The Chemgineering Group is a global consulting and engineering company with branches in Switzerland, Germany, Austria, Spain, Mexico, Poland and Serbia. As specialists for efficient processes, we design and implement demanding projects for various industries in the fields of pharmaceuticals, biotechnology, fine chemicals, medical technology, cosmetics, vitamins, diagnostics and food.
We are seeking a highly motivated Qualification Engineer / Qualification Specialist to join our team. This position involves ensuring the compliance and validation activities within whole life-cycle of systems (from design stage to handover to the user) maintaining high standards, and supporting regulatory requirements in the pharmaceutical and biopharmaceutical industries.
Your Tasks
- Creation of higher-level and system-specific qualification and validation documents.
- Develop or review, execute, and maintain qualification protocols and reports (DQ/IQ/OQ/PQ and CSV) for critical facilities, equipment and systems, ensuring compliance with industry regulations and standards (FDA, EMA, ISO).
- Coordination and close cooperation with Client on qualification activities for new facilities, equipment and systems (interface between specialist engineers, customers and suppliers).
- Preparation and implementation of risk assessments to ensure the reliability, safety, and performance of facilities, equipment and systems.
- Provide technical support for troubleshooting and resolution of issues related to critical facilities, equipment and systems. Professional experience in Deviation and Change management.
- Advising our customers on GMP technical issues.
- Maintain and update qualification documentation in line with GMP (Good Manufacturing Practices) and other regulatory requirements.
- Work closely with all stakeholders (internal and external) to ensure seamless project execution and successful validation activities.
- Collaboration on project-specific offers and cost estimates
- Support in professional training in the area of qualification and validation
- Contribute to the training of employees at junior level
Your Profile
- Bachelor's or Master’s degree in Mechanical, Electrical or Process Engineering, Life Sciences, Biotechnology, or a related field.
- Professional experience (>= 3 years) in the biopharmaceutical/pharmaceutical/medical technology industry with very good knowledge in the field of qualification/validation. Hand-on experience is a plus.
- Solid understanding of validation life-cycle and deliverables (i.e. DQ/IQ/OQ/PQ), GMP, and industry regulations.
- Strong knowledge of risk management principles and compliance standards (e.g., FDA, EMA).
- Solid problem-solving skills, attention to detail, and the ability to work in both independently or in a team-oriented environment.
- Assertiveness and independent and structured working methods.
- Professional proficiency of English (spoken and written), while not mandatory proficiency of German is destined advantage and will be taken into serious consideration.
Desired Skills:
- Experience in green-field projects, qualification of systems and equipment in production of mAbs (monoclonal antibodies).
- Hands-on qualification experience of facilities, equipment and systems within biotechnology production facilities, aseptic processing facilities as well as solid forms.
- Experience in international green-field or brown-field projects in main contractor role.
Languages:
- Fluency in German language is desirable
- Good knowledge of English language.
- Russian / French language knowledge is surplus.
What we can offer you:
- Being part of an international company with a secure and stabile background
- Involvement in our technical and language training program
- Working with latest technologies, great possibilities for professional development
- Worldwide allocation of our projects, meeting various cultures, working in different environments, possibilities to personal upgrade
- 23 days of vacation
- Great working atmosphere in a dynamic team
Work environment:
- Primarily office-based with occasional visits to construction sites.
- Full-time position with standard office hours, with flexibility for occasional extended hours based on project needs.
Interested? You recognize yourself in the profile and want to become part of a highly motivated team? Apply for the job just now!
Send us your detailed application, stating your salary expectations and your earliest possible starting date, electronically.
Apply now!
Chemgineering International d.o.o.| Ms. Danica Jelicic | www.chemgineering.com
Apply now!
With our international teams, we carry out demanding consulting and planning projects and develop innovative solutions for well-known customers from the life sciences. Whether for innovative cancer therapies or in the complex regulations of the chemical, pharmaceutical and biotechnological industry - in this environment we offer you many career opportunities and excellent conditions for long-term development.
A family-friendly company with short lines of communication, a lot of creative freedom and a family corporate culture are waiting for you!
Apply now!