Process Engineer II - (190000W0)
- To design and efficiently transfer new processes into manufacturing, to optimize existing processes, and ensure that production goals in terms of quality, yield, capacity, and timelines are met.
- Drafts Experimental, Development, and Operational Studies to expand expertise in parenteral manufacturing.
- Ensures that work is performed in an accurate, timely, and efficient manner, and in compliance with company policies, SOPs, cGMP regulations, and FDA regulations.
- Contributes to resolving deviations, investigations and continuous improvements to improve processes, quality, costs, safety and/or cycle time.
- Interfaces with Operations, Validation, Quality Assurance groups and Formulation Development to identify new components and/or processes into the existing manufacturing environment.
- Relies on limited experience and judgment to plan and accomplish goals.
- Performs a variety of tasks.
- Works under general supervision.
- A certain degree of creativity and latitude is required.
- Develops processes and implements improvements related to new and existing products.
- Leads development activities, experiments, startups, etc.
- Take initiative to develop and improve procedures and setups through the change control process.
- Prepares and reviews technical documents to include but not limited to: Technical Reports, SOP's, Master Batch Records (MBR's), Change Controls, Cost Quotes, Product and Process Verification/Validation Protocols.
- Contributes to investigations and deviations related to manufacturing, defines root causes and implements corrective actions.
- Troubleshoots and investigates manufacturing problems, monitors the processes and optimizes processes as required.
- Maintains awareness of current developments in the functional discipline. Develops a network of outside contacts such as vendors, consultants, educators and appropriate continuing education courses.
- Reviews current and new processes; applies state-of-the art technology to our processes.
- Coordinate line activities with other functions such as maintenance and downstream manufacturing events.
- Recommends, justifies, demonstrates and implements new manufacturing technologies as they become available.
- Maintains documentation on all projects and submit written reports in a timely fashion.
- Interfaces with other operating units within and outside the department. Presents ideas and suggestions for product and/or process, equipment improvements, improved Laboratory and Manufacturing operations.
- Train Manufacturing staff on new processes and/or equipment technologies.
- Ensure efficient operations in assigned project areas in accordance with OSHA Safety Requirements, SOP's and GMP's. Ensures functional operation and preventative maintenance of equipment to reduce/eliminate accidental injury.
- Interacts with external vendors.
- Independently plan and organize non-routine tasks. Initiates and maintains work schedule. Follow-through on priorities of work assignments.
- Exercises judgment in selecting innovative, practical methods to achieve problem resolution.
- 60% Computer/office work.
- 40% in a clean room or laboratory environment.
- Position may require extended hours including evenings and weekends, travel between multiple work sites.
- B.S. + 2 – 5 years experience, M.S. + 0 – 3 years experience in Mechanical or Chemical Engineering or similar. 0 to 5 years related experience and/or training; or equivalent combination of education and experience.
- Familiar with standard concepts, practices, and procedures within the field.
- Knowledge of pharmaceutical parenteral manufacturing principles and packaging equipment.
- Awareness of regulatory guidelines and requirements.
- Ability to work independently on a cross-functional team which may include operations, quality assurance, validation, and laboratory.
- Effective at collaborating with others to obtain the desired organizational objectives.
- Good listening skills
- Good oral and written communication skills, especially with external interactions.
- Able to handle multiple complex tasks and follow priorities with multiple internal customers.
- Strong working knowledge of MS Excel, Word, and Visio, including formulas and graphing functions.
- Experience in process development and scale-up desired.
Lexington 1500 BULL LEA ROAD, SUITE 250 Lexington 40511
10-Apr-2019, 7:45:41 AM