Facility & Manufacturing Engineer

TX - Sugar Land 1075
1075 W Park One Dr #100
Sugar Land, TX 77478, USA

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.

• 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

• Are team players
• Have strong technical writing skills and verbal/written communication skills, including presentation skills
• Utilize analytical, critical thinking and structured root cause analysis techniques for problem solving
• Demonstrate expertise in project management
• Creatively meet challenges and develop innovative approaches

• 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
• 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

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

• 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

Quva provides industry-leading health-system pharmacy services and solutions, including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of pharmacy.

Quva Pharma’s multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva Bright Stream partners with health systems to aggregate, normalize, and analyze large amounts of complex data…