Regulated Manufacturing Scheduler
Vor 5 Tagen
We are seeking a skilled Regulated Manufacturing Scheduler to join our team at Capgemini Engineering. As a key member of our team, you will be responsible for developing and maintaining project schedules, ensuring alignment between engineering, operational, and compliance activities.
Your Key Responsibilities:- Develop and Maintain Schedules: Create and update project schedules from conceptual design to performance qualification (PQ), incorporating engineering, procurement, and compliance timelines.
- Collaborate with Stakeholders: Work closely with EPCM, production, QA, and compliance teams to ensure GMP change management activities align with project milestones.
- Monitor Progress and Identify Risks: Track progress, identify potential risks, and propose corrective actions to meet deadlines; provide regular updates to stakeholders.
- Ensure Compliance Integration: Guarantee schedules accommodate GMP compliance, working with QA/QC to meet requirements on time.
- Manage Scheduling Conflicts: Identify and resolve scheduling conflicts and resource constraints.
- Utilize Scheduling Tools: Leverage scheduling tools (e.g., Primavera P6, MS Project) and adhere to internal and regulatory standards.
About Our Ideal Candidate:
- 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.
- 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.
- Exceptional organizational skills with keen attention to detail.
- Problem-solving mindset and ability to adapt to changing priorities.
- Demonstrated ability to manage complex schedules with multiple interdependent activities.
- Understanding of EPCM project frameworks and their integration with operational processes.
- Excellent oral and written language skills in English.
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