Your responsibilities
Project Scope and Strategy Development:
* Define the technical requirements and success criteria for the project, ensuring alignment with GMP standards, operational goals, and compliance expectations.
* Collaborate with stakeholders to integrate operational improvements into the overall project plan.
* Develop a comprehensive roadmap for the project lifecycle, from conceptual design through performance qualification (PQ).
Technical Leadership:
* Act as the primary technical point of contact for the project, ensuring all mechanical adaptations and operational improvements meet required specifications.
* Coordinate with EPCM teams to ensure alignment of engineering deliverables with technical and operational requirements.
* Provide guidance and support to production staff implementing operational improvements.
Quality and Compliance Oversight:
* Ensure that all project activities comply with GMP regulations and internal quality standards.
* Collaborate 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:
* Liaise with operations, maintenance, engineering, and quality teams to ensure seamless integration of mechanical adaptations into production.
* Facilitate communication and alignment between the production staff and the EPCM to address any technical challenges or deviations.
Project Execution and Monitoring:
* Monitor the progress of technical and operational activities to ensure milestones are met on time and within budget.
* Conduct risk assessments and develop mitigation plans for potential project roadblocks.
* 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 coordinate with validation teams to ensure the effectiveness and reliability of the implemented changes
Your qualifications
* Degree in Biochemical Engineering, Mechanical Engineering, Life Sciences, or a related field.
* 5+ years of experience in biopharmaceutical manufacturing, with a strong focus on technical project management or operational excellence.
* Proven experience working on GMP-compliant projects, including change management and qualification activities.
* Hands-on experience in commissioning, qualification, and validation (CQV) of equipment and processes in a GMP environment.
* Strong knowledge of GMP regulations and biopharmaceutical manufacturing processes.
* Proficiency in project management tools and methodologies.
#J-18808-Ljbffr