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Process Engineer II/Senior Engineer, Packaging/Visual Inspection

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Genentech

19d ago

  • Job
    Full-time
    Mid & Senior Level
  • Engineering
  • $65K - $175K
  • Hillsboro

AI generated summary

  • You have a Bachelor's in Engineering or related field, 4-11 years bio/pharmaceutical experience, strong knowledge of cGMP regulations, troubleshoot and improve processes, visual inspection & packaging expertise, data analysis skills, detail-oriented, and strong communication skills.
  • You will provide technical support for Inspection and Packaging operations, troubleshoot issues, optimize processes, conduct investigations, implement corrective actions, support validation activities, and stay current on industry advancements.

Requirements

  • You have a Bachelor's degree in Engineering, Pharmaceutical Sciences, or a related technical field.
  • You have significant relevant bio/pharmaceutical experience preferably in aseptic manufacturing operations. (Engineer II = 4-7 years, Senior Engineer = 8-11 years)
  • You have strong knowledge of cGMP regulations and quality systems, with experience working in a regulated environment.
  • You have a proven ability to troubleshoot equipment issues and implement process improvements.
  • You have significant experience with visual inspection systems, including automated, semi-automated, and manual, and packaging processes in a cGMP environment
  • You are proficient in data analysis and statistical tools for process monitoring and optimization.
  • You are detail-oriented with strong analytical and problem-solving skills, with the ability to identify root causes and implement effective corrective actions.
  • You have strong communication and interpersonal skills, with the ability to collaborate effectively in a cross-functional team environment.
  • ​Preferred:
  • Experience with qualification and validation protocols is preferred.
  • Familiarity with Lean Six Sigma principles and continuous improvement methodologies

Responsibilities

  • You will provide technical expertise and support for Inspection and Packaging operations, including process troubleshooting, optimization, and improvement initiatives.
  • You will provide technical support and expertise for drug product manual visual inspection, semi-automated Inspection, automated inspection operations, and packaging operations.
  • You will perform data gathering, root cause analysis, and performance trending to develop appropriate process control changes for complex issues.
  • You will perform product complaint assessments and or investigations, and other related post-market surveillance activities.
  • You will conduct process investigations and root cause analyses to identify and address deviations, non-conformances, and other process-related issues, implementing corrective and preventive actions as necessary.
  • You will utilize Lean Production System elements and methods to continuously improve Engineering tactical business processes and procedures.
  • You will participate in process validation activities, including protocol development, execution, and report writing.
  • You will support equipment qualification and commissioning activities for new manufacturing equipment or processes.
  • You will participate in technology transfer activities from development to commercial manufacturing, ensuring successful scale-up and process validation.
  • You will support regulatory inspections and audits by providing technical expertise and documentation.
  • You will foster an environment that encourages continuous learning. Maintain expertise as necessary to stay abreast of technical and industry advancements, and best practices related to aseptic processing.

FAQs

What is the main focus of this position?

The main focus of this position is to provide day-to-day operations support for the Aseptic Filling Operations, specifically the Visual Inspection and Packaging Processes.

What kind of experience is required for this position?

The ideal candidate should have relevant bio/pharmaceutical experience in aseptic manufacturing operations, with a Bachelor's degree in Engineering, Pharmaceutical Sciences, or a related technical field.

What are some of the responsibilities of this role?

Responsibilities include providing technical expertise and support for Inspection and Packaging operations, troubleshooting process issues, conducting root cause analysis, participating in process validation activities, and supporting regulatory inspections.

What skills are necessary for this role?

Skills needed include strong knowledge of cGMP regulations and quality systems, experience with visual inspection systems and packaging processes in a cGMP environment, proficiency in data analysis and statistical tools, detail-oriented with strong analytical and problem-solving skills, and effective communication and collaboration abilities.

Are there any preferred qualifications for this position?

Preferred qualifications include experience with qualification and validation protocols, familiarity with Lean Six Sigma principles and continuous improvement methodologies.

Science & Healthcare
Industry
10,001+
Employees
1976
Founded Year

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