Process EngineerJob Description, Salary, Career Path, and Trends
A process engineer designs, oversees, assesses, and implements processes that efficiently make products or provide services. The goal of a process engineer is to create systems that make the best use of workers, machines, materials, information, and energy. Process engineers design processes for use in a wide array of industries, including manufacturing, pharmaceutical, petroleum, and biotechnology. They review production schedules, design specifications, workflows, and other information to understand and adjust their company’s processes to make them more efficient.
Because workers are an essential part of many of the systems a process engineer designs, high-level interpersonal communication skills are vital in this role, in addition to skills and experience in engineering. Planning and analytical thinking are also a crucial part of being a process engineer. This position combines skill sets from several different jobs, including supply chain management, project management, and quality assurance.
Sample job description #1
The Process Engineer supports manufacturing operations with scientific expertise to ensure successful transfer of new products from development to manufacturing ensuring robust manufacturing processes at commercialization, failure investigation of commercialized products, support processes to ensure performance within expected parameters. Includes laboratory roles.
This position is part of the Automated Packaging operations team and will be located in (City, State).
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 supports 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 execution of process qualifications for new and existing production systems
Follows and observes all regulatory requirements (GMP’s, 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 medical device or a regulated industry
Ability to work off-shift
The essential requirements of the job include:
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
Sample job description #2
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 Member, food safety, quality improvements, on-time delivering, 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 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 for 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
Completes safety system documentation and verifies compliance to program standards. Reports deviations to Supervisor
Participates in mandatory safety trainings 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 to 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
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, Power Point)
Experience in optimization of processes, including establishment of process KPI’s
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
Have or working towards Six Sigma Green Belt or Black Belt certification preferred
2-5 years experience in a food/beverage, chemical/powder, pharma manufacturing facility preferred
Knowledge of process systems in a DCS environment
Proficient in AutoCad
Ability to read, understand, and update P&ID’s
Sample job description #3
Innovate, optimize and troubleshoot new product introduction and commercial manufacturing processes throughout 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
All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.
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 trouble shoot and achieve cost leadership
Perform engineering analysis of process execution, recommends opportunities for improvement with plant efficiency and risk mitigation as goals, and captures 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 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 (cGMP’s), and Standard Operating Procedures (SOP’s) instructions
Responsible for performing additional related duties as assigned
A Masters or PhD 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 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 spherization, 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
PhD – minimum research work in any of novel manufacturing technologies mentioned above and exposure to pharmaceutical manufacturing
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
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
Sitting for extended periods of time at work station or mobile equipment
Using fingers to perform activities such as picking, pinching, or typing
Repetitive Motions (frequent motions of the wrists, hands, and/or fingers)
Walking to move short distances quickly and frequently
Standing for extended periods of time at work station or equipment
Close visual acuity to perform activities such as computer work, preparing and analyzing data, extensive reading, visual inspection involving small defects, small parts and/or operation of machines (including inspection), using measurement devices, and/or assembly or fabrication of parts at a distance close to the eyes
Visual acuity to perform activities such as operating machines (i.e. lathes and drill presses) where the seeing job is at or within arm’s reach
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
Average salary and compensation
The average salary for a process engineer is $89,200 in the United States. Position salary will vary based on experience, education, company size, industry, and market.
Los Angeles, California
Minneapolis-St. Paul, Minnesota
New York City, New York
Sample interview questions
What is a process engineer to you?
How do you plan and prioritize your work?
What skills do process engineers need to be successful?
What techniques do you use to troubleshoot existing production processes?
What are the steps of designing new production processes?
What major processing systems have you implemented?
How would you troubleshoot a piece of equipment in a plant?
What is a P&ID? Have you used one before?
How familiar are you with composing instructional documents, blueprints, and troubleshooting guides for processing systems?
How do you handle pressure at work?
Can you describe a situation when you went above and beyond with your service?
What do you want to accomplish in this position with our company?
What is your biggest professional failure? What did you learn from it?
What was your most successful engineering experience?
What motivates you at work?
Can you describe a problem you were unable to solve? How did you resolve the issue?
Can you describe a time when you inspected materials, components, and products for defects?
What interests you in this role?
How do you prioritize your work?
How would you work with a high volume of data that involves many different overlapping processes?
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