Operation Cleaning BPE

Manufacturing Operations Cleaning BPE

Role Overview: This position focuses on overseeing and optimizing cleaning operations in a GMP-compliant manufacturing environment, particularly within a mammalian asset that is in its startup phase. The expert will be responsible for managing the cleaning processes, ensuring regulatory compliance, leading operational teams, and driving continuous improvements across cleaning in manufacturing operations.

Key Responsibilities:

Cleaning Operations & Documentation:

• Guide and support the team in implementing and optimizing cleaning processes, ensuring all documentation meets regulatory compliance requirements.
• Ensure timely, high-quality preparation, creation, optimization, control, and review of manufacturing cleaning-related documents (e.g., Recipes, EBRs, SOPs) in alignment with local procedures.
• Review and prepare quality records, such as change requests (CRs), deviation reports (DRs), CAPAs, and ensure their timely and accurate processing.

Audit & Regulatory Compliance:

• Act as the Manufacturing Operations representative and subject matter expert (SME) during internal and external audits, ensuring compliance with GMP standards.
• Support and/or execute risk assessments for the cleaning processes related to assigned products and systems to identify areas for improvement and mitigate risks.

Training & Operational Expertise:

• Collaborate with the MSAT (Manufacturing Science and Technology) and QA cleaning validation group to improve cleaning process robustness and drive process optimization in routine manufacturing.
• Represent manufacturing from the cleaning perspective in the realization of investment projects.
• Assist in the creation of training strategies, resources, and the training of production staff on proper cleaning processes and procedures.

Internal Projects & Process Improvements:

• Represent Manufacturing in various internal projects, providing input for the setup, commissioning, and qualification of manufacturing cleaning processes.
• Support the optimization of workflows and processes through continuous improvement methodologies such as Lean Six Sigma, Kaizen, and KPI tracking to drive operational excellence.

Production Support & Supervision:

• Collaborate with the cleaning managers, MSAT, QA, and validation teams to plan, implement, and report on cleaning activities.
• Supervise GMP production and provide organizational oversight to ensure cleaning activities are performed correctly and timely.
• Ensure the production areas remain technically flawless, clean, and qualified, in compliance with safety, hygiene, environmental, and quality requirements.

Collaboration & Risk Management:

• Support production planning with the Associate Director of Manufacturing, Bioprocess Engineers, MES/DeltaV Specialists, and Manufacturing Line Specialists regarding cleaning schedules and activities.
• Lead or participate in root cause analysis, CAPA definition, and change implementation processes within the GMP environment to address any issues related to cleaning.
• Carry out risk analyses and ensure that all cleaning operations are carried out safely, efficiently, and in compliance with the highest industry standards.

On-Call Duty & Customer Support:

• Ensure production services and safety during on-call duties outside regular working hours, addressing any emergency situations or cleaning-related needs as they arise.
• Participate in meetings, inspections, and audits as the plant representative to provide expert support and ensure customer satisfaction.

Key Skills:

• GMP & Compliance Expertise: In-depth knowledge of Good Manufacturing Practices (GMP) and regulatory requirements for cleaning processes, including documentation, validation, and audit readiness.
• Process Optimization & Continuous Improvement: Strong background in driving process improvements using Lean Six Sigma, Kaizen, and other methodologies to enhance cleaning efficiency and quality.
• Cross-Functional Collaboration & Project Management: Ability to work effectively across teams (MSAT, QA, bioprocess engineers) and manage internal projects, from cleaning system setup to qualification.
• Training & Team Leadership: Skilled in developing and delivering training programs for production staff, and leading teams to ensure compliance with cleaning protocols.
• Problem-Solving & Risk Management: Expertise in conducting risk assessments, performing root cause analysis, and implementing corrective actions to mitigate operational risks and maintain safety standards.