Engineer - Physical Methods

BioSpace; Thousand Oaks (CA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Flexible Spending Accounts

Retirement and Savings Plan

Annual Bonus Program

Stock-Based Long-Term Incentives

Paid Time Off

Career Development Opportunities

Flexible Work Models

Job summary

BioSpace is seeking an experienced professional to develop, qualify, validate, transfer, and manage GMP physical test methods and equipment for combination products, devices, and packaging. You will coordinate cross-functional projects, author documentation, support investigations, and train staff on new methods.

The role emphasizes collaboration with manufacturing, quality, and R&D teams to ensure compliant methods and scalable processes, while driving continuous improvement and leveraging

Qualifications

• Master's degree or equivalent in engineering or related field.
• Bachelor's degree plus 2 years of engineering experience or equivalent.
• Associate degree plus six years of relevant experience applicable to role.
• High school diploma or GED plus eight years of relevant experience.

Responsibilities

• Develop, qualify, validate, transfer, and manage GMP physical test methods and equipment for combination products, devices, containers, and packaging.
• Coordinate cross-functional projects and manufacturing transfers, author documentation, support investigations and continuous improvement, and train staff on new methods and equipment.

Skills

Physical Test Method Development

GMP

Method Qualification and Validation

Combination Products

Mechanical Design

Equipment Design

Technical Writing

SolidWorks

Statistical Analysis

Minitab

PLC and HMI Controls

Vision Systems

Six Sigma

Project Management

Cross-Functional Communication

Manufacturing Process Development

Education

Master's degree

Bachelor's degree + 2 years engineering experience

Associate degree + 6 years

High school diploma / GED + 8 years

Job description

Develop, qualify, validate, transfer, and manage the lifecycle of GMP physical test methods and equipment for combination products, devices, containers, and packaging. Coordinate cross-functional projects and manufacturing transfers, author documentation, support investigations and continuous improvement, and train staff on new methods and equipment.

Requirements:

Applicants need a master's degree, a bachelor's degree plus two years of engineering experience, an associate degree plus six years, or a high school diploma/GED plus eight years. Preferred qualifications include an advanced engineering degree, pharmaceutical or biotechnology experience, equipment and mechanical design, technical writing, 3D CAD, statistical software, combination product regulations, and PLC/HMI or vision systems experience.

Key Skills:

• Physical Test Method Development
• GMP
• Method Qualification and Validation
• Combination Products
• Mechanical Design
• Equipment Design
• Technical Writing
• SolidWorks
• Statistical Analysis
• Minitab
• PLC and HMI Controls
• Vision Systems
• Six Sigma
• Project Management
• Cross-Functional Communication
• Manufacturing Process Development

Benefits:

• Health Insurance
• Dental Insurance
• Vision Insurance
• Life Insurance
• Disability Insurance
• Flexible Spending Accounts
• Retirement and Savings Plan
• Annual Bonus Program
• Stock-Based Long-Term Incentives
• Paid Time Off
• Career Development Opportunities
• Flexible Work Models