Process Engineer

Process Engineer

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 together!

In 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:
  
  8:00 am - 4:30 pm M-F
• Location:
  
  Gibbstown, NJ (08027)
• Ideal Candidate:
  The ideal candidate will have a minimum of 3-5 years related experience in a manufacturing.
• Salary/Pay Range (based on experience and qualifications): $80,000+

Essential Job Functions:

• Develops a fundamental understanding of the processes and equipment. Utilizes technical and engineering tools to troubleshoot and understand the process.
• Support validation efforts for manufacturing processes, equipment, and systems, including commissioning and qualification activities and the development/execution of 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 teams and extended teams, providing technical engineering support from concept through implementation and start-up.
• 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 process and equipment design of new and existing manufacturing processes, including scale-up, technology transfer, process optimization, and commercialization activities.
• 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
• Review and approve process- and equipment-related technical documentation, including specifications, drawings, protocols, reports, and change controls.
• 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.
• 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 throughput.
• 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.
• Perform additional duties/tasks as needed or requested by management.

Qualifications:

• 3-5 years' experience in a process engineering role involved in the manufacture of FDA-regulated products.
• Knowledge of cGMP requirements and ISO standards.
• Experience supporting process improvements, equipment implementation, validation activities, and manufacturing start-up initiatives in a regulated environment.
• Experience developing and executing validation plans and procedures.
• Knowledge of IQ/OQ/PQ protocols.
• Knowledge of process-related standards.
• Familiarity with engineering drawings, process flow diagrams (PFDs), and related technical documentation.
• Strong mechanical aptitude.
• Strong problem-solving and troubleshooting skills.
• Ability to navigate ambiguous situations; flexible and adaptable.
• Collaborative attitude and strong interpersonal skills with the ability to communicate effectively and work cross-functionally at all levels, both internally and externally.
• Strong organizational and decision-making skills.
• Demonstrated project management skills with the ability to successfully manage multiple priorities simultaneously.
• Proven ability to perform under deadlines and adjust plans to meet changing business needs.
• Computer proficiency including Microsoft Office Suite, ERP systems, and related software.
• Self-starter with strong initiative, dependability, and the ability to work with minimal supervision.

Desired

Skills:

• Experience in a cGMP manufacturing environment.
• Lean Manufacturing and/or Six Sigma methodologies.
• Experience with batch manufacturing, process scale-up, and product commercialization.
• Familiarity with AutoCAD, Solid Works, or similar…