Job Title: Biologics Process Leader
About the Role:
We are seeking a highly experienced and skilled Biologics Process Leader to join our team. In this role, you will be responsible for overseeing the lifecycle of process equipment and validation at our site, ensuring that all activities meet global regulatory requirements.
Key Responsibilities:
* Oversee the lifecycle of process equipment and validation
* Ensure compliance with GMP, GDP, and data integrity standards
* Develop and implement strategies for process equipment and validation
* Lead cross-functional teams to deliver projects on time and within budget
* Maintain inspection readiness for process equipment and validation systems
* Provide technical support to Operations teams
* Drive continuous improvement initiatives
Requirements:
To be successful in this role, you will need:
* Proven experience establishing and scaling Process Engineering/Validation functions
* Expertise in process equipment and validation lifecycle management
* Knowledge of biotechnology manufacturing operations and large-scale unit operations
* Familiarity with ASME BPE, ISPE, EHS standards, and Quality Systems
* Degree in Life Sciences, Chemical/Biological Engineering, or related discipline
* 10+ years in c GMP manufacturing or biologics process development, with significant leadership experience
Benefits:
* Bonus
* Life Assurance
* Pension
* VHI
About Us:
We offer a competitive salary and benefits package, as well as opportunities for career growth and development.