Engineer – GMP Physical Test Method Development & Validation (Combination Products) - (JP16052)

3key Consulting, Inc.; Thousand Oaks (CA); Hybrid; USD 58,000 - 63,000; Part time

Job summary

3key Consulting, Inc. seeks an Engineer for GMP physical test method development & validation in Thousand Oaks, CA. The contract role involves developing and validating methods for combination products, transferring to manufacturing, and supporting life cycle of testing processes.

The ideal candidate has a BS with 2+ years in engineering, strong SolidWorks skills, solid writing abilities, and statistical analysis experience. Hybrid onsite work in Thousand Oaks is required.

Qualifications

• Bachelor's degree (or higher) with 2+ years engineering experience or equivalent.
• SolidWorks proficiency and experience with statistical analysis.
• Strong technical writing skills and documentation ability.

Responsibilities

• Develop, qualify, and validate GMP physical test methods for combination products.
• Transfer methods to manufacturing and compile documentation for assemblies.
• Lead cross-functional projects ensuring scope, budget, and timelines.
• Coordinate test method development with contractors and internal teams.
• Generate procedures to support new processes and equipment validation.

Skills

SolidWorks

Technical Writing

Statistics

Education

Master's Degree

Bachelor's Degree + 2 years

Associate's degree + 6 years

High school diploma/GED + 8 years

Tools

Minitab

CAD software

Job description

Engineer – GMP Physical Test Method Development & Validation (Combination Products) - (JP16052)

• Thousand Oaks, CA
• Biotech/Pharmaceutical

Job Title: Engineer – GMP Physical Test Method Development & Validation (Combination Products) - (JP16052)

Location: Thousand Oaks, CA. 91320 (hybrid)

Employment Type: Contract

Business Unit: Physical Testing Systems Development

Duration: 1+ year (with likely extensions and/or conversion to permanent)

Posting Date: 09/23/26

Pay Rate: $42 - $46/hour W2 with benefits

Notes: Only qualified candidates need apply. 3 days a week onsite minimum.

3 Key Consulting is hiring an Engineer – GMP Physical Test Method Development & Validation (Combination Products)for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:

Our ideal candidate will have a B.S. and 2 years of experience. Solid works, statistical analysis, and technical writing.

The Engineer, in Physical Methods, is responsible for engineering activities required for the development / qualification / validation and transfer of physical GMP test methods for combination products, devices, primary containers, and secondary packaging components. The Engineer shall have the ability to work on multiple projects at one time that may involve changes or new product, processes, tooling or equipment introduction to improve quality and reliability and reduce cost. Phases of projects include: developing combination product test methods, providing key expert support for qualification, validation, transfer, and life cycle support of methods for manufacturing, new product introduction, training, and production support.

Why is the Position Open?

Planned Project

Top Must Have Skills:

• Solid works Experience
• Technical Writing Skills
• Statistics Experience

Day to Day Responsibilities:

• Develop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and injection devices.
• Work in teams to transfer new combination product test method and assembly requirements to manufacturing, by developing six sigma processes and compiling documentation for manufacturing assembly requirements.
• Develop, qualify, validate, and transfer new equipment, software, systems, and methods.
• Implement projects per Final Product Technologies and company procedures to ensure projects are completed on schedule and within established budget.
• Coordinate test method development and delivery with selected contractors.
• Ensure that qualification parameters are met for product assembly requirements.
• Support development of cost estimates for new processes, gauges and equipment development used in generation of capital request documentation.
• Generate procedures necessary to support department and new process equipment.
• Gather test method requirements that result in equipment that operates safely and considers ergonomic factors in the design.
• Perform other duties as required by the Group Manager.
• Comply with the requirements, responsibilities, and authority as required.
• Maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project goals.
• Networks internally to ensure alignment, commitment to project objectives and timelines as well as to ensure effective execution of projects.
• Networks with manufacturing, quality and regulatory organizations both internal and external to Amgen.
• Drives the cross-functional communication and integration of information to optimize decision making, issue resolution and change management throughout project lifecycle.
• Excellent verbal and written communication skills are utilized to communicate project status and risks associated with integrated timelines to leadership.
• Collaborates with other functional leaders to ensure project success, momentum and commitment.
• Proactively identifies issues and/or risks and develops mitigation options to resolve or elevate efficiently.
• Integrates partner/vendor timelines with Amgen timelines as appropriate.

Basic Qualifications:

• Master's Degree
• OR Bachelor's Degree and 2 years of engineering/scientific experience
• OR Associate's degree and 6 years of engineering/scientific experience
• OR High school diploma/GED and 8 years of engineering/scientific experience.

Preferred Qualifications:

• M.S. in Mechanical Engineer, Chemical or Biomedical Engineering, or Chemistry
• Excellent written and verbal communication skills
• Ability to work in a highly matrixed team environment
• 2 years of experience in the biotechnology/pharmaceutical industry
• 2 years of experience in equipment, method, and mechanical design
• Technical writing experience
• Experience with SolidWorks (or other 3D-CAD software)
• Experience with combination products and regulatory requirements
• Experience utilizing Minitab (or other statistical software packages)

Red Flags:

• No Solid works Experience.
• No Technical Writing Skills.
• No Statistics Experience.
• Large gaps in employment.
• No validation or qualification experience.
• Must be able to manage multiple projects.
• Lacking communication skills.
• Must be willing to be on site in Thousand Oaks when needed.

Interview process:

30 minute Phone Interview with Reporting Manager; 1 Hour In-Person Panel Interview