Overview
The CQ Execution Engineer is primarily responsible for the execution of the CQV activities corresponding to their project’s area and equipment.
Responsibilities
* Includes, but not limited to, execution of the following activities for the relevant systems in accordance with project procedures and guidelines.
* System Classification and Boundary development + approval.
* Design Qualification preparation, execution and approval. Includes release for IQ.
* GMP-RA's.
* Commissioning and SAT preparation, execution and approval. Includes vendor supervision on their testing scope and quality.
* Installation Qualification preparation, execution and approval. Includes release for OQ.
* Operational Qualification preparation, execution and approval. Includes release to OPS.
* Provide support in execution of Design Qualification for other direct impact systems.
* Provide support in the implementation of the Installation Commissioning process in accordance with project procedures and guidelines.
* Manage document consistency across Kneat platform and vendor documentation.
* Create Kneat protocols and templates.
* Track documentation status across multiple systems.
* Shall be able to work or support another C&Q activity if deemed necessary.
* Proactive in problem solving.
* Knowledge of Interface Management.
* Carry out shift work, where required.
Qualifications
* Bachelor’s degree in Life Sciences or Engineering.
* At least 3+ years of experience in commissioning and qualification.
* International experience preferred, especially in implementing small equipment systems in industries such as pharmaceuticals, biomanufacturing, food processing, or other regulated sectors.
* Experience with UNIFIER/KNEAT platforms.
* Fluent English language written and verbal communication skills.
* cGMP knowledge and knowledge of regulatory requirements.
* Able to work with minimum oversight fulfilling deliverables within target dates.
Preferred Requirements
* Experience with Lonza Commissioning / Qualification Approach.
* Biopharmaceutical knowledge and experience.
Seniority level
* Mid-Senior level
Employment type
* Contract
Industries
* Pharmaceutical Manufacturing
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