Process Development Engineer

Overview

Senior Executive – US TAG at ACL (Pharmaceuticals, Life Sciences and Medical Devices) –

Job Title:

Process Development Engineer

Location:

Thousand Oaks, CA

Duration: 12 Months

• As a member of the process development team, support senior staff to develop and characterize drug product technologies and manufacturing capabilities, and assist in the process validation and technology transfer of multiple Amgen products to the aseptic fill finish manufacturing plants at Amgen Thousand Oaks, which includes various production lines.
• Support senior staff in the planning, execution, and documentation of characterization, process validation and technology transfer projects.
• Assist in the characterization studies to generate technical data packages, organize data and analyze results, and compile concise summaries under supervision of senior staff.
• Interface with various drug product teams to ensure successful technology transfer and completion of associated technical documentation for Amgen products.
• Assist with experimental design, develop and execute protocols, obtain reproducible and reliable results, analyze and document results, and communicate results to cross-functional groups.

• Bachelor’s degree in any scientific or engineering discipline with 1–3 years of professional experience, or Master’s degree with 0–2 years of experience.
• Familiarity with cGxP and experience in drug product / drug substance manufacturing or process development.
• Knowledge of and hands-on experience with various drug product technologies.
• Displays critical thinking, problem solving and independent research skills.
• Ability to learn new techniques, perform multiple tasks, keep accurate records, follow instructions, and comply with company policies.
• Excellent project management skills and ability to escalate relevant issues to project lead and line-management.
• Strong cross-functional team player with good communication skills (oral and written).
• Ability to work independently and as part of a team with internal and external partners.
• Good computer and organizational skills with strong attention to detail.
• Self-motivated with a positive attitude.

• B.S. or M.S. in scientific or engineering discipline with 1–3 years of relevant professional experience or M.S. with 0–2 years of relevant professional experience.
• Familiarity with cGxP and experience in drug product / drug substance manufacturing or process development.
• Knowledge of and hands-on experience with various drug product technologies.
• Demonstrated ability to learn, problem-solve, and work with cross-functional teams.

Fully onsite - Monday - Friday