Process Engineer Job Descriptions, Average Salary, Interview Questions

The Process Engineer supports manufacturing operations with scientific expertise to ensure the successful transfer of new products from development to manufacturing ensuring robust manufacturing processes at commercialization, failure investigation of commercialized products, and support processes to ensure performance within expected parameters. Includes laboratory roles.

In this role, you will have the opportunity to:

• Monitors and improves Manufacturing KPI – Overall Equipment Efficiency, Throughput, and Unplanned Stops during shift operation by supporting daily execution of Standard Works – Centerlines, Cleaning, Inspection, Start-ups and Shutdowns, and Changeovers
• Supports problem solving using continuous improvement tools – RCAs, fishbone, and 5S
• Assists in the development of technical and operating standards – Standard Operating Procedures, One Point Lessons, Job-Aides, and Troubleshooting Guides and training of manufacturing Associates
• Co-creates validation documents (IQ, OQ, & PQ) and leads the execution of process qualifications for new and existing production systems
• Follows and observes all regulatory requirements (GMPs, ISO, FDA, OSHA, internal policies) applicable to the area of responsibility

The essential requirements of the job include:

• Bachelor’s degree in Engineering or a related discipline; or equivalent combination of education and experience to perform at this level. A minimum of 2+ years overall related engineering experience within the medical device or a regulated industry
• Ability to work off-shift
• Professional Certification – Lean Six Sigma Green Belt or on track to getting certified within 12 months of hire
• Proficient with Manufacturing software – Minitab and Microsoft Applications – MS-Visio, MS-Power BI, MS-Excel, MS-Word, MS-PowerPoint
• Familiarity with real-time multiplex PCR and/or working under cGMP, ISO, and FDA regulations

Position summary:

The Process Engineer will be responsible for building and maintaining a strong and long-lasting culture of continuous improvement. This person will deliver continuous improvement training and actions throughout the facility while serving as the Subject Matter Expert on Continuous Improvement. They will provide direction to, Production Team Members, Engineers, and Functional Leaders throughout the facility. This individual will lead and grow a culture of Continuous Improvement and Change Management with all activities in the plant. The Process Engineer will facilitate continuous improvement projects focused on Team Members, food safety, quality improvements, on-time delivery, inventory and cost reductions, and process performance improvements. They will provide efficient leadership and cost-effective integration of Continuous Improvement, creating operational excellence.

Duties & responsibilities:

• Responsible for leading daily mini-Kaizen events for OEE improvements and longer detailed Kaizen or Process improvement events
• Evaluate process and/or requirement applications and recommend and implement improvements to the existing product, equipment, or processes
• Utilize Continuous Improvement tools, including but not limited to Early Management, Specialized Maintenance, Autonomous Maintenance, Failure Modes, and Effects Analysis, Induced Failure Testing, and support CI and Phase Progression efforts
• Provide engineering/technical support to day-to-day plant operations and maintenance
• Provide project management and technical support for capital projects
• Assist in the collection of data identifying opportunities and tracking improvements
• Experience applying formal Root Cause Analysis and problem-solving methodologies
• Utilizes the concepts of continuous improvement and cost reduction in the execution of the job function
• Follow and hold others accountable for following all company Good Manufacturing Practices
• All other duties as assigned

Workplace safety:

• Completes safety system documentation and verifies compliance with program standards. Reports deviations to Supervisor
• Participates in mandatory safety training and adheres to all safety policies
• Required to report all safety issues, near misses, and injuries

Quality & food safety:

• Completes quality & food safety system documentation and verifies compliance with program standards. Reports deviations to Supervisor
• Participates in mandatory food safety and quality training program requirements
• Preserves the integrity of the BRC system through adherence to the policies and procedures outlined. Takes actions necessary to resolve food safety and quality system deficiencies
• Required to report food safety and quality system failures and take actions necessary to preserve the BRC system

Position requirements:

• Bachelor’s degree in Chemical or Mechanical Engineering or equivalent experience
• A minimum of 2 years experience in an engineering process improvement position
• Proficient in the use of personal computers and Microsoft programs (Excel, Word, PowerPoint)
• Experience in the optimization of processes, including the establishment of process KPIs
• Ability to work collaboratively across organizational boundaries to achieve company results.
• Adaptable/Flexible: Functions effectively within ever-changing environments. Easily adjusts to multiple demands, shifting work priorities, ambiguity, adversity, and change. Is resilient, positive, and calm under pressure
• Drives Innovation and Growth: Thinks “outside the box”, encourages risk-taking, generates creative solutions, and learns from both successes and failures

