Associate Facilities Engineer

Job Title

Job Description Summary

Job Description

Job Description:

KEY ACCOUNTABILITIES

Responsibilities include but are not limited to the following:

• Perform preventive maintenance (PM) and troubleshooting coordinate equipment repairs and other hands-on operational support activities. Drive excellence and regulatory compliance in all facilities operations.
• Drive execution of approved validation protocols mapping studies cleanroom certifications and other operational support activities as required.
• Execute document and report corrective actions for identified nonconformances audit findings and other quality events. Respond to Corrective & Preventive Action (CAPA) assignments from Site Quality.
• Manage the work order and ServiceNow ticket systems to ensure timely completion operational excellence and regulatory compliance of the facility.
• Update facilities documentation to ensure operational excellence and regulatory compliance. Create change orders (CO) as required to ensure accuracy clarity and quality of documentation. Own and maintain Standard Operating Procedures (SOP) User Requirement Specifications (URS) Quality Plans (QP) and others
• Assist with other routine facilities work and special projects as business needs require.

JOB REQUIREMENTS & QUALIFICATIONS

Education:

• Bachelors degree in Life Science Engineering or a closely related discipline.
• At least 2-4 years of work experience in a documentation-heavy regulated industry (including but not limited to: food processing pharmaceuticals medical devices banking semiconductors aircraft maintenance OR OTHER SIMILAR).
• Preferred but not required: Validation Facilities Quality or Medical Device experience

Minimum Requirements:

• Demonstrated basic proficiency working in an industry with strict regulatory oversight. Familiarity with scientific terminology regulatory writing styles and standards & procedures.
• Proficiency and understanding of Design Control Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP).
• Proficiency with Microsoft Office Outlook Teams
• Highly analytical organized and detail-oriented with strong communication skills.
• Proven record of providing excellent internal and external customer service.
• Demonstrated adherence to the highest ethical standards and professionalism.

Physical Requirements:

• Involves work of a general office nature (50-60%) and hands-on facilities support activities (40-50%). Office work consists of operating a computer while sitting or standing. Hands-on work consists of preventive/corrective maintenance and other facilities support activities.
• Must occasionally lift up to 50lb unassisted.
• Regularly required to talk hear and use hands and fingers to write and type.
• Ability to speak clearly so others can understand you.
• Ability to read and understand information and ideas presented orally and in writing.
• Ability to communicate information and ideas in writing and orally so others will understand.
• Regularly required to utilize vision abilities allowing reading of printed material graphics and computer displays.

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