Facility & Manufacturing Engineer at Quva

Sugar Land, Texas, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Oct, 26

Salary

0.0

Posted On

13 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

MEP Support, Validation Project Plans, IQ/OQ/PQ, SOP Writing, Equipment Specification, Commissioning, Facility Drawing Maintenance, Project Management, Root Cause Analysis, Technical Writing, Cleanroom Design, Instrument Calibration

Industry

Pharmaceutical Manufacturing

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.” California Consumer Privacy Act (CCPA) Notice for Applicants and Employees [https://onequva.com/california-applicant-employee-privacy-notice-quva]

Responsibilities

The Facility & Manufacturing Engineer provides technical expertise for MEP systems and the design, implementation, and qualification of pharmaceutical production equipment. They are responsible for generating validation protocols, maintaining facility drawings, and driving continual process improvement.