Cleaning Validation Engineer

For a 1 year project with our client in Schaffhausen, we are looking ASAP for a Cleaning Validation Engineer.

The Cleaning Validation Engineer will be accountable for cleaning validation of technology transfers and Legacy biologic, non-biologic and solid dosage form products.

Tasks:

* Cleaning validation expertise
* Technical support for cleaning validation
* Enhance reliability, compliance & efficiency of product value chains end to end
* Integrate Manufacturing Operations and Pharmaceutical Development in partnership with Product and Customer Management
* Write/review cleaning validation protocols/reports
* Coordinate and execute risk and gap assessments, define actions and ensure follow-up
* Support of Cleaning Validation Life Cycle Management
* Validate Manufacturing Process and Cleaning Capability/Quality/Cost Improvement Changes
* Provide technical assessments to Change Controls/CAPA's and Deviations
* Drive system improvement activities

Skills

. You have a University/Master Degree in Chemistry or Pharmacy or Equivalent
. Solid experience in Cleaning Validation
. You have at least 2 years related experience in the pharmaceutical sector
. Experience in Drug Product Manufacturing Process and Cleaning

Requirements/Techniques

. Experience in cross-contamination risk assessment tools
. Ability to operate in a complex global Matrix organization with multiple stakeholders
. Knowledge of Quality Assurance and Regulatory Compliance cGMP and EH&S
. Knowledge of the latest legislation updates with focus cross-contamination
. Fluent in both English and German
. Flexible, independent, pro-active, motivated and innovative team player with a do mentality.

Additional Information:

. Implementation risk based monitoring programme Cleaning Validation
. Impact analysis PDE implementation, global standardisation and harmonisation project