Process Engineering Manager

Job Location US-KS-McPherson
ID
2018-3982
# of Openings
1
Category
Engineering
Type
Direct Hire

Overview

The Process Engineering Manager’s goal is to provide process engineering and product ownership to the site in an effort to satisfy the site Growth Strategy in addition to strategy deployment associated with Safety, Quality, and Continuous Improvement (CiP) program initiatives. 

Responsibilities

  • Serve as a technical lead/product owner for manufacturing process development and continuous improvement activities associated with quality, yield, waste, cycle time, safety, and process robustness across a portfolio of consumer healthcare products in the OTC and oral care categories.
  • Propose and implement process improvements, monitor process capability, and conduct product performance assessments using statistical analysis to support the Product Lifecycle Management program.
  • Conduct investigations of process deviations to determine root cause/corrective actions
  • Perform technical risk assessments and develop product control strategies for assigned products
  • Author and execute plant trials to resolve process challenges as well as implement new improvements.
  • Author/revise Batch Records, SOPs, technical reports, technical change controls, and other site documentation
  • Conduct technical training on processes and procedures to all levels of the organization
  • Collaborate with R&D to ensure Design for Manufacturing principles are used for optimization of new product/technology introduction
  • Support both internal and external manufacturing associated with new product introduction and technology transfer programs
  • Support site functions (i.e. Engineering, EHS, Operations, etc.) with technical expertise including process validation initiatives, engineering capital projects, etc.
  • Provide support to site process safety program
  • Provide technical, directional, developmental and motivational leadership for a group of process engineers.
  • Responsible for solid oral dosage equipment performance improvement and troubleshooting.
  • Overall responsibility for managing the execution of risk analysis, equipment and associated document changes, training, investigations, corrective actions and proactive improvements resulting in improved equipment uptime and performance.
  • Lead the definition of user requirements.
  • Partner with manufacturing, engineering, validation, maintenance, technical services and quality to ensure commissioning qualification and validation activities are successfully completed on time and meet the highest quality standards.
  • Partner with maintenance to develop and improve preventative maintenance to develop and improve preventative maintenance procedures.
  • Ensure compliance with cGMPs and safety standards.
  • Provide a high level of service to manufacturing while anticipating the needs of the business.
  • Lead and/or participate in the development and implementation of business processes, procedures, policies and strategies aimed at improving performance and compliance.
  • Provide clear, concise reporting of the group’s objectives, strategies, plans and performance.
  • Lead a group of employees or outside contractors/vendors who have similar technical or functional responsibilities.
  • Develop staff capabilities, including both technical and soft skills.
  • Assign tasks, review work, and write and deliver performance appraisals.
  • Foster collaborative cross functional relationships focused on issue resolution and improved equipment/process/operation performance.
  • Provide technical leadership for equipment troubleshooting to the manufacturing team, including during off-hours.
  • Partner with maintenance to develop and improve preventative maintenance procedures.
  • Ensure all work undertaken is performed in accordance with standards and expectations according to company standards and industry regulations.
  • Have a strong operating knowledge of solid oral dosage unit operations.
  • Ensure assigned projects are on schedule and within budget.
  • Provide engineering expertise for continuous improvement of operator performance, operating efficiency, and product quality and safety.
  • Serve as peer-recognized technical expert for the manufacturing area.
  • Lead/perform process risk assessments.
  • Participate in the investigation of deviations: scope, product impact, root cause and corrective action identification.
  • Own and author deviations.
  • Own and implement Corrective Actions/Preventative Actions.
  • Lead and participate in the implementation of Change Control records.
  • Participate in regulatory inspections.
  • Participate in the development and/or revisions of procedures.
  • Participate in the commissioning, qualification and validation of equipment and processes.

Qualifications

  • Bachelor’s in Chemical or Mechanical Engineering
  • A minimum of 8 years of experience in process engineering in a pharmaceutical or similar manufacturing environment
  • Experience in process development, experimental design/statistical analysis, process optimization, and scale-up
  • Ability to lead cross-functional teams
  • Ability to lead and direct complex or novel assignments
  • Experience in new product introduction, technology transfer, and process/equipment validation
  • Working knowledge of various manufacturing processes and unit operations including: powder/material handling and dispensing, roll compaction, dry blending/milling, tablet compression, and secondary packaging
  • Basic knowledge of process automation/control systems
  • Continuous improvement background with knowledge of Lean Manufacturing/Six Sigma/OE tools and techniques
  • Understanding and application of Quality by Design (QbD) principles and process analytical technology (PAT)

 

Preferred Qualifications

 

  • Master’s in Engineering preferred
  • Experience using coaching/mentoring techniques and interpersonal communication skills in working with a diverse population at all levels of the company (i.e. shop floor to global corporate partners)
  • Competency in technical writing
  • Leading multiple projects simultaneously with minimal direction

 #CB

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