Job Title: CQV Engineer (Thermal Mapping)
Description:
We are seeking a skilled CQV Engineer to join our team in Thermal Mapping. As a key member of our organization, you will be responsible for thermal mapping activities for upstream and downstream packages, ensuring the start-up of processing facilities and ongoing operations during sustaining periods.
The ideal candidate will have a strong understanding of GMP requirements, validation processes, and temperature mapping principles. They should possess excellent communication, interpersonal, and presentation skills, with a collaborative and inclusive approach to work.
This role involves reviewing protocols and reports for equipment commissioning and qualification activities, coordinating temperature mapping and validation of various equipment, and maintaining SOPs and WIs associated with qualification and validation studies.
The successful candidate will also ensure that project-related work is carried out in accordance with validation policies, guidelines, site validation master plans, and GMP standards. Additionally, they will be responsible for generating reports and analyzing data against predetermined criteria to meet GMP standards.
Key Responsibilities:
* Review Protocols / Reports for Equipment Commissioning & Qualification activities on-site
* Coordinate/perform all temperature mapping and validation of equipment
* Maintain SOPs / WIs associated with Qualification & Validation studies
* Evaluate project-related work according to Validation Policies, Guidelines, Site Validation Master Plan, and GMP
* Conduct Sterilization / sanitization validations site-wide and temperature distribution studies as required
* Generate reports / analysis of data against pre-determined criteria to GMP standards
Requirements:
* Bachelor's degree in a life-science/engineering related discipline
* Minimum 3 years experience in thermal mapping
* Good understanding of bio-pharmaceutical industry including GMP and relevant validation requirements
* Excellent communication, interpersonal, and presentation skills
* Collaborative and inclusive approach to work
* Flexible approach to work and positive attitude
* Able to engage cross functionally in conjunction with a site-based team
* Strong ethics and adherence to company procedures and policies, regulatory standards, and customers expectations
* Demonstrate ability to drive a Continuous Improvement Culture within the Engineering team
About Us:
We are a world-class biologics services provider offering discovery through commercialization services to global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development, and manufacturing in the fast-growing field of biologics to benefit patients worldwide.
We offer a dynamic and fast-paced environment where people from diverse backgrounds and experiences are respected, and we work together to change lives. If you are interested in joining an exciting journey towards accomplishing our mission, apply now and discover your true potential.