Position Brand Description: The Process engineer will focus on the reliable equipment operation, process monitoring and control, and optimization of manufacturing process. The Process Engineer is a member of the Process Team in which requires interacts with Operations, Automation, Plant Engineering, Technical Service, Maintenance and Quality Assurance personnel to assure that pharmaceutical processes are executed per cGMPs with minimal variation.
The Process Engineer provides technical expertise regarding deviations, change controls, operating procedures, equipment operating parameters, equipment improvement, overall process efficiency and equipment safety for their process equipment.
Become the equipment expert and asset steward.
Ensure the Reliability of the Assets.
Knowing how the equipment affects key process parameters.
Knowing and understanding the basis of design for the equipment (user requirements).
Educating process team members and operators on equipment requirements.
Understanding potential equipment failure modes and sources, and potential countermeasures for equipment related deviations.
Knowing the safe operating limits (including ergonomic) for the process and equipment.
Understanding equipment capability.
Develop and understand process mass and energy balance models.
Understand the purpose and science of the process.
Knowing the product/process development history.
Understanding the Product Flow Diagram (PFD) and Annual Product Review (APR).
Own the qualified state of the equipment
Support qualification and equipment Periodic Maintenance Plans.
Ensuring changes, maintenance, and other interventions do not adversely affect the qualification state of the equipment.
Providing guidance on key elements of return to service requirements.
Having a holistic understanding of the process validation and its associated equipment, facilities, and computer system validations.
Assuring equipment is properly maintained.
Support the management of daily operations.
Using statistical tools to better understand and reduce the sources of variability, and continuously improve the process.
Using data historian to extract and analyze process parameters.
Being able to lead equipment related Root Cause Analysis and providing equipment expertise in all incident investigation.
Providing interface with maintenance, utilities, and automation.
Owning equipment related events, CAPAs, and changes.
Responsible for process cycle time and throughput variables.
Identifying process bottlenecks troubleshoot and determine effective countermeasures.
Knowing the sources of variability in cycle time and throughput, assisting the Process Team to identify sources of common or special cause variability.
Measuring and understanding how to improve equipment uptime.
Conducting on shift reviews with operations to ensure procedures are correct.
Where discrepancies exist, ensure practice or procedure are modified working with shift supervision and operators
Ability to organize and prioritize multiple tasks
Knowledge of computer applications (Excel, Word, Presentation)
Knowledge of Engineering Fundamentals
Experience and knowledge of cGMP requirements where both quality and safety regulations are being addressed on a daily basis
Proven ability to work well in a team environment incorporating a variety of functional relationships.
Strong communication and networking skills. Must be fluent in English.
Advocate for safety, training and knowledge sharing
With at least 5 years relevant work experience
Project experience is priority Bachelor’s degree or above in Chemical Engineering, Mechanical Engineering, process.