Facility & Manufacturing Engineer

About the role

Our Facility / Manufacturing Engineer plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. You will provide 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.

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.
• Develops and writes specifications for production equipment from aseptic processing to labeling and packaging.
• Supports design of production equipment and is responsible for commissioning/qualification.
• Maintains site-level facility drawings, including revising where required.
• Supports development of site and departmental metrics to gauge ongoing performance and identify opportunities for continual process improvement.

Requirements

• Bachelor of Science in Mechanical Engineering or equivalent engineering degree with 2+ years’ experience in a manufacturing environment or Associate 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.
• Experience with Honeywell EBI BMS, cleanroom design, operation and maintenance, and pharmaceutical-grade compressed air systems.
• Knowledge of 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.

Skills

• Strong technical writing and verbal/written communication skills, including presentation skills.
• Analytical, critical thinking, and structured root cause analysis techniques for problem-solving.
• Expertise in project management.
• Creativity in meeting challenges and developing innovative approaches.
• PC literate with a working knowledge of MS Project, Visio, AutoCAD, and SolidWorks (preferred).
• 2 years of experience in a regulated industry (preferred).

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.

About the company

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 BrightStream partners with health systems to aggregate, normalize, and analyze large amounts of complex data across their sites of care, and through proprietary machine learning, transforms data into actionable insights supporting revenue optimization, script capture, inventory management, drug shortage control, and more.