We are seeking a highly skilled and motivated Commissioning & Qualification Engineer to join our Quality Control (QC) Laboratory project team.
Job Summary:
The successful candidate will be responsible for ensuring the successful commissioning, qualification, and ongoing validation of laboratory equipment, systems, and processes to comply with regulatory standards and ensure the highest levels of quality.
Key Responsibilities:
* Plan, coordinate, and execute commissioning, and qualification activities for QC laboratory systems, equipment, and support utilities as needed.
* Coordinate execution activities with supporting CSV Team and global IT teams.
* Lead C&Q testing activities supported by external vendors and/or contractors.
* Develop any supporting validation plans related to scope of execution.
* Develop and review Qualification Protocols (IQ/OQ/PQ), commissioning documents, and final reports, ensuring compliance with relevant standards (GxP, FDA, EMA, ISO, etc.).
* Support the updates of Master C&Q Plan and supporting plans during project execution lifecycle.
* Maintain and report C&Q status to the C&Q Lead.
* Identify potential risks or issues during commissioning and qualification activities and lead troubleshooting efforts when necessary.
Candidate Profile:
The ideal candidate will have:
* A Bachelor's degree in Life Sciences or Engineering.
* At least 5 years of commissioning, qualification, or validation experience in a GMP environment in a Life Sciences relevant discipline.
* Familiarity with laboratory instruments such as HPLC, GC, UV-Vis spectrophotometers, and other analytical equipment.
* Experience with computer systems validation (CSV) for laboratory systems.
* Strong knowledge of qualification and validation processes for laboratory systems and equipment.
* Excellent written and verbal communication skills.
* cGMP knowledge and knowledge of regulatory requirements.