Position Details:- Title: Process Engineer
- 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, 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.
