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/guidelines.
System Boundary development + approval.
Design Qualification preparation, execution and approval. Includes release for IQ.
GMP-RA's.
Commissioning 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/guidelines.
Shall be able to work / support another C&Q activity if deemed necessary.
Proactive in problem solving.
Knowledge of Interface Management.
Carry out shift work, where required.
Candidate Profile:
Bachelor's degree in Life Sciences or Engineering
At least 5+ years of experience in commissioning and qualification
Experience with DeltaV (Emerson) and other Control Systems
Experience with COMOS/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