About Nd

Incorporated in 2007, we are a patient-centric solution provider for the pharmaceutical industry. We are experts in engineering consultancy, commissioning, qualification and validation services, and regulatory quality/compliance in Asia and Europe.

We offer personalized focused solutions for the pharmaceutical industry in engineering consultancy and regulatory quality and compliance. With a sharp focus on delivering value-adding commissioning, qualification, and validation services, we are leading experts in developing the lean CQV methodology. We extend our offerings to GMP-certified software for environmental monitoring and contamination control, paperless validation, training, and professional recruitment services.

We place keen attention on patient safety, process understanding, regulatory compliance and efficiency in the areas of safety, quality, delivery, and cost.

At No deviation, we strive to deliver our best every day. We apply our core values of empathy, integrity, and transparency to every activity, including engagement with our candidates. We are an equal opportunity employer, value diversity, and promote inclusivity at our company. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

We are hiring for a Process Engineer to support one of our clients who is a global leader in the design, engineering, and delivery of facilities for high-tech industries. The Engineer is overall responsible as an Equipment System Owner for several Biotechnology process equipment and single use systems as well as provide technical support to day-to-day manufacturing activities.

Responsibilities:
Applying engineering principles to recommend, design, and implement new equipment or system modifications.
Working closely with multiple disciplines, including manufacturing, engineering, utility operations, maintenance, quality assurance, and validation to implement operational improvements
Providing technical support to commercial manufacturing as needed \xef\x82\xb7 Troubleshooting and resolve equipment, automation, or process issues in the field
Ensuring optimal and cost-effective performance and reliability for process systems
Developing, organizing, analyzing, and presenting results for operational issues and engineering projects of moderate scope and complexity
Communicating proactively with supervisor and support staff, highlighting issues and proposing solutions
Technical expert who helps introduce advanced technologies and approaches generally described as \xe2\x80\x9cNext Generation Manufacturing\xe2\x80\x9d \xe2\x80\x93 into the plant.
Manage change controls, corrective actions and preventative actions associated process equipment
Manage the implementation, development and changes associate with process equipment Commissioning, Qualification and validation
Prepare, coordinate, and present complex information at cross-functional team meetings, teleconferences, and management reviews
Provide on-call support

What you will need:
Bachelor\xe2\x80\x99s Degree in Science and 2 years of experience directly related to the job OR
Associate\xe2\x80\x99s Degree in Science and 4 years of experience directly related to the job OR
High School Diploma in Science / GED and 6 years of experience directly related to the job
Extensive knowledge of Mammalian Cell Culture, Protein Purification, Single Use Systems
Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) including detailed understanding of cGMPs.
Familiarity with designing and operating equipment used in biopharmaceutical manufacturing

EA License No : 19C9587