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détails du poste

For our client Merck in Aubonne, we are looking for a Cleaning Validation Expert (m/f/d) for a period of 12 months.

Your Role :

Coordinate cleaning validation and monitoring activities in line with the life cycle of a manufacturing process for biotech manufacturing equipment
Establish and execute validation protocols and reports for cleaning validation
Ensure reliability and conformity of validation and control activities in line with internal and regulatory procedures and guidelines
Provide technical support to cleaning activities associated with the manufacturing process.
Perform successful and on time resolution of incidents and deviations related to cleaning validation exercises (Investigates and conducts troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results)
Support the periodic process review and etablish documentation relation to control of the process (PCS, sampling plans and commercial panel testing )
Lead the enhancement of cleaning practices
Share best practices and train teams
Be cleaning Expert during audits and inspections

Who You Are:

Bachelor's or Master's Degree in Science, Pharmacy or Engineering.
Minimum of 5 years of professional experiences in cleaning validation in the pharmaceutical and biotechnology industries.
Fluent in english and french
Proficient knowledge of cleaning validation, continuous process improvement and troubleshooting processes.
Proficient time management skills, planning and organization capabilities.
Proven leadership & teamwork skills, self starter, results oriented and build and maintain strong relationships with multiple groups.
Proficient in Risk Assessment/Management Proven assessment, analytical and problem-solving skills.
Proficient presentation skills and Technical Writing/Oral communication skills (English) Proficient in cGMP's, and FDA Regulations as it applies to pharmaceutical industry.

For our client Merck in Aubonne, we are looking for a Cleaning Validation Expert (m/f/d) for a period of 12 months.

Your Role :

Coordinate cleaning validation and monitoring activities in line with the life cycle of a manufacturing process for biotech manufacturing equipment
Establish and execute validation protocols and reports for cleaning validation
Ensure reliability and conformity of validation and control activities in line with internal and regulatory procedures and guidelines
Provide technical support to cleaning activities associated with the manufacturing process.
Perform successful and on time resolution of incidents and deviations related to cleaning validation exercises (Investigates and conducts troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results)
Support the periodic process review and etablish documentation relation to control of the process (PCS, sampling plans and commercial panel testing )
Lead the enhancement of cleaning practices
Share best practices and train teams
Be cleaning Expert during audits and inspections

Who You Are:

Bachelor's or Master's Degree in Science, Pharmacy or Engineering.
Minimum of 5 years of professional experiences in cleaning validation in the pharmaceutical and biotechnology industries.
Fluent in english and french
Proficient knowledge of cleaning validation, continuous process improvement and troubleshooting processes.
Proficient time management skills, planning and organization capabilities.
Proven leadership & teamwork skills, self starter, results oriented and build and maintain strong relationships with multiple groups.
Proficient in Risk Assessment/Management Proven assessment, analytical and problem-solving skills.
Proficient presentation skills and Technical Writing/Oral communication skills (English) Proficient in cGMP's, and FDA Regulations as it applies to pharmaceutical industry.

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Cleaning Validation Expert -DS (all genders).

détails du poste