Senior Engineer Clean Utilities

JOB PURPOSE:
The role is responsible for writing, performance and reporting on validation activities related to biopharmaceutical Facilities, Utilities, Equipment (FUE) and associated systems (e.g. automation). The individual shall be responsible for planning, coordination and driving validation activities from initiation to successful completion. The individual shall act as the primary decision maker for assigned validation responsibilities, including deviation investigations, risk / impact assessment.

MAIN ACCOUNTABILITIES:
1. Preparation and execution of validation protocols involving facilitates equipment, utilities and associated automation.
2. Preparation, review and approval (as required) of SOPs, validation deviations, change control, validation summary reports and associated documentation.
3. Management and co-ordination of validation activities with internal departments, external contractors and suppliers.
4. Prepare and deliver cross functional training in validation methodologies, protocols and related procedures to facilitate validation activities.
5. Primary point of contact for validation related issues arising during validation activities (including protocol execution).

6. Investigation of deviations / non-conformances to determine impact on product quality, validation status and associated compliance requirements.
7. Partners with functional departments to perform deviation root cause analysis and formulate corrective / preventative actions (CAPA).
8. Performance of risk and impact assessments associated with validation activities, deviations and changes

9. Provides support to commissioning activities, including review of commissioning plans, procedures, turnover packages etc. (as required).
10. Performs final review of test data / reports to ensure conformance with established specifications and related standard operating procedures.

11. Provide guidance on validation requirements and expectations to validation engineers and project team.
12. Represent validation as a subject matter expert (SME) in all project phases (including commissioning and qualification execution).
13. Represent the validation program and designated validation activities during inspection by regulatory agencies and Biogen Quality / Regulatory functions.
14. Review of technical documents / reports to ensure that validation activities are consistent with current company, industry, regulatory requirements, and current technology.

*LI-POT4

- 5–8 years experience in a Validation/Quality role in a biopharmaceutical manufacturing environment. Large scale project experience
- Thorough knowledge of biotechnological technologies, processes and clean utilities.
- Demonstrated proficiency in Goo

The role is responsible for writing, performance and reporting on validation activities related to biopharmaceutical Facilities, Utilities, Equipment (FUE) and associated systems (e.g. automation). The individual shall be responsible for planning, coordination and driving validation activities from initiation to successful completion.