Cleaning Operations Specialist

Key Responsibilities:

• Cleaning Operations & Documentation:

  • Guide and support teams in implementing and refining cleaning processes.
  • Prepare, review, and optimize cleaning-related documents (recipes, EBRs, SOPs, change requests, deviation reports, CAPAs).

• Audit & Regulatory Compliance:

  • Serve as the subject matter expert during internal and external audits.
  • Execute risk assessments to identify and mitigate process vulnerabilities.

• Training & Operational Expertise:

  • Collaborate with MSAT and QA to enhance cleaning process robustness.
  • Develop and deliver training programs for production staff on cleaning protocols.

• Process Improvement & Project Management:

  • Represent Manufacturing in projects related to cleaning system setup, commissioning, and qualification.
  • Drive workflow optimizations using Lean Six Sigma, Kaizen, and KPI tracking.

• Production Support & Supervision:

  • Coordinate with cleaning managers, QA, and validation teams to plan and execute cleaning activities.
  • Oversee on-site troubleshooting, visual inspections, and corrective actions; manage cleaning sampling procedures (Pronas).

• Collaboration & Risk Management:

  • Support production planning and lead or participate in root cause analysis and CAPA processes.
  • Ensure all cleaning operations are executed safely and efficiently.

• On-Call Duty & Customer Support:

  • Provide emergency support during on-call duties and represent the plant during inspections and audits.

Key Skills & Qualifications:

• Extensive knowledge of GMP and regulatory requirements for cleaning operations.
• Experience in managing cleaning operations within a manufacturing environment, preferably in a mammalian asset startup.
• Background in Manufacturing Operations, Bioprocess Engineering, or related fields.
• Strong documentation, audit, and risk management skills.
• Proficiency in process improvement methodologies (Lean Six Sigma, Kaizen).
• Excellent communication, team leadership, and cross-functional collaboration abilities.