Process EngineerGrand Haven, MI
The Process Engineer will provide both the long-term and the day-to-day process engineering support of the plant. This role is responsible for optimizing manufacturing processes to provide sustainable gains in cost effectiveness and product performance through capital projects, statistical analysis, designed experiments, and procedural changes
Essential Duties and Responsibilities
- Develop, plan and execute capital projects including developing business case (IRR/ROI), creating detailed project plan, interfacing with external vendors and suppliers and managing the implementation of the project to the schedule and budget.
- Design, install, and commission new production units, monitor modifications and upgrades, and troubleshoot existing processes.
- Improve the quality, efficiency, yield output and safety and reduce manufacturing costs through improved processes and designs
- Make observations and take measurements directly, as well as collect and interpret existing data from other sources, such as data historian, batch records, equipment logs, and technical and operating staff.
- Assist with conceptual and detailed design of new equipment or processes as appropriate.
- Conduct design reviews.
- Prepare reports, flow diagrams and charts as necessary to justify process improvements.
- Assess environmental impact of operations within the plant.
- Manage the cost and time constraints of projects.
- Select, manage, and work with contractors.
- Support the conversion of pilot-scale processes into commercially viable large-scale operations.
- Participate in risk assessments, including hazard and operability (HAZOP) and Process Failure Mode and Effects Analysis (PFMEA).
- Update and write SOP’s, batch records, checklists, etc. as necessary and train employees as necessary.
- Prepare and complete process validation protocols and reports. Lead site personnel in the investigation of validation deviations.
- Create, review and approve change control documents for new or modified equipment, batch records, production SOP’s, and maintenance SOP’s.
- Assist in cGMP audits, Quality System audits, and Safety System audits.
- Act as a liaison with production employees to ensure user friendly batch records and standard operating procedures (SOPs) for new products. Drive recommendations for improvements.
- Assist with external audits, corrective actions customer complaints, process deviation investigations, and toll manufacturer quality programs, as needed.
- Perform other duties, as assigned.
Education and/or experience
- Bachelor of Science Degree in Engineering (Chemical or Mechanical preferred)
- 10+ years demonstrated process engineering experience within the pharmaceutical, food or chemical industry
- Demonstrated ability to conduct problem solving activities using tools such as DMAIC, DOE, Regression Analysis, SPC, FMEA
- 6 Sigma Green/Black Belt preferred
- Statistical software experience (Minitap, JMP, DOE, StatEase)
- Hands-on experience working with powder process equipment, such as: milling, screening, powder transfer and spray drying
- Understanding of chemical engineering and chemistry principles and how to apply
- Exhibits strong process & equipment design skills
- Demonstrated history of successful project management
- Ability to write standard operating procedures (SOPs), batch records, checklists, etc.
- In-depth experience with cGMP or ISO quality standards
- Excellent verbal and written communication skills
- Self-starter with strong leadership, collaboration, analytical and problem-solving skills
- Ability to read mechanical drawings/prints
- CAD experience, a plus
- Proficient in Microsoft Word and advanced Excel skills
- Ability to frequently lift up to 25 lbs and occasionally up to 50 lbs
If you are looking for a Company that is:
- Employee centric
- Driving innovation in the Pharmaceutical Industry
- Focused on long term sustainable growth
Then apply to join our team!