We have been engaged to find an experienced Process or R&D Engineer with a minimum of 5 years of hands on experience in scale up from product development to pilot plant and on to commercialization. Excellent opportunity to make an immediate impact with great company. . .put your Engineering and process management skills to work in a new role today!
Responsibilities include:
• Involved in new product scale-up, process optimization, technology transfer and process validation activities
• Develops and implements manufacturing processes for clinical and non-clinical product
• Develops a deep understanding of the manufacturing process and how it affects the product performance
• Designs, builds, acquires and maintains methods and tools for process improvements
• Assists the manufacturing operation in problem solving with regards to equipment and systems
• Establishes operating equipment specifications and improves manufacturing techniques
• Develops and recommends new processes and technologies to achieve cost effectiveness and improved product quality
• Interfaces with various departments to ensure processes and designs are compatible for new product technology transfer and to establish future process and equipment automation technology
• Creates and edits manufacturing machine related documentation, including Standard Operating Procedure (SOPs) and instrument troubleshooting guides
• Creates, edits and executes protocols and writes protocol reports
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors
• Implement process controls to achieve production and quality targets
• Perform IQ/OQ/PQ qualifications for equipment and processes
• Perform weekly inspections of hazardous waste containers
• May transport hazardous waste from satellite accumulation area to chemical waste storage room
The qualified candidate will have:
• Demonstrated experience with CPK, tech transfer, data analysis and process / manufacturing troubleshooting
• 5+ years medical device or pharmaceutical manufacturing, experience in drug combination therapy processes is ideal
• BS /MS Mechanical Engineering, Chemical Engineering, or related discipline
• Excellent communication skills and problem solving skills
• Solid knowledge of current Good Manufacturing Practices (cGMP) applicable to the FDA and comparable international regulatory agencies
• Ability to plan and schedule multiple projects and tasks
• Good knowledge of MS Office Suite and MS project and basic knowledge of Solid Works
Industry: Pharmaceutical, Biotechnology, Medical Device, Process, Engineering, GMP, Validation, Scale-up, Tech Transfer, Solid Works