What Does a Process Engineer Do?
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 crucial parts of being a process engineer. This position combines skill sets from several different jobs, including supply chain management, project management, and quality assurance.
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National Average Salary
Process engineer salaries vary by experience, industry, organization size, and geography. To explore salary ranges by local market, please visit our sister site zengig.com.
The average U.S. salary for a Process Engineer is:
Process Engineer Job Descriptions
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
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
- 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
- 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
- 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
- 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
- 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
- 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
How to Hire a Process Engineer
Consider the following when hiring a process engineer:
- Recruiting: Do you have the internal resources and tools to source and recruit for this role successfully?
- Complexity: Do you need a senior professional, or will mid, or even junior-level skills suffice?
- Duration: Is this a one-time project, or an indefinite need?
- Management: Can you effectively direct the work effort?
- Urgency: Are there any deadlines associated with this need?
- Headcount: Do you have the budget and approval for an internal employee, or should you consider alternate options?
Answering these questions will help determine the best course of action for your current hiring need. Fortunately, various great options exist for every scenario, no matter how unique. When hiring a process engineer, we recommend the following options:
1. Use 4 Corner Resources (or another professional recruiting firm)
The heavy lifting is done for you when working with a top-tier staffing company like 4 Corner Resources. We source, screen, recruit, and deliver only the most qualified candidate(s), saving you significant time and effort throughout the hiring process while you remain focused on your core business. Understanding your needs and ensuring the right candidate for the position is the key to our success.
This is the best route to take when:
- You need to fill the position quickly
- You want access to a vast talent pool of high-quality, prescreened candidates
- Your position is suited for temporary hiring services, contract staffing, or contract-to-hire recruiting, and you intend to direct the work activity.
- You are hiring an employee as a direct placement but aren’t able to recruit effectively or efficiently with your internal staff.
- You aren’t familiar with current salary rates, market trends, and available skill sets
2. Advertise your opening on a top job board
Your best option may be to advertise your opening on a proven job board. There are many widely used job sites out there that draw visits from qualified candidates. If you have someone internally who can dedicate the time and energy to sort through applications and screen individuals effectively, this can be a great choice.
We recommend using a job board when:
- Your internal recruiting team has the knowledge and experience to assess candidate qualifications
- You are hiring a direct employee and have time to manage the entire recruiting effort
- You have a process for receiving, screening, and tracking all resumes and applications
- You are prepared to respond to all applicants
There are many career sites out there. Here are the two we recommend for a process engineer opening:
LinkedIn is a social network for job seekers, professionals, and businesses. With this popular job site, you can enhance your brand and advertise your open position to a wide audience of motivated, qualified candidates. Job postings on LinkedIn are also extremely streamlined and user-friendly, making it even easier for candidates to apply. Additionally, applicants can use their LinkedIn profile instead of a resume to expedite the process.
CareerBuilder has been a trusted source for hiring since 1995. Reach 80+ million unique, diverse U.S. job seekers annually by posting your jobs through their talent acquisition channels. Through CareerBuilder, you can engage candidates and drive them into your sourcing pipeline. We recommend using CareerBuilder for hiring when you have the internal resources and processes to review, screen, and reply to all applicants.
3. Leverage your internal resources
You can utilize your own website, social media, and employees to assist in your search for top candidates.
A company website posting should be the first step in notifying prospective candidates that you are hiring. Social media can also be a powerful tool for spreading the word about your new opening. As far as exposure is concerned, this option can be as good as some job boards when you have a large enough following across various platforms, like LinkedIn, Instagram, Facebook, TikTok, and Twitter.
Current employees are every organization’s greatest asset. Encourage your internal team to promote job openings to their network by offering cash and other incentives.
We recommend these options when:
- Your brand has great name recognition
- You can consistently monitor and respond to candidate activity through your website and social media accounts
- You have a process in place to quickly and broadly communicate job openings and requirements
- You have an effective employee referral program in place
If you aren’t sure which path is best, schedule a discovery call today with our seasoned recruiting professionals. The 4 Corner team is on standby to help you find the best option for your unique hiring need.
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 for 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?