Engineer/Visual Inspections

Job Title: Engineer/Visual Inspections

Location: Thousand Oaks CA

Duration: 12 Months

Description:

Top 3 Must Have Skill Sets:

1. Experience with Visual Inspections

2. Basic Lab Experience

3. Biosafety Lab Aseptic Technique

4.) Works well in a team, is open to feedback, and is willing to learn new things.

Work Arrangement: Onsite

We are seeking an Engineer to support visual inspection and drug product process development for sterile injectable products. This hands-on role will focus on visual inspection studies, defect-standard and panel development, laboratory experimentation, technical documentation, and automation-related engineering activities.

Key Responsibilities

Develop and maintain visual inspection defect standards and qualification panels.

Design, execute, and document laboratory and drug product characterization studies.

Establish and maintain GMP procedures supporting visual inspection and laboratory operations.

Analyze experimental data and communicate results to cross-functional teams.

Author protocols, reports, technology-transfer documents, and other technical documentation.

Gather user requirements and support engineering assessments for automation system installations.

Perform field evaluations and provide recommendations for existing equipment and systems.

Support clinical and commercial process introductions, technology transfers, investigations, and process improvements.

Collaborate with Process Development, Manufacturing, Engineering, Automation, Quality, Regulatory, and other functions.

Preferred Qualifications

Three or more years of pharmaceutical or biotechnology industry experience

Experience with visual inspection processes

Experience creating defect standards or inspection panels

Experience with biosafety laboratory practices and aseptic technique

Experience with sterile injectable or aseptic fill/finish processes

Laboratory or pilot-plant experience with process equipment

Experience with automation, computer programming, computerized systems, or robotics

Familiarity with cGMP requirements, technical transfer, root-cause analysis, risk assessments, FMEA, and statistical analysis

Strong experimental design, data analysis, technical writing, and cross-functional communication skills

Basic Qualifications

Master’s degree; or

Bachelor’s degree and two years of engineering and/or operations experience; or

Associate’s degree and six years of engineering and/or operations experience; or

High school diploma or GED and eight years of engineering and/or operations experience.

Basic Qualifications

Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience