Stellenbeschreibung:

Qualification Engineers - Frankfurt - German speaking

KPC International - Excellence from Concept to Completion


Key Responsibilities


• Developing and executing qualification plans: Creating detailed plans for validating equipment, systems, and processes.
• Writing and executing protocols: Drafting and carrying out validation protocols (e.g., FAT, SAT, IOQ, PQ).
• Data analysis and reporting: Analysing test data, identifying trends, and preparing comprehensive reports.
• Documentation management: Maintaining accurate and up-to-date validation documentation.
• Troubleshooting and problem-solving: Identifying and resolving issues related to validation and process performance.
• Collaboration: Working with cross-functional teams (e.g., engineering, quality assurance, production).
• Compliance: Ensuring all validation activities adhere to relevant regulatory guidelines (e.g., cGMP, FDA, EMA).
• Change control: Assessing the impact of changes on the validated state of equipment and processes.
• Audit support: Participating in internal and external audits and inspections.



Qualifications


• Education: A bachelor’s or master’s degree in a relevant field (e.g., engineering, science, pharmacy).
• Experience: Typically, 1-5 years of experience in pharmaceutical manufacturing and validation.
• Knowledge: Strong understanding of GMP, GAMP, and other relevant regulatory requirements.
• Skills: Excellent communication, problem-solving, and analytical skills.
• Technical Skills: Proficiency with validation software, equipment, and processes.
• Knowledge of CIP skids, distribution skids, purified water vessels and utilities
• Provide technical support to various team members during execution of qualification protocols.
• Year of experience required: 5-7 experience qualification experience
• German language skills: Intermediate to advanced with the ability to read technical documents



KPC -International offers an inclusive environment where you can broaden your experience, perspective and skills to help make an impact on the lives of others. KPC – International is an Equal Opportunity Employer.

NOTE / HINWEIS:

EN: Please refer to Fuchsjobs for the source of your application

DE: Bitte erwähne Fuchsjobs, als Quelle Deiner Bewerbung