**Job Summary**
We are seeking an accomplished professional to take on the role of Senior Engineer for Process and Cleaning Validation. As a key member of our team, you will be responsible for leading cleaning validation activities in our cGMP manufacture of biological bulk drug substance.
This is a challenging position that requires a high degree of technical expertise, strong leadership skills, and the ability to work collaboratively with cross-functional teams. If you have a passion for ensuring the highest standards of quality and safety in pharmaceutical manufacturing, we encourage you to apply.
Main Responsibilities:
* Cleaning Validation: Develop and implement effective cleaning strategies for CIP and COP systems, ensuring compliance with EudraLex GMP guidelines.
* Project Leadership: Lead cleaning validation projects for media, buffer, upstream, and downstream equipment trains, prioritizing activities based on project schedules.
* Collaboration and Communication: Work closely with colleagues within the Process Engineering and Validation team and cross-functional departments (QA, Manufacturing, Automation, and QC) to ensure seamless execution of cleaning validation activities.
Requirements:
* Technical Competencies: A minimum of 8 years of experience in cleaning validation, with a strong background in troubleshooting cleaning and cleaning validation challenges, and providing solutions for GMP manufacturing.
* Education: BEng or BSc in Chemical/Process Engineering or relevant science discipline, with a postgraduate qualification in an engineering or scientific discipline being advantageous.
* Behavioral Competencies: Strong leadership competencies with demonstrated management skills, good people skills, and the ability to present and successfully defend technical and scientific approaches in both written and verbal form.
Benefits:
* Bonus Scheme: Eligible for bonus payments as part of our performance-based reward system.
* Professional Development: Opportunities for continuing education and professional growth, with educational assistance available.
* Lifestyle Benefits: Comprehensive life assurance, pension scheme, and VHI coverage.
About Us:
We are committed to creating a diverse and inclusive work environment that supports our employees' growth and well-being. We value innovation, teamwork, and a collaborative approach to achieving excellence in pharmaceutical manufacturing.