Senior Manufacturing Process Engineer USP

AXEPTA SA
Vaud

3T

My client is a growing biopharmaceutical company based in the French part of Switzerland looking to expand their team in manufacturing.

Due to this growth my client is looking for a Senior Manufacturing Process Engineer USP to be the expert in manufacturing scale equipment and processes.

Senior Manufacturing Process Engineer USP

My client is a growing biopharmaceutical company based in the French part of Switzerland looking to expand their team in manufacturing.

Due to this growth my client is looking for a Senior Manufacturing Process Engineer USP to be the expert in manufacturing scale equipment and processes.

Responsibilities:

  • Support the development and implementation of process validation plans including protocols in cooperation with the Validation/Qualification Group
  • Raise, assess, manages Change Controls and deviations including any corrective actions arising during production
  • Lead PQ activities
  • Author, review, approve, maintain life cycle (…etc.) all required Standard Operating Procedures, Work Instructions, PQ protocols and other quality documents related to areas of responsibility, as well as support other areas as required
  • Act as a mentor to manufacturing team members and lead by example to ensure integration of good engineering practices
  • Proactively propose problem resolution to process and manufacturing equipment
  • Actively participate in process and technology transfer

Your profile:

  • BSc, Master or Engineering Degree in Pharma/Biotech engineering
  • Relevant experience in biotech industry related to cGMP drug manufacturing, process design, equipment qualification, change control, equipment modification, and process validation
  • Direct experience in FMEA, root cause analysis, and associated quality assessment tools
  • Minimum 7-12 years of experience in a similar role
  • Ability to work in a fast paced – high regulated environment
  • French and English (Fluent)
  • Team work oriented mindset
  • Contribute positively to a strong culture of business integrity and ethics
  • Act within compliance and legal requirements as well as within company guidelines