Process Engineer

Keystone Industries; Gibbstown (NJ); On-site; USD 72,000 - 88,000; Full time

Job summary

Keystone Industries is seeking a Process Engineer in Gibbstown, NJ to develop and optimize manufacturing processes for FDA-regulated products. You will support validation activities, write CAPAs and change controls, and collaborate with QA, production, engineering, analytical, and R&D teams to ensure quality and efficient production.

Ideal candidates have 3-5 years of process engineering experience, knowledge of cGMP and ISO standards, and proficiency with validation plans and equipment

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.

Responsibilities

• Develops a fundamental understanding of the processes and equipment; troubleshoot and understand the process.
• Support validation efforts for manufacturing processes, equipment, and systems, including IQ/OQ/PQ protocols.
• Write CAPAs, NCRs, process deviations, and other quality documentation for regulated production.
• Manage projects and participate in project core teams from concept through start-up.
• Interface with quality control, quality assurance, production, engineering, analytical and R&D personnel.
• Lead root cause analysis and corrective actions to reduce cost of poor quality.
• Assist in prioritizing maintenance and operational activities to maintain production schedules.

Skills

3-5 years process engineering

cGMP knowledge

problem-solving

communication

Education

BS in Chemical Engineering

Tools

AutoCAD

SolidWorks

ERP systems

Microsoft Office

D365

Job description

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 ouremployees the resources to pursue their goals, both at work and in their personal lives.

Please visit our website atwww.keystoneind.com to learn more about Keystone Industries and career opportunities.

• Title:Process Engineer
• 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, SolidWorks, or similar engineering software.
• Microsoft D365.

Education/Certifications:

• Bachelor of Science in Chemical Engineering or related discipline.

Safety:

• Comply with all safety regulations; maintains a safe work environment at all times.
• Adhere to always wearing the proper PPE/Safety equipment.
• Understand and comply with all written safety, health, and environmental procedures.
• Attend all required scheduled Health, Safety and Environmental training sessions.
• Participate in required Health, Safety and Environmental initiatives and programs.
• Perform required administrative functions related to Health, Safety and Environmental functions such as completing forms, checklists, and log sheets.

Physical Demands and Work Environment:

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Physical Demands: Employee is required to walk; stand; sit; use hands and fingers to manipulate objects, tools, or controls; reach with hands and arms; balance; stoop; bend; kneel and climb; and occasionally lift/move up to 50 lbs. In addition, may seldomly be required to maneuver and move 30 to 55-gallon drums and up to 450 pounds utilizing proper ergonomic handling equipment and/or the proper techniques.
• Work Environment: This position is located in a manufacturing facility. Employees frequently work near moving mechanical equipment. Noise intensity level: moderate to loud. Employees may work with hazardous contaminants. This role requires one to work both in an office and manufacturing environment; certain job functions may need to be performed in a cleanroom environment. Employees must adhere to all Personal Protective Equipment (PPE) and gowning requirements.

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.