Production Engineer I - GMP/QA Focus (Hybrid)

Getinge; Wayne (NJ); Hybrid; USD 88,000 - 92,000; Full time

Benefits offered by this job

Health insurance

401k with company match

Paid Time Off

Wellness initiative & Health Resources

Life Insurance

Disability benefits

Flexible Spending Accounts

Commuter Benefits

Parental and Caregiver Leave

Tuition Reimbursement

Job summary

Getinge is seeking an Engineer I, Production in Wayne, NJ, to review production documentation, validate processes, and drive improvement projects. The role supports compliance with regulatory standards and quality systems while collaborating with manufacturing engineering leadership.

Ideal candidates hold a BS in engineering with up to 2 years of related experience, familiar with GMP/FDA/ISO, and able to contribute to validation activities and CAPA efforts in a hybrid workplace.

Qualifications

• Bachelor’s degree in engineering; 0–2 years of related experience.
• GMP/FDA/ISO understanding preferred.
• Experience in a regulated environment preferred.
• Windchill experience a plus.
• Process validations/qualifications and statistics training/experience a plus.

Responsibilities

• Review production documentation and address deficiencies.
• Write and execute validation protocols; analyze protocol data.
• Review procedures and implement changes as needed.
• Ensure compliance with Quality System Procedures, GLP, and exposure controls.
• Support compliance with FDA MDR EUMDR and related regulations.
• Assess and implement corrective/preventative actions and calibration issues.
• This role is hybrid; some days in office in Wayne, NJ.

Skills

Technical ability

Analytical thinking

Communication

Organizational skills

MS Excel

Statistical analysis

Project management

Education

Bachelor’s degree in Biomedical/Mechanical/Manufacturing Engineering or equivalent

Tools

Windchill

Job description

Getinge is seeking an Engineer I, Production in Wayne, NJ, to review production documentation, validate processes, and drive improvement projects. The role supports compliance with regulatory standards and quality systems while collaborating with manufacturing engineering leadership.

Ideal candidates hold a BS in engineering with up to 2 years of related experience, familiar with GMP/FDA/ISO, and able to contribute to validation activities and CAPA efforts in a hybrid workplace.