Sr. Cleanroom Engineer (Mexicali, B.C.)

This position is located in Mexicali, Baja California. Primary Function of Position:
The senior cleanroom engineer is the ISI subject matter expert for Controlled Environment Room (CER) regulatory standards and compliance, operational procedures, and industry best practices. Manage and continuously improve CER operating procedures and controls and drive implementation across the organization.

Roles & Responsibilities:

• Specify and participate in new CER designs, startup, and validations
• Develop CER specifications and operating procedures as needed for new product, process, or regulatory requirements.
• Review, manage, and approve changes or modifications to CERs, new processes, equipment, and materials.
• Develop, promote, and implement CER operations training programs and initiatives
• Train, coach, and advise colleagues and new hires as needed for problem solving, risk management, and CER best practices
• Specify, review, and approve consumable operating and cleaning supplies
• Challenge, continuously improve, and document CER cleaning methods, frequency, and efficacy
• Document requirements and assist in evaluating new CER service suppliers for capability, infrastructure, and compliance. Ensure CER service suppliers are trained to relevant ISI procedures
• Drive consistent practices across all sites, domestic and international
• Drive, manage and review environmental and product nonconformance issues
• Subject matter expert for cleanroom operations during quality and regulatory audits, such as FDA, MDSAP, and other governments and agencies

Skills, Experience, Education, & Training:

• Candidates must be willing to change residence to Mexicali (Relocation bonus available).
• 5 -10years relevant experience in a medical device or pharmaceutical company.
• Experience in design, build, validations, and troubleshoot of CER.
• Experience in HVAC systems for CER.
• Bilingual English and Spanish, capable of fluent business conversations (English 80% and over)
  
• Bachelor’s degree in Engineering, Microbiology, Quality, or similar
• Demonstrated understanding of medical device QMS and regulatory requirements, including but not limited to FDA CFR 21 820, ISO13485, ISO14644, ISO14698, IEST RPs.
• Demonstrated understanding of engineering change controls, process verification and validation, and production and process controls in a medical device Controlled Environmental Room
• Experience with developing and maintaining Standard Operating Procedures and Work Instructions
• Experience with the startup and validation of new facilities
• Participation in internal /external quality and regulatory compliance audits