Process Engineer I

Imagine: A Career with Purpose and Possibility Picture this: You are part of a global team of problem-solvers whose innovations in materials science can make life better. Every day, you help turn ideas into impact using science, technology, and creativity to tackle real-world challenges. You are part of a company whose work helps improve patient outcomes in healthcare and protects essential consumer goods that people around the world rely on every day. At TekniPlex, you’ll join more than 8,000 colleagues across 12 countries, all united by one purpose: creating safer, smarter solutions that touch daily life. Through our two divisions, TekniPlex Healthcare and TekniPlex Consumer Products, you’ll help shape industries that matter: healthcare, pharmaceutical, food & beverage, beauty, and personal care. Here, your ideas count and your work matters. You’ll be encouraged to think boldly, collaborate across cultures, and keep growing every step of the way. You will help protect the integrity of essential products, support patient safety and comfort, and contribute to innovations that make everyday life better, all while building a career that makes an impact. Because at TekniPlex, you don’t just deliver products – you help shape what’s next.

JOB SUMMARY

TekniPlex is hiring a Process Engineer I for our Clayton, NC facility. The Technical Operations/Process Engineer is responsible for managing and executing assigned Level 1 & 2 technology projects. The engineer will handle projects related to the introduction and execution of new product programs for prototypes and validations, including processes, equipment, and tooling. The engineer will also provide, when needed, technical assistance to support manufacturing operations Level 0 projects such as continuous improvement, process optimization, and process related safety modifications. This role will be part of the team that drives projects within the plant and facilitate cross‑department communication and task execution, such as scheduling runs and gage R&R execution. This will require the individual be able to manage projects without direct report of the team members while ensuring compliance of company policies, procedures and objectives regarding processes, initiatives and projects. The technical operations/process engineer will also be responsible for championing process improvement, focusing on value stream management, quality improvement, and cost reduction. He/she will perform and oversee the validation of manufacturing processes, support the quality assurance of all activities within the process, ensuring that all systems are running according to the specifications and operational standards, monitoring budget, and controlling purchase and documentation. Daily interaction with production staff to extract and analyze operational information and perform statistical analysis to identify root cause analysis. The technical operations/process engineer may lead process improvement projects in which all departments will be represented and must be able to communicate well with all levels of personnel. This will also require that the individual be able to manage project teams without direct report of the team members. May work with the plant on cost reduction initiatives, compile appropriate information, make recommendations for action, and routinely check on results obtained. Ensures compliance with company policies, procedures, and objectives regarding processes, initiatives, and projects.

DUTIES AND 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. With a focus on manufacturability and process integration, the individual offers a manufacturing perspective to the product development team. 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. Perform gap analysis on previously performed validation/qualifications and if required, design and implement protocols to mitigate deficiencies in previous validation/qualifications. 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. Review equipment calibration and maintenance documentation and ensure Facilities is performing required calibration and maintenance in accordance with preset schedules. 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. Recommends methods and technologies for process improvement based on manufacturing needs and capabilities. Provide authoritative guidance about Lean Manufacturing and Six Sigma principles, as well as guidance in New Product Development and manufacturing. 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. Assist and/or lead 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. Must 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. 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.

LANGUAGE SKILLS

Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals. Ability to write routine reports and legibly complete time cards and work orders. Ability to read, analyze, and interpret technical procedures and read blueprints and technical drawings, such as machine, mechanical, pneumatic, hydraulic, and electrical. Ability to effectively present information in one‑on‑one and small groups situations to other employees of the organization. Ability to effectively present information and respond to questions form groups of managers, clients, customers, and the general public.

MATHEMATICAL SKILLS

Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent. Ability to apply concepts of basic algebra, geometry, fractions, percentages, ratios, and proportions to practical situations.

REASONING ABILITY

Ability to solve practical problems and deal with a variety of variable in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand, walk, and talk or hear. The employee frequently is required to use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts and vibration. The employee is occasionally exposed to high, precarious places; fumes or airborne particles; toxic, flammable or caustic chemicals; outside weather conditions; and extreme heat. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Equal Opportunity Company Tekniplex is proud to be an Equal Opportunity Employer. Our hiring practices provide equal opportunity for employment without regard to race, religion, color, sex, gender, national origin, age, United States military veteran’s status, ancestry, sexual orientation, marital status, family structure, medical condition including genetic characteristics or information, veteran status, or mental or physical disability so long as the essential functions of the job can be performed with or without reasonable accommodation, or any other protected category under federal, state, or local law. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor. #J-18808-Ljbffr TekniPlex