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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