Pharma Facility & Manufacturing Engineer: Quality & Validation

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

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.