Leads the validation efforts associated with the operation of all GMP manufacturing systems (Process Automation System, Manufacturing Execution System) in a highly automated biologics manufacturing facility.
2. Manage test protocol generation, execution, issue resolution and summary report approval of required configuration changes to the site Process Automation System (Delta V).
3. Manage test protocol generation, execution, issue resolution and summary report approval of required configuration changes to the site Manufacturing Execution System (Syncade).
4. Executes and/or leads validation work arising from change controls, capital projects, shutdown/changeover activity, and ongoing revalidation programs.
5. Develops appropriate validation methodologies in collaboration with Operations management and Quality Assurance for novel projects.
6. Leads a portfolio of validation projects under strict deadlines to ensure stakeholder success and bulk drug supply.
7. Executes and/or leads multiple projects and technical work assignments as a point of contact for project stakeholders.
8. Provides validation subject matter expertise (SME), to multi-function teams, advises operations on validation matters, and defends their work before regulatory agencies.
9. Ensures alignment with BMS directives and industry guidelines on validation.
10. Duties may include internal compliance or efficiency improvement efforts within department.
• Specific technical skills with biopharmaceutical processing including a minimum of 6 years of experience developing and/or testing process automation system software (preferably Delta V batch). Understanding of S88 and batch processing operations required. Practical experience with large scale distributed control systems required.
• Knowledge of engineering and science generally attained through studies resulting in a B.S., in engineering (chemical preferred), a related discipline, or its equivalent.
• Relevant experience in a Validation role in the biopharmaceutical industry or its equivalent.
• Mastery of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the know how to work and manage within a regulatory environment.
• Comprehensive DCS and PLC based experience, preferably gained in the pharmaceutical industry.
• Knowledge of procedural batch processing automation in a Delta V environment.
• Knowledge of a system life cycle validation techniques for automation software specification and development.
• Familiar with construction techniques and automation system hardware installation practices.
• Experience with dealing with recognized large automation providers (Emerson, Rockwell preferred).