The Process Engineer at CAI is responsible for conceptual, basic and detailed equipment and utility design for our projects for clients in the pharmaceutical, medical device and biotech industries. This individual should also have significant experience in commissioning and qualification of clean and black utilities and/or process equipment.
CAI is a rapidly expanding professional services organization headquartered in the United States with offices in Singapore, Malaysia, South Korea, Australia, China, Ireland, Italy, Netherlands and Puerto Rico. We deliver projects in the pharmaceutical, biotechnology, medical device, and nutritional industries, providing industry best practices to our clients. Check us out at www.commissioningagents.com.
Responsibilities for the position of Process Engineer include: -
· Experience in Downstream bioprocess operations and Demonstrated experience in equipment design such as chromatography skids, Ultrafiltration & Diafiltration skid, Filtration skids, Tank farms, Autoclave, Parts washer and CIP systems.
· Active participation in Basic &Detail design, Commissioning and Qualification phase of the project.
· Demonstrate ability to support the project from concept through implementation and working with Process Engineering team and EPCM Contractors.
· Coordinates with multi-disciplinary team like Automation, Manufacturing, PDTS and Validation for improvements or implementing changes associated with projects.
· Responsible and adhere to any applicable EHS requirements.
The successful Process Engineer must have:
· Minimum Bachelor Degree in Chemical, Biotechnology or Biochemical Engineering.
· 3 to 5+ years of experience in Downstream bioprocess operations and Demonstrated experience in equipment design in Pharmaceutical/biopharmaceutical industry.
· Experience in an engineering role supporting cGMP operations in a Pharmaceutical/biopharmaceutical manufacturing plant is highly desirable.
· Experience in the design and operation of biopharmaceutical manufacturing equipment and facilities.
· Experience in the management and coordination of engineering and construction management consultants, equipment vendors and contractors.
· Process and equipment knowledge of biological drug substance manufacturing processes; downstream unit operations expertise highly preferable.
· Read &Understand PCS7 Functional Specification and Knowledge/ Experience in Siemens PCS7 is preferable.
· Knowledge/ Experience in DeltaV, is an added advantage.
· Understanding equipment commissioning, various stages of qualification and process activities.
· Thorough knowledge of current Good Manufacturing Practices (cGMP) and Good Engineering Practices (GEP).
· Good understanding of design principles and standards within the biopharmaceutical facilities.
· Strong knowledge of sanitary design aspects of biopharmaceutical manufacturing equipment’s. Proficiency in MS Office applications.
· Excellent communication (written and verbal) in English.
· Willingness to travel up to 50% of the time.
In return for your skills and knowledge, CAI offers a wide range of benefits including:
· Full time permanent position with a very competitive package
· ESOP, medical, company paid life insurance and more
· Paid time off
· Continuing education (internal and external)