Validation Engineer will work closely with Senior validation staff, maintenance, operations, and R&D teams to create and document procedures to validate products and processes, which may include elements of verification and sub-system tests as well as other validation efforts.

Key Duties and Responsibilities:

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

• Assists in authoring validation/qualification protocols, including Design Qualification/Installation Qualification/Operational Qualification/Performance Qualification (DQ/IQ/OQ/PQ).
• Execute validation/qualification protocols for processes, equipment, facilities, and utility systems.
• Prepare validation/qualification summary reports for the executed protocols.
• Support continuous improvement and CAPA (corrective action/preventive action) activities related to validation.
• Contribute to the generation and review of required documentation (SOP's, Protocols, Change Requests/Change Controls) to support validation activities.
• Monitor ongoing design efforts to determine and communicate validation tests, protocols and standards. Propose design solutions that enable and facilitate validation efforts. Serve as quality systems expert on cross functional teams during new equipment design phase. Define test plans during the product development process so that the validation test plans are known in advance.
• Ensure protocols, records, and procedures are in compliance with current Good Manufacturing Practices (cGMP), industry standards and approved SOPs.
• Other duties as assigned.

Qualifications, Education and/or Experience Required:

• Bachelor's Degree in Science/Engineering or related Life Science
• Ability to quickly learn new technologies and applications as necessary to understand validation requirements.
• Prior work experience in FDA regulated environment preferred.
• Working knowledge of quality tools helpful, including statistical techniques, technical writing, metrology and calibration, inspection and testing, Statistical Process Control (SPC), Failure Mode and Effects Analysis (FMEA), sampling principles and Acceptable Quality Level (AQL), process mapping, risk analysis, cause and effect diagrams and Pareto analysis.
• Excellent problem solving (Six Sigma), root cause analysis, and process improvement skills with automated manufacturing and process control equipment.
• Highly proficient in Windows MS Office (Excel, Word, Outlook, PowerPoint, Teams) applications.

Language Skills:

• English required, bilingual (Spanish) a plus.

Physical Demands:

• Must be able to stand for long periods of time, along with frequent bending.
• Manual dexterity sufficient to reach/handle items, work with fingers.
• Ability to lift and push up to 20 pounds.
• Ability to kneel and bend.

Work Environment:

• Non-temperature-controlled warehouse, Non-temperature-controlled production floor, temperature-controlled office.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

AAP/EEO Statement

CHEMENCE® provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.