Congenius provides tailored expertise and leadership to global firms, established SME`s and aspiring start-ups in the medical device, IVD and pharmaceutical industry. If you enjoy working with a diverse range of people across a broad range of projects and are passionate about making a positive contribution to the MedTech industry, then joining our dynamic team could be your next rewarding career step.
Your Responsibilities
Serve as a key liaison between production teams and project leadership, ensuring clear communication and alignment.
Perform technical troubleshooting and coordinate effectively across multiple departments.
Drive optimization and continuous improvement within cleanroom operations, environmental controls, and aseptic manufacturing processes (including sterile filtration of medicinal products).
Develop and implement electronic systems for documenting cleanroom interventions (e.g., MES and deviation management systems).
Apply proven expertise in Process FMEAs to identify and mitigate risks.
Provide guidance and consultation to customers and suppliers, exercising indirect leadership where appropriate.
Demonstrate flexibility to work in cleanroom environments and during shutdown periods to minimize disruption to ongoing production.
Your Skills and Experience
Bachelor or Master's degree in Engineering (Mechanical, Electrical, Process, Chemical, or equivalent)
Professional background: +5 years of experience in technical project execution within GMP and regulated environments (pharmaceutical, biotech, medical devices or life sciences)
Solid understanding of cGMP, EU Annex 1, and engineering documentation
Strong experience in budget planning, project timeline planning, and problem solving
Hands on working experience in GMP environment and authoring technical documents
Team player who w