Lead Engineer
3 days ago
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.
Mid-Senior level
Employment typeFull-time
Job functionEngineering, Manufacturing, and Quality Assurance
IndustriesManufacturing and Pharmaceutical Manufacturing
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