Process Engineer I

About the role

TekniPlex is hiring a Process Engineer I for our Clayton, NC facility. The Technical Operations/Process Engineer will manage and execute assigned Level 1 & 2 technology projects, including the introduction and execution of new product programs for prototypes and validations. They will also provide technical assistance to support manufacturing operations Level 0 projects.

Responsibilities

• Lead/support/conduct IQ, OQ, PQ validation studies of equipment and processes validations.
• Select and utilize a wide range of appropriate statistical methodologies and techniques.
• Participate on technical project teams as subject matter expert on validation regulations/procedures.
• Give advice to project teams, develop/review and approve validation protocols and final reports.
• Provide manufacturing support to the Technical Operations team in the design and development of new processes and products within the Plants and other sites, if necessary.
• Design process characterization studies, conduct statistical analysis of results using Minitab or equivalent to identify critical parameters and improve process capability.
• Develop processes and procedures to train peers within the Technical Operations, Quality and Production teams along with educating associates in the ongoing sustainment of continuous improvement.
• Support the response to customer quality concerns, following six-sigma methodology to determine root cause of problems and implementing sound corrective actions.
• Review equipment manuals, specifications, drawings and operational documents to ensure validation and qualification protocols and standard operating procedures are in-line with manufacturer’s specifications, operational procedures, calibration requirements and required maintenance.
• Ensure change control procedures are being followed with respect to facility, equipment and utility changes and provide adequate oversight and follow-up on validation deviations both in terms of content (root cause) and in terms of CAPA.
• Perform periodic assessment of validation/qualification procedures and policies.
• Write and edit validation/qualification protocols and SOPs.
• Works with sales, quality and engineering personnel to devise action plans for new product development or quality correction needs.
• Recommend methods and technologies for process improvement based on manufacturing needs and capabilities.
• Assist with client and QA audits by explaining validation and qualification activities performed at the site.
• Work closely with stakeholders (project management) to identify potential process options, determine process capability, and validate that the outside processes meet design requirements.
• Aid in the development of technical specifications for future projects and technologies.
• Input all projects onto the Knowledge Management log for review during technical and process engineering meetings.
• Record project scope, results, and findings with attention to detail.
• Store all closed projects on a shared site for access by the global technical and operations teams.
• Other duties as assigned.

Qualifications

• A bachelor’s degree in a related engineering field such as Plastics, Mechanical, or Industrial Engineering is required.
• Background must include experience in more than one of the following areas: extrusion, medical device manufacturing, extrusion, injection molding, process improvement, industrial manufacturing.
• A solid knowledge of plastics is preferred.
• Experience in extrusion or injection molding is recommended.
• Experience with process development and process validation.
• Demonstrate strong decision-making skills, sound judgment and the ability to adapt to a rapidly changing work environment.
• Effective communication, listening, and diagnostic skills are required to communicate with customers, consultants as well as with internal team members from various departments.
• Ability to learn how equipment functions and then design appropriate validation/qualification protocols.
• Understanding of application for DOE, DFMEA, and PFMEA methodologies.
• Experience with Statistical Process Control methods (control charts, Cpk’s etc.).
• Knowledge of good manufacturing practices (GMP’s) encompassing plastics extrusion lines, and calculations of speeds, material composition understanding, comprehension of the basic function of fixtures and familiarity with inspecting and checking methods.
• Proficient in GD&T and metrology.
• Ability to read and interpret prints and tool designs.
• Ability to troubleshoot solve problems independently or as part of a team.
• Excellent verbal and written English (B2) communication skills - Ability to internally and externally discuss and clearly define key technical and process development issues and independently develop course of action/plans.
• Ability to work well independently and as a member of a team is essential.
• Individual must be hands on and willing to work in the production environment including off shifts when projects require.
• The ability to travel to all divisional locations to support product and process related projects when required; will report to offsite supervisor.
• Knowledge of Six Sigma is required and certification is a plus.