The role will support a project involving mechanical adaptations and operational improvements in an existing mammalian commercial production line. The Scheduler will be responsible for developing, maintaining, and coordinating project schedules, ensuring alignment between engineering, operational, and compliance activities. This position is critical to ensuring project milestones are met and that all deliverables adhere to GMP (Good Manufacturing Practices) standards.
Key Responsibilities
Schedule Development & Management:
• Develop and maintain a comprehensive project schedule from conceptual design to performance qualification (PQ), capturing both mechanical adaptations and operational improvements.
• Integrate Engineering, Procurement, Construction Management (EPCM) timelines with operational and compliance-driven activities.
Coordination & Collaboration:
• Act as the central point of coordination between EPCM teams, production staff, quality assurance, and compliance teams.
• Facilitate alignment of GMP change management activities (e.g., TCRs, CRs) with project milestones and deliverables.
Monitoring & Reporting:
• Monitor progress against the schedule, identify potential risks or delays, and propose corrective actions to maintain project timelines.
• Provide regular updates and progress reports to stakeholders, highlighting critical path activities and potential bottlenecks.
Compliance Integration:
• Ensure that compliance-related activities such as TCRs, CRs, and PQ are well integrated into the schedule.
• Collaborate with QA/QC teams to ensure all operational activities meet GMP requirements and are completed on schedule.
Risk Management:
• Identify scheduling conflicts, resource constraints, and other risks early, proposing solutions to minimize impact on project timelines.
Tools & Systems:
• Utilize project management software (e.g., Primavera P6, MS Project, or equivalent) to build and manage schedules.
• Ensure that the scheduling process adheres to internal project management standards and regulatory requirements.
Qualifications:
Education & Experience:
• Bachelor’s degree in Engineering, Life Sciences, Project Management, or a related field.
• Minimum 3-5 years of experience in scheduling within a regulated (GMP) environment, preferably in the pharmaceutical or biopharmaceutical industry.
Technical Skills:
• Proficiency in project scheduling tools (e.g., Primavera P6, MS Project).
• Strong understanding of GMP compliance, including change management (TCRs, CRs) and validation activities (IQ/OQ/PQ).
• Familiarity with biopharmaceutical manufacturing processes, particularly mammalian production systems, is a plus.
Soft Skills:
• Exceptional organizational skills with keen attention to detail.
• Strong communication and interpersonal skills to collaborate effectively with multidisciplinary teams.
• Problem-solving mindset and ability to adapt to changing priorities.
Other Requirements:
• Demonstrated ability to manage complex schedules with multiple interdependent activities.
• Understanding of EPCM project frameworks and their integration with operational processes.