Process Engineer - (190001N4)
Piramal Pharma Solutions is the Contract Development and Manufacturing arm of Piramal Enterprises Ltd., with operations across North America, Europe and Asia. We are a global leader in integrated solutions and offer a unique platform of services across the drug lifecycle – from drug discovery and development to commercial manufacturing of drug substances and drug products. Our capability as an integrated service provider & experience with various technologies enable us to serve innovator and generic companies worldwide.
- 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.
- Identifies and drafts Experimental, Development, and Operational Studies to expand expertise in parenteral manufacturing.
- Independently ensures that work is performed in an accurate, timely, and efficient manner.
- Identifies areas for improvement in and compliance with company policies, SOPs, cGMP regulations, and FDA regulations.
- Takes a lead in resolving deviations, investigations and continuous improvements to improve processes, quality, costs, safety and/or cycle time.
- Leads teams, including representatives from Operations, Validation, Quality Assurance groups and Formulation Development, to integrate new components and/or processes into the existing manufacturing environment.
- Relies on experience and judgment to plan and accomplish goals.
- Performs a wide variety of mechanical and chemistry related tasks.
- May lead and direct the work of others.
- Creativity and latitude is expected.
- Troubleshoots and investigates manufacturing problems, monitors the processes and optimizes processes as required.
- Proactively identify where gaps in SOPs and setups exist; assist, and sometimes lead, in closing gaps.
- 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.
- 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.
- Recommend, justify, 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
- 70% Computer/office work.
- 30% in a clean room or laboratory environment.
- Position may require extended hours including evenings and weekends, travel between multiple work sites.
Piramal Pharma Solutions provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
- B.S. Chemical or Mechanical Engineering + 5 – 8 years experience
- Familiar with a variety of the field's concepts, practices, and procedures.
- In-depth knowledge of pharmaceutical parenteral manufacturing principles and packaging equipment.
- In-depth knowledge of regulatory guidelines and requirements.
- Experience in contract manufacturing environment preferred.
- Experience in lyophilized and aseptic product validation is desirable.
- Ability to lead a cross-functional team which may include operations, quality assurance, validation, and laboratory.
- Effective at leading collaboration with others to obtain the desired organizational objectives.
- Excellent listening skills
- Good oral and written communication skills, especially with external interactions.
- Able to handle multiple complex tasks and set priorities with multiple internal customers.
- Excellent working knowledge of MS Excel, Word, and Visio, including formulas and graphing functions.
- Experience in process development and scale-up required.
Lexington 1500 BULL LEA ROAD, SUITE 250 Lexington 40511
19-Nov-2019, 7:02:30 AM