Preferred qualifications:

• Have or working towards Six Sigma Green Belt or Black Belt certification preferred
• 2-5 years experience in a food/beverage, chemical/powder, or pharma manufacturing facility preferred
• Knowledge of process systems in a DCS environment
• Proficient in AutoCad
• Ability to read, understand, and update P&IDs

Innovate, optimize and troubleshoot new product introduction and commercial manufacturing processes throughout the lifecycle to improve process/product robustness, reduce cost, and eliminate waste in oral solid dosage manufacturing of modified release products using conventional and novel technologies. Design, develop, and optimize process simulation techniques for process optimization and scale-up.

Essential areas of responsibility

• Providing process engineering expertise for technology transfer, from pre-validation through commercial lifecycle for modified release solid oral dosage form manufacturing including scale-up, validation, and lifecycle changes
• Perform technical analysis to understand and reduce technology transfer risk, estimate cycle time, improve equipment fit, and implement required technologies
• Provide continued technical leadership to commercial operations and ensure cost-effective and robust manufacturing processes for various unit operations including blending, sizing, compression, coating, fluid bed processing, and novel technologies
• Contributing to business teams through innovation, strategic input, and industry knowledge to troubleshoot and achieve cost leadership
• Perform engineering analysis of process execution, recommends opportunities for improvement with plant efficiency and risk mitigation as goals, and capture analysis in campaign summary documents
• Provide process expertise in post-batch record review and analysis
• Act as a quality events investigator for assigned projects.
• Lead documentation for equipment, lead FMEAs, recommend equipment modifications as needed for validation optimization, Analyze statistical data from qualification, product, or functional specifications to determine conformance with standards and established quality requirements
• Maintain product during lifecycle (stage 3 – CPV) using appropriate statistical tools
• Implement and lead the use of new pharmaceutical manufacturing technologies including melt extrusion, spray drying, extrusion–spheronization, spray congealing, laser drills, nano particulates, continuous manufacturing, NIR, PAT, etc.
• Lead and execute material changes, process changes, cost reduction projects, and CPV
• Responsible for completing all training requirements and maintaining 100% compliance with all assignments
• Responsible to comply with company goals based on departmental assigned goals
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMPs), and Standard Operating Procedures (SOPs) instructions
• Responsible for performing additional related duties as assigned

Education/certification/experience

• A Master’s or Ph.D. degree in Chemistry, Pharmaceutical Engineering, Pharmaceutical Manufacturing, or Pharmaceutical Technology is required
• Proficiency with statistics (using JMP or Minitab), SPC, NIR
• Experience and certification in the commercialization of PAT or certification in project management
• Experience using Excel for data mining and analysis is required
• Experience with novel manufacturing technologies (at least two) melt extrusion, extrusion spheronization, spray drying, spray congealing, laser drills, nano particulates, continuous manufacturing, NIR, or PAT
• Masters – minimum 7 years experience; out of which at least three years in modified release oral solids manufacturing
• Ph.D. – minimum research work in any of the novel manufacturing technologies mentioned above and exposure to pharmaceutical manufacturing

Skills/knowledge/abilities

• Excellent verbal, written, and interpersonal skills required
• Understanding of various unit operations used in conventional and novel oral solid dosage manufacturing
• Comply with FDA regulations at all times
• Skill levels in MS Office including proficiency in Word, PowerPoint, Excel, and SharePoint
• Must be able to maintain the highest levels of confidentiality, integrity, and discretion

Problem solving

• Able to identify solutions to general problems through collaboration and creativity
• Proactively works on problems of complex scope
• Seeks out all resources when selecting methods and techniques for obtaining results
• Acts independently and proactively to recommend and administer methods and procedures for problem resolution

Working environment

• Fast-paced environment
• Able to manage multiple priorities and ensure appropriate follow-ups
• Highly organized and excellent time and project management skills with the ability to juggle a wide range
• Ability to work under pressure and meet deadlines
• Low to loud noise level exposure
• 24/7 Support based on business needs