Visual Inspection & Drug Product Process Development Engineer – Sterile Injectables (JP15969)

3key Consulting, Inc.; Thousand Oaks (CA); Presencial; USD 85.000 - 96.000; A tiempo parcial

Descripción de la vacante

3key Consulting, Inc. is hiring a Visual Inspection & Drug Product Process Development Engineer - Sterile Injectables for a 1+ year contract in Thousand Oaks, CA.

The role emphasizes hands‑on lab work, GMP support, and cross‑functional collaboration to advance sterile injectable processes. The engineer will design and document studies, develop defect standards and panels, and contribute to automation assessments while interfacing with Process Development, Manufacturing, Engineering, Quality, and

Formación

• Master's degree in engineering or related field.
• Bachelor's degree with 2+ years of engineering/operations experience.
• Associate's degree with 6+ years of engineering/operations experience.
• High school diploma or GED with 8+ years of engineering/operations experience.

Responsabilidades

• Design, execute, and document lab and drug product characterization studies.
• Establish GMP procedures supporting visual inspection and lab operations.
• Analyze data and communicate results to cross‑functional teams.
• Author protocols, reports, tech transfer documents, and other technical documentation.
• Support automation system installations and related engineering assessments.
• 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.

Educación

Master's degree

Bachelor's degree with 2+ years experience

Associate's degree with 6+ years experience

High school diploma or GED with 8+ years experience

Descripción del empleo

Visual Inspection & Drug Product Process Development Engineer - Sterile Injectables (JP15969)

• Thousand Oaks, CA
• Biotech/Pharmaceutical

Job Title: Visual Inspection & Drug Product Process Development Engineer - Sterile Injectables (JP15969)

Location: Thousand Oaks, CA. 91320

Employment Type: Contract

Business Unit: Commercial DP - ATO Site PD

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

Posting Date: 09/8/26

Pay Rate: $41 - $46/hour W2

3 Key Consulting is hiring a Visual Inspection & Drug Product Process Development Engineer - Sterile Injectables (JP15969) for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:

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. Activities include:

• 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.

Why is the Position Open? Supplement additional workload on team

Top Must Have Skills:

• Experience with Visual Inspections
• Basic Lab Experience
• Biosafety Lab Aseptic Technique
• 4.) Works well in a team, is open to feedback, and is willing to learn new things.

Day to Day Responsibilities:

• Supports ongoing hands‑on lab‑based development in visual inspection process development (i.e. development and maintenance of defect standards and panels, establishment of GMP procedures related to operations)
• Implements and documents off‑line and on‑site drug product characterization studies
• Author and/or own high‑quality process technology transfer and other technical documents

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.

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

Red Flags:

• No Lab Experience
• Not good with hands‑on work.

Interview process:

• 1st 30 minutes with team lead
• 2nd 30 minutes with team