Junior Process Engineer
4 weeks ago
About NdIncorporated
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.
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 Next Generation Manufacturing 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:
Bachelors Degree in Science and 2 years of experience directly related to the job OR Associates 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 Reg. No : R2094147 EA License No : 19C9587
Recommended Skills:
Automation, Biopharmaceuticals, Cell Cultures, Communication, Corrective And Preventive Action (Capa), Maintenance
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