Lead Engineer

2 days ago


Københavns Kommune, Denmark AM Group Full time
Lead Engineer / Project Manager - SIP (Sterilization in Place)

AM Group Copenhagen Municipality, Capital Region of Denmark, Denmark

Job Summary

We are seeking an SIP Lead Engineer / Project Manager to lead projects focused on Sterilizing In Place (SIP) systems within the pharmaceutical industry. This role requires expertise in clean steam sterilization processes and equipment, with a willingness to work hands-on, conducting tests and validation activities. The ideal candidate has a strong technical background, practical experience in validation, and the ability to manage projects independently while ensuring compliance with cGMP standards.

Responsibilities

  • Manage projects involving SIP systems, including clean steam generation, utilization, and application in pharmaceutical production equipment such as piping, vessels, and instruments.
  • Perform validation activities, including FAT, SAT, IQ, OQ, and PQ, adhering to state-of-the-art GMP standards.
  • Draft and review validation protocols, reports, and approval documentation.
  • Conduct hands-on testing, troubleshooting, and optimization of SIP systems.
  • Oversee the integration and validation of clean steam equipment in compliance with cGMP requirements.
  • Ensure timely project delivery while maintaining high-quality standards.
  • Coordinate project timelines, resources, and deliverables to meet client expectations and regulatory requirements.
  • Monitor project progress and address challenges to ensure successful outcomes.

Qualifications

  • Engineering degree in Mechanical, Chemical, or a related field.
  • Minimum of 6 years of experience working in process engineering.
  • At least 1 year of experience focused on SIP systems, within the pharmaceutical, biotechnology, or related industries.
  • Practical, hands-on experience in validation processes and activities.
  • Strong knowledge of clean steam generation, utilization, and equipment validation.
  • Familiarity with CIP systems is an advantage.
  • Willingness to work on-site and participate directly in validation and testing processes.
  • Fluency in English; additional European languages are an advantage.
  • Strong problem-solving and analytical skills.
  • Excellent communication and collaboration abilities.
Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Engineering, Manufacturing, and Quality Assurance

Industries

Manufacturing and Pharmaceutical Manufacturing

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