Process Engineer

West:By Your Sidefor Opportunity West Pharma; United States; On-site; USD 90,000 - 140,000; Full time

Job summary

West Pharmaceutical Services is seeking a Process Engineer to join the process excellence team. The role focuses on delivering and implementing safe, efficient manufacturing improvements across extrusion, molding, trimming and clean room production.

You will apply Lean Sigma, root cause analysis, and design validation support to optimize processes and reduce waste. Ideal candidates will have 3–5 years in a cGMP/pharma environment, a bachelor’s degree in engineering, and experience with

Qualifications

• Bachelor’s degree or equivalent experience; preferred in engineering.
• 3–5 years in a cGMP/pharmaceutical manufacturing environment.
• Experience with ISO9000, FDA and cGMP compliance.
• Lean manufacturing and Six Sigma experience preferred.
• Ability to read and interpret drawings, specifications, and regulatory docs.
• Strong communication and ability to work with operators and management.

Responsibilities

• Support extrusion, molding, trimming, and clean room production process improvements.
• Coordinate engineering controls and process improvements with cross-functional teams.
• Plan and manage projects within approved schedules and budgets.
• Document changes via engineering studies, change controls, and CAPAs.
• Perform data analysis to determine optimal processing conditions and drive continuous improvement.
• Ensure compliance with cGMPs, validation plans and regulatory initiatives.

Skills

Lean Six Sigma

Statistical analysis

Engineering docs

cGMP knowledge

Root cause analysis

Project management

Interpersonal comms

Reading drawings

Process optimization

Continuous improvement

Education

Bachelor’s Degree in Engineering

Tools

AutoCAD

SolidWorks

SAP

MS Office

Job description

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

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, 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 within the production environment.
• 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 to reduce scrap, cycle times, improve efficiency.
• Assume full responsibility for various engineering projects as assigned.
• Work with other engineers and departments to ensure successful evaluation of all new equipment process improvements.
• 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.
• Must be able to work with minimal supervision and work flexible hours.
• Adhere to all Company policies.
• Use good housekeeping practices to maintain a clean, orderly, and safe work area.
• Ensure compliance to cGMP’s, Validation Master Plans, FDA, and other regulatory agency initiatives.
• Other duties as assigned

Education

• Bachelor’s Degree or equivalent experience preferred

Work Experience

• Minimum of 3-5 years equivalent experience in cGMP/Pharmaceutical manufacturing environment manufacturing.

Preferred Knowledge, Skills and Abilities

• AutoCAD and/or SolidWorks, or related systems, experience preferred
• Six Sigma and Lean Manufacturing experience preferred
• 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.
• Excellent organizational and communication skills.
• Works independently with minimal guidance. May make decisions without checking in with manager.
• Ability to speak effectively before groups and employees in the organization.
• 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

Travel Requirements

10%: Up to 26 business days per year

Physical 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.

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 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

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening.