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Process Engineer - Gibbstown, United States - Keystone Industries
Description
Company Overview:
We are passionate about our employees.
We strive to create an environment that is stimulating and motivating and a culture that fosters mutual respect, teamwork, and career development.
Come join the Keystone team so we can build your career togetherIn addition to competitive starting salaries, we offer a wide variety of competitive benefits, perks and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
Please visit our website at to learn more about Keystone Industries and career opportunities.Position Details:
Schedule: 8:30 am - 5:00 pm, M-F with flexibility.
*This position is 100% ONSITE in an manufacturing/office setting*Location: Gibbstown, NJ Position OverviewThe Process Engineer will be the technical resource providing support to new and existing manufacturing processes with the goal of ensuring safe, high-quality, FDA compliant processes and identifying opportunities for continuous improvement.
Essential FunctionsMonitors day-to-day quality and makes changes as necessary.Support validation efforts for manufacturing processes, equipment, and systems, including developing IQ, OQ & PQ protocols, compliant with existing SOPs.
In collaboration with other personnel, develop and write CAPAs, NCRs, process deviations, and other quality documentation to ensure quality and efficient production of regulated products.
Manage projects and participate in applicable project core team(s) and extended team(s) Interface regularly with quality control, quality assurance, production, engineering, analytical and R&D personnel Provide cross-functional support by sound and timely decision making utilizing statistical and problem-solving tools Contribute to the design for the manufacturing of new products.
Identifies, recommends, and implements process improvements Identify and specify the purchase of new equipment for process improvements Utilizes quality systems for validation of new equipment Lead root cause analysis and corrective actions to establish plans to reduce cost of poor quality.
Act as the point of contact for troubleshooting/problem solving of quality upsets.Develops a fundamental understanding of the processes and equipment. Utilizes technical and engineering tools to troubleshoot and understand the process.
Assists in prioritizing maintenance and operational activities to maintain production schedules.
Identifies scope of capital projects to improve safety, quality, reliability, and production.
Identify and support opportunities for manufacturing cost reductions.
Improves process throughput. Utilizes modeling tools to identify bottlenecks and proposes operational or equipment modifications to improve throughout.
Scale-up and first production of new products and processes. Key member of project teams to introduce new products into production and provide first samples to customers.
Routinely assesses process using measurements and data interpretation. Utilizes statistical tools to analyze process data to ensure process is in control and capable.
Support future Engineering and Quality initiatives.
Perform research as needed.
Other duties/tasks as needed/requested by Manager.
Qualifications3-5 years' experience in process engineering role, involved in the manufacture of FDA regulated products. Knowledge of cGMP requirements and ISO standardsExperience with developing and writing validation plans and procedures.
Knowledge of IQ/OQ/PQ protocols.
Knowledge of process related standards.
Strong Mechanical Aptitude.
Strong problem-solving and troubleshooting skills.
Ability to navigate ambiguous situations; flexible.
Collaborative attitude and strong interpersonal skills - ability to interface and communicate/collaborate at all levels internally and externally.
Strong organizational and decision-making skills.
Demonstrated Project management skills. Ability to successfully work on multiple projects simultaneously.
Computer proficiency including Microsoft Office Suite, Smartsheet, ERP systems, etc. Desired SkillsCleanroom experience. Prior QMS experience. Six Sigma Green Belt/Black Belt Lean Manufacturing Batch production and scale-up experience. Capital Project Management (
