Responsible for providing process engineering support for the day to day operations of the Clean & Pack Business Unit. Engineering services include Process Development, Process Validation, tool and fixture design, and capacity expansion. The candidate for this role needs to display knowledge of Clean and Pack operations, have strong process validation and project management experience, to deliver engineering actions on time and within budget.

Principal Duties & Responsibilities

•Validation assessment and validation execution of Final Cleaning, Biological Upgrade and Packaging processes.
•Establishing process methods which meet performance and quality requirements.
•Review and assess in house Clean and Pack processes to determine improvements.
•Sorting through options choosing the most appropriate solutions.
•Developing a wide a variety of applications, clean and packaging.
•Developing project plans and schedules for work activities.
•Conducting feasibility study to estimate product cost and analyze capital equipment, capacity, and capability requirements affecting the make versus buy decision

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA

• Skilled in writing and execution of Validation protocols, IQ/OQ/PQ.
• B.Sc. in Mechanical, Industrial Engineering, or other Engineering Science and/or demonstrated multiple years of Validation experience.
• Skilled and knowledgeable in Clean and Packaging Operations and new product introductions.
• Familiarity with control procedures, such as the Change Notification and Deviation process, and Engineering Specifications.
• Familiarity with reviewing engineering drawings for geometric dimensioning and tolerancing.
• Demonstrates good problem solving skills through the use of quality and statistical tools.
• Ability to effectively work within a team and cross functionally to expedite completion of critical project tasks. 
• Demonstrates good written and verbal communication skills.
• Microsoft Office Suite and Project; Statistical Process Control skills;