Job description

Requirements and Skills:

• BS degree with 7+ years of experience in Validation, Engineering, Microbiology or Quality.
• Extensive knowledge and demonstrated experience managing Validation activities for Pharmaceutical / Biotechnology projects.
• Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.
• Demonstrated strong Communication and Leadership skills.
• Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.
• Strong understanding of a risk-based approach to commissioning, qualification and validation within the biotechnology industry.
• In-depth understanding and application of validation principles, concepts, practices, and standards.
• In-depth knowledge with cGxP as well as regulatory regulations and compliance requirements for Biologics Drug Product manufacturing.
• Working knowledge of sterilization/decontamination systems and industry practices.
• Experience with AVS (Airflow Visualization) Studies.
• Experience of aseptic processing.
• People management skill

What will you do
Validation lead for a large-scale Fill Finish Project in the Pharmaceutical Industry. Lead a team of Validation engineers to ensure the Validation activities associated with a large fill finish project are completed safely, as per schedule and in compliance with GMP and Quality Requirements.

Responsibilities:

• Coordinates and Supervises all Validation activities.
• Approves Validation planning documents detailing overall strategy for the project.
• Develops and approves the master list of Validation test documents and activities.
• Reviews and Approves all C&Q summary reports and Validation Summary reports.
• Ensures the Validation schedule is developed and maintained.
• Ensures all Validation Engineers who perform Validation activities have relevant training assigned.
• Pre-Approval and Post approval of Validation test documents.
• Manages Validation coordination meetings.
• Responsible for Overall Tracking and Reporting of Validation status and risks/issues.
• Assist in the development of User Requirement Specifications (URS’s) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).

Requirements and Skills:

• BS degree with 7+ years of experience in Validation, Engineering, Microbiology or Quality.
• Extensive knowledge and demonstrated experience managing Validation activities for Pharmaceutical / Biotechnology projects.
• Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.
• Demonstrated strong Communication and Leadership skills.
• Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.
• Strong understanding of a risk-based approach to commissioning, qualification and validation within the biotechnology industry.
• In-depth understanding and application of validation principles, concepts, practices, and standards.
• In-depth knowledge with cGxP as well as regulatory regulations and compliance requirements for Biologics Drug Product manufacturing.
• Working knowledge of sterilization/decontamination systems and industry practices.
• Experience with AVS (Airflow Visualization) Studies.
• Experience of aseptic processing.
• People management skills

If you would like to have a confidential conversation regarding this opportunity please reach out to Tim Browaeys, tim.browaeys@orioneng.com or contact Tim on 0044 7593448607

opportunity #multinational #pharmaceutical #biotechnology #validation #lead

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment