Facility & Manufacturing Engineer

RXinsider LTD.; Sugar Land (TX); On-site; USD 75,000 - 105,000; Full time

Benefits offered by this job

Comprehensive health benefits

401(k) with company match

Paid time off

Job summary

Quva seeks a Facility/Manufacturing Engineer to ensure quality and safety in pharmaceutical production. You will support MEP design, build, and implementation for new facility projects and production equipment, and you will produce SOPs and validation protocols to ensure compliant operations.

You will collaborate in cross-functional teams, apply analytical problem-solving, and help drive continuous improvement in a regulated manufacturing environment in the United States.

Qualifications

• Bachelor of Science in Mechanical Engineering or equivalent with 2+ years in manufacturing, or associated degree with 5+ years experience.
• Able to pass drug and background checks.
• Experience with large-scale MEP systems; calibration principals; cleanroom design/maintenance.

Responsibilities

• Provide technical skills to support operations and ensure mechanical elements meet requirements.
• Prepare and execute Validation Project Plans and IQ/OQ/PQ protocols and SOPs for pharmaceutical manufacturing.
• Develop specifications for production equipment from aseptic processing to packaging.
• Support design, commissioning, and qualification of production equipment.
• Maintain site drawings and revise as needed.
• Contribute to site/department metrics and continuous process improvement.

Skills

Team player

Technical writing

Verbal/written communication

Project management

Root cause analysis

Analytical thinking

Education

B.S. Mechanical Engineering

2+ years manufacturing

Tools

MS Project

Visio

AutoCAD

SolidWorks

Job description

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.

What The Facility/Manufacturing Engineer Does Each Day

• 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

Our Most Successful Facility/Manufacturing Engineers

• 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

Minimum Requirements For This Role

• 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

Any Of The Following Will Give You An Edge

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

Benefits Of Working At Quva

• 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 Quva

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. Quva’s overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care.

Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quva's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with Quva is “at will.”

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