Key Responsibilities
Project Scope & Strategy Development
* Establish the technical specifications and success criteria for projects, ensuring they align with GMP standards, operational objectives, and compliance requirements
* Collaborate with stakeholders to incorporate operational enhancements into the project plan
* Create a detailed roadmap for the project lifecycle, from initial design through performance qualification
Technical Leadership
* Serve as the primary technical representative for projects, ensuring mechanical modifications and operational enhancements adhere to required specifications
* Coordinate with EPCM teams to align engineering deliverables with technical and operational needs
* Offer guidance and support to production personnel in implementing operational improvements
Quality and Compliance Oversight
* Ensure that all project activities adhere to GMP regulations and internal quality standards
* Work with QA teams to manage GMP change control processes, including the preparation, review, and approval of Technical Change Requests (TCRs) and Change Records (CRs)
Cross-Functional Coordination
* Communicate with operations, maintenance, engineering, and quality teams to ensure seamless integration of mechanical modifications into production
* Facilitate communication and alignment between production staff and the EPCM to resolve any technical issues or deviations
Project Execution and Monitoring
* Track the progress of technical and operational activities to guarantee milestones are achieved on schedule and within budget
* Perform risk assessments and develop mitigation strategies for potential project obstacles
* Provide regular updates and technical reports to project stakeholders
Testing and Qualification
* Lead the planning and execution of equipment commissioning, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities
* Oversee and collaborate with validation teams to ensure the effectiveness and reliability of implemented changes