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

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.

Additional responsibilities may include:

• 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.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.