Facility & Manufacturing Engineer

Quva • Sugar Land, TX

11d • Onsite

About The Position

Our Facility / Manufacturing Engineer plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include providing MEP support around the design, building and implementation of new facility projects and production equipment. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

Requirements

• Bachelor of Science in Mechanical Engineering or equivalent engineering degree with 2+ years’ experience in a manufacturing environment or Associated degree in Mechanical Engineering or equivalent engineering degree with 5+ years’ experience in a manufacturing environment
• Able to successfully complete a drug and background check
• Equipment/Instrument Calibration Principals
• Direct experience working on large scale MEP systems
• Honeywell EBI BMS
• Cleanroom Design, Operation and Maintenance
• Experience with pharmaceutical grade compressed air systems
• Knowledge with local and state regulatory requirements
• Must be currently authorized to work in the United States on a full-time basis; Quva will not sponsor applicants for work visas

Nice To Haves

• PC literate with a working knowledge of MS Project, Visio, AutoCAD and SolidWorks
• 2 years of experience in a regulated industry

Responsibilities

• Provides technical skills and expertise to support operations and ensure mechanical elements for manufacturing are designed and operating as required
• Generates and executes (as applicable) Validation Project Plans, Validation protocols -Installation Qualifications/Operational Qualifications/Performance Qualifications (IQ/OQ/PQ) and summary reports and Standard Operating Procedures (SOPs) as required for pharmaceutical manufacturing
• Develop and write specifications for production equipment from aseptic processing to labeling and packaging
• Support design of production equipment and responsible for commissioning/qualification
• Maintaining site level facility drawings including revising where required
• Supports development of site and departmental metrics to gauge ongoing performance of organization and identification of opportunities for continual process improvement

Benefits

• Comprehensive health and wellness benefits including medical, dental and vision
• 401k retirement program with company match
• 17 paid days off plus 8 paid holidays per year
• National, industry-leading high growth company with future career advancement opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level