Job Description
JOB PURPOSE:
The Process Engineer works to design and efficiently transfer new processes into manufacturing, optimize existing processes, ensuring the achievement of quality, yield, capacity and cycle time timelines.
JOB RESPONSIBILITIES:
- Drafts experimental, development, and operational studies to expand expertise in API manufacturing.
- Ensures that work is performed in an accurate, timely, and efficient manner, and in compliance with company policies, SOPs, and cGMP regulations.
- Contributes to resolving deviations, investigations and continuous improvements to improve processes, quality, costs, safety and/or cycle time for both chemistry and cleaning processes.
- Functions as the technical interface between PPS Aurora and the Client, focusing on providing technical advice and support, engineering solutions, overseeing GMP runs in the plant equipment, analyzing production data to evaluate process performance, and writing production summaries
- Interfaces with Operations and Quality Assurance groups to identify new components and/or processes into the existing manufacturing environment.
- 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 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 part of a Continuous Process Verification program
- Maintains awareness of current developments in the functional discipline
- Reviews current and new processes; applies state-of-the art technology to our processes
- 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 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, as needed
- Independently plan and organize non-routine tasks. Initiates and maintains work schedule. Follow-through on priorities of work assignments.
- Takes part in Operational Excellence activities for the plant.
- Exercises judgment in selecting innovative, practical methods to achieve problem resolution.
EDUCATIONAL AND PROFESSIONAL ATTAINMENT:
- Bachelor degree in Chemical Engineering
JOB RELATED WORK EXPERIENCE REQUIRED:
- 5+ years of experience working within pharmaceutical manufacturing/development environment, process development and scale-up, contract manufacturing strongly preferred
SKILLS AND KNOWLEDGE:
- Knowledge and understanding of cGMP requirements
- Knowledge and experience in cGMP CA/PA, root-cause analysis, risk assessment and investigation tools and techniques
- Knowledge and understanding of the regulatory approval process for US, EU, and JP
- In-depth knowledge of API manufacturing principles
- Ability work within and lead a cross-functional team which may include operations, quality assurance and laboratory personnel
- Good oral and written communication skills
- Able to handle multiple complex tasks and set priorities with multiple internal customers
- Proficiency using Microsoft Office applications (Word, Excel, PowerPoint)
CRITICAL ATTRIBUTES:
- E.H.S. Focus
- Passionately Reliable
- Rapid Responsiveness
- Innovative Efficiency
- Teamwork
- Detail Orientation
Job Types: Full-time, Permanent
Salary: $60,000.00-$100,000.00 per year
Benefits:
- Dental care
- Employee assistance program
- Life insurance
- Paid time off
- Vision care
Schedule:
- Day shift
- Monday to Friday
Ability to commute/relocate:
- Aurora, ON L4G 4C3: reliably commute or plan to relocate before starting work (required)
Education:
- Bachelor's Degree (preferred)
Work Location: In person