Manufacturing Technician, Aseptic Operations & CAPA
Overview
You will own manufacturing readiness and product transfers for a 10-month contract at Hillsboro, OR, supporting a regulated production environment. You will drive process improvements, manage deviations, and lead Root Cause Analysis investigations. You will collaborate with Manufacturing, Quality, and Engineering teams to implement technical changes and ensure compliance. This role stands out for its focus on structured problem-solving and compliance activities in a biologics context.
What You'll Do8
- 1Support manufacturing readiness, product transfers, and new equipment start-up for aseptic operations.
- 2Drive process improvements targeting quality, capability, and reliability in cGMP environments.
- 3Troubleshoot process issues and provide technical support to manufacturing operations.
- 4Manage CAPAs, deviations, and corrective actions to maintain compliance.
- 5Lead Root Cause Analysis investigations using structured problem-solving techniques.
- 6Review and update manufacturing documentation, quality records, and training materials.
- 7Collaborate with cross-functional teams to implement technical changes and validate processes.
- 8Support engineering runs and process design for new products or equipment.
Requirements7
- 1Bachelor's degree in Life Sciences, Physical Sciences, or Engineering.
- 23+ years in manufacturing or process engineering within regulated environments.
- 3Experience with aseptic processing and cGMP quality systems.
- 4Track record of managing CAPAs, deviations, and corrective actions.
- 5Proficiency in Root Cause Analysis tools like 5 Whys or Fishbone.
- 6Ability to write technical documentation for validation and change control.
- 7Strong communication skills for cross-functional collaboration.
Salary Insight
$62 - $64k per year
Location
Required Skills
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