Senior Process Engineer III - Manufacturing Excellence

Smith+Nephew; Columbia (MD); Hybrid; USD 97,000 - 145,000; Full time

Benefits offered by this job

401k Matching Program

Tuition Reimbursement

Paid Holidays

Paid Community Service Day

Job summary

Smith+Nephew in Maryland is seeking a Process Engineer 3 to drive continuous improvement, support new product introductions, and ensure manufacturing processes meet top standards. You will lead process improvements, manage change controls, and collaborate with multi-disciplinary teams to enable successful commercialization.

The role emphasizes experience in FDA-regulated environments, strong communication, and ability to navigate shifting priorities while delivering cost-saving opportunities and

Qualifications

• Bachelor's degree in Engineering or Life Sciences.
• 3+ years of manufacturing or process engineering experience within an FDA regulated environment.
• Proficient in MS Office software (Word, Excel, PowerPoint).
• Demonstrated ability to work in a professional, multi-disciplinary, multi-cultural team as a group leader, facilitator, or participant.
• Effective verbal and written communication skills.

Responsibilities

• Lead development and implementation of manufacturing process improvements and production controls.
• Drive risk assessments and gap assessments to strengthen processes.
• Oversee equipment and process qualifications to support regulatory requirements.
• Author, execute, and review change controls, validation protocols, CAPAs, and other quality docs.
• Support new product transfers from development into manufacturing.
• Qualify new manufacturing equipment and support validation activities.
• Partner with cross functional teams to identify cost saving opportunities.
• Develop user needs documentation and contribute to improvements.
• Conduct R&D activities to evaluate new ideas and technologies.

Skills

MS Office

Communication

Team leadership

Collaboration

Time management

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Smith+Nephew in Maryland is seeking a Process Engineer 3 to drive continuous improvement, support new product introductions, and ensure manufacturing processes meet top standards. You will lead process improvements, manage change controls, and collaborate with multi-disciplinary teams to enable successful commercialization.

The role emphasizes experience in FDA-regulated environments, strong communication, and ability to navigate shifting priorities while delivering cost-saving opportunities and