Title:  Process Engineer, Operations

Job Summary

This fully onsite role is key to implementing new technology, developing, and introducing process improvements, standards, life cycle management, validation, supporting capital investments, and contributing to addressing complex assignments in select process areas, helping to advance and transform West's growing business. This person will have the opportunity to drive the implementation of new innovative processes and technologies in cooperation with the Operations, Quality and other plant teams.

Essential Duties and Responsibilities

• Actively participate and comply with all West HSE programs and regulations.
• Participates in the development of standard process elements and their continuous improvement.
• Responsible for proposing, evaluating, and implementing process improvement projects related to quality, service, and HSE, using best practice methodologies.
• Participates in global and regional SME teams and harmonization projects and coordinates related activities locally.
• Evaluates and analyzes historical data; prepares reports and trend analyses on production process performance in cooperation with QA/QC.
• Directly involved in the introduction of new products and technological methods.
• Develops and implements practices and procedures to improve and standardize production processes to ensure profitability, quality, and safety.
• Evaluates and recommends internal and external best practices to keep production processes at the leading edge.
• Manages and implements the best practice validation concept related to process areas and projects, in alignment with West’s global validation approach.
• Performs all duties in accordance with the company’s health and safety policies, environmental protection requirements, applicable legislation, and company policies.
• Maintain a neat and orderly work environment in accordance with West 5S program.
• Performs other duties as assigned based on business needs as directed.

Education

Bachelor's Degree in an Engineering field required

Work Experience

• Minimum 1-3 years experience within injection or compression molding related field preferred
• Manufacturing process troubleshooting preferred
• Manufacturing in a cGMP/Pharmaceutical manufacturing environment preferred
• Project management, ability to work independently required

Preferred Knowledge, Skills and Abilities

• 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.
• Experience working with ISO9001/13458, FDA and cGMP required.
• Understanding and experience in use of Lean manufacturing principles.
• 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 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.