Title:  Process Improvement Eng

Job Summary

The Process Engineer will function as a member of the process excellence team to deliver and implement solutions for the safe and efficient operation/improvement of the facility, equipment, and processes.  This position will support design, development, and validation requirements for existing/new equipment, technical reporting as well as cost savings/lean initiatives.  This role will use of Lean Sigma and root cause analysis tools.

Essential Duties and Responsibilities

• Support the implementation, development, transfer and improvements of processes and products within the facility related to extrusion, molding, trimming, B2 coating, and clean room production.
• Interact with engineering, management, site, and corporate team members, and/or vendors to develop engineering controls or required process improvements.
• Plan, guide, coordinate or perform modifications, improvements, or new initiatives for new or existing products or processes.
• Plan, coordinate, or perform projects assigned to the approved schedules and budgetary commitments.
• Support and recommend new and experimental product development activities related to extrusion, molding, trimming, B2 coating, and clean room production.
• Ensure all changes are appropriately documented through engineering studies, change controls or other methods of documenting change.
• Support projects and initiatives stemming from the Global Process Engineering Team.
• Research and analyze data to determine optimal processing conditions.
• Contributes to continuous process improvement efforts.
• Use statistical methods and good documentation skills to ensure evaluation is completed with the necessary information.
• Initiate, support and execute process related CAPAs for Quality Initiatives or Complaints.
• Must have good communication skills while working with operators, engineers, and management.

Additional Responsibilities

Education

• Bachelor's Degree Engineering required

Work Experience

• Minimum of 3-5 years equivalent experience in cGMP/Pharmaceutical manufacturing environment manufacturing.
• AutoCAD and/or SolidWorks, or related systems, experience preferred
• Six Sigma and Lean Manufacturing experience preferred

Preferred Knowledge, Skills and Abilities

• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times
• General knowledge of OSHA/EPA/safety regulations, manufacturing, and process automation.
• Working knowledge of business and shop floor systems to effectively manage operations; prefer SAP and MS Office applications.
• Knowledge of facilities design/maintenance.
• Experience working with ISO9000, FDA and cGMP required.
• Understanding and experience in use of Lean manufacturing principles.
• Ability to read and interpret documents and drawings, specifications, safety rules, operating instructions, procedure manuals and regulatory documentation.
• Ability to write routine reports, correspondence, and process documents.
• Write monthly progress reports and capital requests.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description

License and Certifications

Travel Requirements

Physical Requirements

Additional Requirements

• Medium – exerting up to 50lb/22kg of force occasionally and/or up to 20lbs/9kg of force frequently, and/or up to 10lbs/4kgs of force constantly to move objects
• While performing the duties of this job, the employee is regularly required to, sit, stand, walk, talk, hear, see and use hands and fingers to operate office equipment (ie phones, computers, copies, etc.).
• Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites.
• The employee is occasionally exposed to wet and/or humid conditions and fumes or airborne particles.
• The employee occasionally works near moving mechanical parts and or equipment.
• The noise level in the office work environment is usually quiet.  The noise level in the manufacturing work environment is moderate to loud.  Hearing protection is required as posted in the manufacturing work environment.
• Job requires mental skill or ability such as communication, decision making, interpreting data, reading, or writing, organization, problem solving, understand direction, and speak publicly