Manufacturing Operations Cleaning Expert

Proclinical is seeking a dedicated Manufacturing Operations Cleaning Expert to oversee and enhance cleaning operations within a GMP-compliant manufacturing environment. This role is crucial for managing cleaning processes, ensuring regulatory compliance, and leading operational teams in a startup phase mammalian asset. Your expertise will drive continuous improvements in manufacturing operations.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

• Guide and support the team in implementing and optimizing cleaning processes, ensuring all documentation meets regulatory compliance requirements.
• Ensure timely preparation, creation, optimization, control, and review of manufacturing cleaning-related documents in alignment with local procedures.
• Review and prepare quality records, such as change requests, deviation reports, and CAPAs, ensuring timely and accurate processing.
• Act as the Manufacturing Operations representative during audits, ensuring compliance with GMP standards.
• Support risk assessments for cleaning processes to identify areas for improvement and mitigate risks.
• Collaborate with MSAT and QA cleaning validation group to improve cleaning process robustness and drive process optimization.
• Assist in creating training strategies and resources for production staff on proper cleaning processes.
• Represent Manufacturing in internal projects, providing input for the setup, commissioning, and qualification of cleaning processes.
• Support workflow optimization through continuous improvement methodologies like Lean Six Sigma and Kaizen.
• Collaborate with cleaning managers and other teams to plan and report on cleaning activities.
• Supervise GMP production to ensure cleaning activities are performed correctly and timely.
• Ensure production areas remain clean and qualified, complying with safety, hygiene, environmental, and quality requirements.
• Lead or participate in root cause analysis and change implementation processes to address cleaning issues.
• Carry out risk analyses to ensure safe and efficient cleaning operations.
• Ensure production services and safety during on-call duties, addressing emergency situations as needed.
• Participate in meetings and audits to provide expert support and ensure customer satisfaction.

Key Skills and Requirements:

• In-depth knowledge of Good Manufacturing Practices (GMP) and regulatory requirements for cleaning processes.
• Strong background in process improvements using methodologies like Lean Six Sigma and Kaizen.
• Ability to work effectively across teams and manage internal projects.
• Skilled in developing and delivering training programs for production staff.
• Expertise in conducting risk assessments and implementing corrective actions to maintain safety standards.

If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at a.bennett@proclinical.com.

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.