Engineer, Primary Container Testing, Characterization & Qualification - Biopharma/Medical Device - (JP16093)

3 Key Consulting; Thousand Oaks (CA); Hybrid; USD 55,000 - 63,000; Full time

Job summary

3 Key Consulting is seeking an Engineer for Primary Container Testing, Characterization & Qualification in Thousand Oaks, CA. This 18+ month contract role with hybrid onsite requirements sits in Biopharma/Medical Device and offers a $40–$46/hour W2 pay rate with benefits.

The candidate will support the Container Closure Integrity (CCI) team, develop and qualify test methods, analyze data, and prepare technical documentation while collaborating with Process Development, Manufacturing, Quality,

Qualifications

• Bachelor's degree in engineering or related field.
• 0–3 years of relevant industry experience; internship or co-op experience is a plus.
• Strong technical writing and data analysis skills.
• Ability to work independently while supporting multiple projects.

Responsibilities

• Lab testing, data collection, documentation and data analysis, developing a test method for new/existing instrument.
• Support development, qualification, and lifecycle management of test methods.
• Generate and review technical documents including protocols and reports.
• Collaborate with cross-functional teams and maintain GMP/data integrity.

Skills

Engineering background

Data analysis

Technical writing

Independent work

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Excel

JMP

Minitab

Python

Job description

Engineer, Primary Container Testing, Characterization & Qualification - Biopharma/Medical Device - (JP16093)

• Thousand Oaks, CA
• Biotech/Pharmaceutical

Job Title: Engineer, Primary Container Testing, Characterization & Qualification - Biopharma/Medical Device - (JP16093)

Location: Thousand Oaks, CA. 91320 (hybrid)

Employment Type: Contract

Business Unit: Physical Sciences and Engineering

Duration: 18+ months with likely extensions and/or conversion to permanent

Posting Date: 11/4/2026

Target start date: 12/7/2026

Pay Rate: $40 - $46/hour W2 with benefits

Notes: Hybrid: 2x a week onsite

3 Key Consulting is hiring an Engineer with exposure to container closure integrity (CCI), sterile product manufacturing, pharmaceutical packaging, or analytical test methods, for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:

The Contract Engineer will support the Container Closure Integrity (CCI) team in the initiation, development, qualification, and execution of projects related to package integrity and sterility assurance for pharmaceutical drug products. The position will work closely with senior engineers and scientists to support method development, qualification activities, technical studies, and laboratory investigations utilizing various CCI technologies.

Key responsibilities include assisting in the design and execution of experimental studies, collecting and analyzing data, authoring technical documentation, supporting test method development and optimization, and translating project requirements into executable protocols and reports. The engineer will also support equipment evaluations, troubleshooting activities, laboratory automation initiatives, and implementation of new technologies to improve testing efficiency and reliability.

• Supporting development, qualification, and lifecycle management of container closure integrity test methods.
• Assisting with execution of engineering studies, process characterization, and design verification activities.
• Generating and reviewing technical documents including protocols, reports, work instructions, and standard operating procedures.
• Supporting data analysis, trend evaluations, and investigation activities.
• Collaborating with cross-functional teams including Process Development, Manufacturing, Quality, Packaging Engineering, and Analytical Sciences.
• Evaluating existing systems and recommending process improvements or automation opportunities.
• Maintaining compliance with GMP, data integrity, and documentation requirements where applicable.

Basic Qualifications:

• Bachelor's degree in Engineering, Life Sciences, Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or related technical field.
• 0-3 years of relevant industry experience; internship or co-op experience in a pharmaceutical, medical device, biotechnology, or engineering environment is a plus.
• Strong technical writing and data analysis skills.
• Ability to work independently while supporting multiple projects in a collaborative environment.

Preferred Qualifications:

• Exposure to container closure integrity (CCI), sterile product manufacturing, pharmaceutical packaging, or analytical test methods.
• Experience with laboratory equipment, instrumentation, automation systems, robotics, or computer-controlled systems.
• Familiarity with data analysis tools such as Excel, JMP, Minitab, or similar statistical software.
• Basic programming experience (Python, VBA, MATLAB, LabVIEW, or similar) is a plus.
• Strong problem-solving, organizational, and communication skills.

Top Must Have Skills:

• 1 - Engineering or science background
• 2- Solid Understanding of Engineering/science Fundamental
• 3- Good Communication Skills

Day to Day Responsibilities:

Lab testing, data collection, documentation and data analysis, developing a test method for new/existing instrument

Red Flags:

• Candidate has inflexible schedule
• Not able to come onsite
• Not a good team player

Interview process:

One phone call and one technical interview.