Cleaning Process Validation (M/F)

Joining Meent means? Joining an engineering company expert in Life Science, created in 2023, which values the talent and energy of its employees to carry out innovative and ambitious projects.

At Meent Life Science, we build an adventure with our employees based on:

• Mutual aid and team spirit
• Benevolence and stability
• Fulfillment and professional progression

We believe that a fulfilled employee is a high-performing employee. That is why we offer a stimulating environment, training opportunities, and long-term support in your career.

The position:

As part of the MSAT department, you will work on manufacturing process validation activities and cleaning validation, with a particular focus on semi-automatic washer-type equipment.

Your main missions will be as follows:

• Lead manufacturing and cleaning process validation activities, while respecting cost, quality, and deadline objectives
• Participate in the implementation and/or validation of washers, particularly in a semi-automatic context
• Define validation strategies by taking into account critical process parameters
• Write the validation documentation associated with validation exercises: VMP, VP, VR, VS, etc.
• Perform risk analyses
• Perform statistical sizing of validation exercises
• Define acceptance and compliance criteria
• Utilize the results and data from validation exercises
• Update documents inherent to validation: traceability matrices, lists of validated critical parameters, etc.
• Manage system notifications to allow for change tracking
• Ensure the monitoring of validation batch manufacturing and cleaning operations
• Perform gemba in the production sectors
• Communicate the progress of handled topics, escalate blocking points, and propose corrective actions if necessary

Profile sought:

• Bac +5, such as engineering school, Master, or pharmacist with industrial specialization
• Minimum 3 years of experience in the pharmaceutical industry
• Experience in cleaning validation and/or manufacturing process validation
• Experience in cleaning validation on semi-automatic washers is strongly desired
• Good knowledge of pharmaceutical regulatory requirements: BPF/GMP, pharmacopoeias, etc.
• Operational English, both written and spoken
• Ability to work in interaction with different departments: production, quality assurance, quality control