CQV Engineer - Spark Life Solutions Inc

Syracuse, NY 13202

Roles & Responsibilities:

Lead and execute commissioning of new or modified equipment and systems, including freezers, mixers, incubators, biosafety cabinets, refrigerators, water for injection systems, and compressed air systems.
Develop and implement commissioning protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for the specified equipment.
Collaborate with cross-functional teams, including engineering, quality, and production, to ensure seamless commissioning and integration of equipment and systems into existing processes.
Develop and execute qualification and validation strategies for critical equipment, ensuring compliance with FDA, EMA, and other global regulatory requirements.
Author, review, and approve qualification and validation documentation, including Validation Master Plans (VMPs), IQ/OQ/PQ protocols, and final reports for equipment such as freezers, incubators, and water for injection systems.
Conduct risk assessments, process mapping, and gap analyses to identify potential risks in equipment performance and ensure effective mitigation strategies are implemented.
Ensure that freezers, mixers, incubators, biosafety cabinets, refrigerators, water for injection systems, and compressed air systems are validated to operate within specified parameters.
Analyze and interpret data from equipment qualification and validation activities to confirm that processes and equipment perform as intended.

Education & Experience:

Bachelor's degree in Engineering, Life Sciences, or a related field; advanced degree preferred.
Minimum of 4-6 years of experience in CQV roles within the pharmaceutical or biotechnology industry, with specific experience in equipment such as freezers, mixers, incubators, biosafety cabinets, and water for injection systems.
Strong knowledge of cGMP, FDA regulations, EMA guidelines, and industry standards related to CQV.
Proven experience with equipment and process qualification, including IQ/OQ/PQ, in a pharmaceutical manufacturing environment.
Excellent problem-solving skills and the ability to analyze complex data to drive decision-making.
Strong project management skills, with experience managing multiple projects simultaneously.
Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment.
Proficiency in using validation software and tools, as well as MS Office Suite.

Source : Spark Life Solutions Inc