Process Development Engineer - Sterile Injectable : 26-03093

Akraya, Inc.; Thousand Oaks (CA); On-site; USD 52,000 - 59,000; Full time

Job summary

Akraya, Inc. in Thousand Oaks, CA is seeking a scientist to develop and refine visual inspection processes for sterile injectable drugs.

You will perform hands-on laboratory work to support drug product characterization and prepare essential documentation for process validation, while aligning with GMP standards. The role involves collaborating with cross-functional teams, contributing to automation initiatives, and ensuring rigorous quality and regulatory compliance through accurate data

Qualifications

• Experience with visual inspection processes.
• Proficiency in aseptic technique and lab practices.
• Ability to author technical documentation.
• Experience in pharmaceutical or biotechnology environments handling sterile injectables.

Responsibilities

• Develop and manage visual inspection defect standards and qualification panels.
• Design, execute, and document laboratory and drug product characterization studies.
• Establish and maintain GMP procedures for visual inspection and laboratory operations.
• Analyze experimental data and communicate findings to cross-functional teams.
• Create protocols, reports, and technology transfer documentation.

Skills

Visual Inspection

Biosafety Lab Aseptic Technique

Technical Documentation

GMP Procedures

Data Analysis

Drug Product Characterization

Automation

Sterile Injectable Products

Job description

Primary Skills: Visual Inspection (advanced), Biosafety Lab Aseptic Technique (advanced), Technical Documentation (advanced), GMP Procedures (intermediate), Data Analysis (intermediate), Drug Product Characterization (intermediate), Automation (intermediate), Sterile Injectable Products (intermediate) Contract Type: W2 Contract Duration: 12+ Months Location: Thousand Oaks, CA (Onsite) Pay Range: $38.00 - $43.00 Per Hour

Job Summary: This role focuses on developing and refining visual inspection processes for sterile injectable drugs. You will conduct hands-on laboratory work to support drug product characterization and create essential documentation for process validation. The position also involves contributing to automation initiatives and ensuring adherence to regulatory standards.

Key Responsibilities

• Develop and manage visual inspection defect standards and qualification panels.


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


• Establish and maintain GMP procedures for visual inspection and laboratory operations.


• Analyze experimental data and communicate findings to cross-functional teams.


• Create protocols, reports, and technology transfer documentation.

Must-Have Skills

• Experience with visual inspection processes.


• Proficiency in laboratory practices and aseptic technique.


• Ability to author technical documentation.


• This role requires experience in the pharmaceutical or biotechnology industry, with a focus on sterile injectable products and visual inspection processes.