Commissioning Engineer (Associate - Level II)
Commissioning Engineer (Associate - Level II)
Posted today
SENIORITY
Manager
About the role
- Maintains proficiency and understanding of Facilities, Utilities, Systems and equipment operations
- Author and participate to complete commissioning protocols and execution, data analysis and final report preparation for utilities, equipment and instrumentation. This may include site acceptance testing (SAT) and factory acceptance testing (FAT)
- Supports consistent and best practices for creating and executing commissioning protocols
- Ensures accuracy and compliance of commissioning and system records
- Partner with the Validation Department to participate and provide feedback to NN validation process group
- Ability to work and communicate effectively across multiple local departments. multiple international production sites
- Support the creation and review of documentation (Specifications, SOPs, etc.) in accordance with local, NN and regulatory requirements
- Supports Deviations (DV) and Change requests (CR) related to commissioning activities
- Maintain effective communication and ensure alignment in coordination with appropriate teams
- Support facility certification for new or upgraded Pharmaceutical Manufacturing (process equipment and facility-support equipment) and Quality Control facilities as needed and the continued operation of such facilities
- Ensures systems and processes are commissioned in a compliant manner in accordance with FDA, EMA and NN requirements
- Represent Facilities Engineering and actively participate with cross-functional teams (Validation, Manufacturing, Engineering, Facilities and Quality groups) related to commissioning and validation
- Provide data for assessments associated with change control activities
- Review protocols, summary reports and other documentation associated with commissioning
- Serves as Subject Matter Expert (SME) for commissioning activities within Facilities Engineering and point of contact with site Validation Team
- Maintains technical knowledge and current trends within the commissioning process and science and risk-based validation (SRV) programs
- Support commissioning concepts, data and approaches for audits and inspections
- Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes
- Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others
- Other duties as assigned
- Associate's degree in life science or engineering requiredBachelor's degree in life science or engineering preferred
- Work Experience:
- Associate's degree with two (2) years of related experience requiredBachelor's degree with one (1) year related experience preferred
- Pharmaceutical process or biotechnology experience preferred
- Experience with data analysis and report writing
- Entry level understanding of: Concepts of Validation and commissioning
- Change control processes
- Root cause analysis techniques and cGMP documentation practices preferred, not required can be learned on the jobcGMP regulations preferred
- Excellent written and verbal communication skills a must
- A strong work ethic (self-motivated) and demonstrated ability to work in teams as well as independently
Before you apply
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Your notice period
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