Title:  Assoc, Process Eng, Sterilization

Job Summary

This role is key to developing and introducing process improvements, standards, life cycle management and validation in select process areas, helping to advance and transform West’s growing business, supporting capital investments and contributing to addressing complex assignments. This person has decision rights for his process area, and he/she will have the opportunity to drive the implementation of new innovative processes and technologies in cooperation with the engineering and quality assurance teams and the plants.

Essential Duties and Responsibilities

• The process area in focus is Sterilization (steam & gamma irradiation)
• Initiate, lead and coordinate continuous process improvement projects on quality, service, HSE and cost using the knowledge and best practices, even if this is outside the standard known/approved process frame.
• Initiate and maintain appropriate communication with departments in order to support good relations and maximize achievements through a cooperative environment
• Provide engineering support for day-to-day production activities. 
• Perform validations of sterilization and support equipment as required for initial implementation and recurring re-validations. 
• Track and trend process data to identify opportunities for improvement and to maintain expected process performance.
• Work with Global Process Engineering teams to implement best practices and technology improvements.
• Support product, process or technology transfer projects between plants from a process stand-point as assigned.
• Engage in solutioning product or process related issues as needed.
• Ensure that all projects and activities are in compliance with local, regional and best practice requirements and meet other applicable authority requirements. All internal change control procedures incl. e.g. adequate risk assessment / FMEA are to be followed strictly
• Prepare reports as may be required on a routine basis or on demand within established deadlines.
• Lead process engineering projects within Sterilization process and other areas of site as assigned.
• Utilize six sigma tools in minimizing process variation and improving the quality of product produced.

Additional Responsibilities

Education

• Bachelor’s or Master degree in Biology/ Microbiology /Chemistry or another scientific area required

Work Experience

• Bachelor’s degree in Biology/ Microbiology /Chemistry/Engineering or another scientific area
• Previous steam/gamma sterilization experience required 
• 1-3+ year experience in a similar position within the manufacturing industry
• Good knowledge of LEAN and 6 sigma manufacturing principles
• cGMP knowledge
• Ability to assert technical solutions and standards
• Very good organizational and project management skills
• Excellent communication skills and ability to successfully collaborate with teams across different countries and organizational levels
• Highly analytical and structured way of working
• Self-motivated, results- and solution-oriented personality

Preferred Knowledge, Skills and Abilities

• General knowledge of OSHA/EPA/safety regulations, manufacturing, and process automation.
• Maintain an awareness of “state of the art” technology as it applies to our industry. Take part in educational programs pertinent to process projects.
• Working knowledge of business and shop floor systems to effectively manage operations; prefer SAP and MS Office applications.
• Experience working with ISO9000, FDA and cGMP preferred 
• Understanding and experience in use of Lean manufacturing principles preferred 
• Ability to write routine reports, correspondence, and process documents.
• Excellent organizational and communication skills.
• Works independently with minimal guidance.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times

License and Certifications

• Manufacturing\Six Sigma Green Belt Certification preferred

Travel Requirements

Physical Requirements

Additional Requirements

• 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 ability to be able to lift and carry various items up to 40 pounds.
• 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 employee occasionally works in clean room environments requiring special gowning and training to operate in these environments.
• 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 (sometimes quick), interpreting data, reading, or writing, organization, problem solving, understand direction, etc.

#LI-TH1