NPI Operations Specialist
3 weeks ago
Come join Cpl and our partners at Pfizer for an exciting opportunity as a NPI Operations Specialist
- Department: Drug Substance Proteins
- Position Reports to: NPI Operations Manager
The NPI Operations Specialist role involves providing operational and system support for the ongoing NPI requirements of the Drug Substance Operating Unit.
This position focuses on tasks like detailed design/process mapping, risk assessment, training, and project management to support the manufacture of NPI related batches.
Responsibilities of the role include:
- Participating in Operational Readiness Activities and troubleshooting technical issues
- Creating SOPs, batch records, and assessments right the first time
- Training colleagues on new processes and equipment
- Managing investigations and change controls related to NPI
- Reviewing/approving sample plans and managing samples during NPI campaigns
- Providing expertise to ensure safe and efficient facility operation
- Collaborating with various departments and external parties
- Participating in testing activities and risk assessments
- Updating plans and providing input into product integration
Qualifications:
- Education/Experience requirement: Diploma / Bachelors or equivalent experience
- Experience in biopharmaceutical operations and project management
- Familiarity with relevant systems and technical document writing
- Strong communication and problems-solving skills
People/Values:
- Demonstrate Pfizer values and adhere to HR policies
- Engage with stakeholders and actively practice recognition
- Share and seek best practices for personal and team development
- Communicate effectively within different functional groups
- Strong time management and problem-solving abilities
Working Patterns and Duration:
Day-based Monday to Friday with on-call support during NPI studies/batches.
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