At Aptyx, a new name backed by 70 years of expertise, we bring together the aptitude and excellence of more than a dozen companies with decades of experience helping customers in the life sciences and other demanding industries solve complex manufacturing problems with confidence so they can create more good things in the world. We make it happen through our integrated, comprehensive capabilities including engineering, molding, extrusion, coatings, and assembly across our global network of 14 manufacturing locations.
To support its growth strategy, Aptyx Trenton is seeking to fill the role of a Process Engineer at our Trenton location. We are looking for an industry experienced individual who will hit the ground running.
Main functions:
The primary function is to ensure the operation's performance integrity and compliance with customer expectations of all products manufactured at Aptyx. The Process Engineer participates in and improves overall efficiency, quality, productivity, and cost of existing processes, as well as being a part of the launch of new processes.
Responsibilities and Duties
Shall use the latest methods of GMP to continually improve throughput and process capability. To accomplish this, the Manufacturing Engineer will use the following Engineering disciplines:
- Process Flow and Process Flow Analysis
- Tooling Planning, Acquisition and Maintenance
- PFMEA to establish process risk of failure
- Develop core process standards and drive toward process optimization
- Participate in OEE and Capacity Improvement Teams. Conduct trials in support of process improvement. Conduct Validation evaluations on equipment and machinery according to ISO 13485 regulatory requirements. This would include analyzing key data from a run and assembling an improvement strategy for the next run.
- Automation and Robotics development for line enhancement and New product development
- Participate in 8D and other problem-solving events. To preserve the outcome of the 8D team, update the process documentation to prevent a recurrence.
- Help to create and maintain tooling and machine drawings in an organized way. Draft, layout, and specify technical devices, parts, and equipment by providing documentation, detailed instructions, drawings, or specifications to define for others how devices, equipment, or structures are to be manufactured, assembled, modified, maintained, or used.
- Troubleshoot process issues and understand the root cause of problems to identify improvement opportunities.
- Participate in Ergonomics and safety improvement teams.
- Be role models in support of company objectives, policy and procedures and safety guidelines.
Employment and Educational Requirements:
· Embrace high-performance team principles
· BSc in Engineering with experience in new program/systems development.
· Has 5 years of relevant professional experience, in the medical device industry and regulatory compliance requirements.
· Experience in Plastics materials & extrusion processing is an asset.
· Process development, safe manufacturing processes, and facility design (AutoCAD preferably SolidWorks 3D)
· Process validation; Installation Qualification (IQ), Operational Qualification (OP), and Product Qualification (PQ)
· Good Manufacturing Practices (GMP), Good Documentation Practices (GDP).
· Microsoft Office; Word, Excel, PowerPoint, Access, and Visio.
· Optimize and troubleshoot systems.
· Minitab Software and Statistical Process Control.
Competency Profile
- Self-motivated, safety motivated, continuous learner, and highly organized with the ability to manage multiple and concurrent priorities.
- Excellent interpersonal skills, professional attitude, and the ability to interact with various individuals and present information effectively to an audience of various technical backgrounds.
- Automation & Robotics implementation experience
- Advanced negotiation skills, analytical, and problem-solving abilities.
- Data driver, customer-oriented, and not reluctant to take the lead.
- Excellent influencing and decision-making abilities.
- Results-oriented with the ability to balance other business and departmental strategic goals and objectives with their own.
