Engineering Compliance & CAPA Specialist

Samsung Biologics RKV; Rockville (MD); On-site; USD 93,000 - 124,000; Full time

Benefits offered by this job

13 paid holidays

Vacation time

401K match

Medical, dental, vision

Job summary

Samsung Biologics RKV is seeking an Engineering Services Compliance Specialist to support compliance across engineering operations, including CAPA, deviation management, and change control. The role emphasizes risk assessments, vendor support, and investigation activities to uphold regulatory excellence.

The candidate will collaborate with cross-functional teams, guide business owners on compliance processes, and contribute to continuous improvement and safety investigations for quality

Qualifications

• Bachelor’s degree in engineering or related field is required.
• 3–5 years of industry-related experience (CAPA management, deviation handling, change controls).
• At least 4 years in a pharmaceutical or FDA-regulated environment with technical writing experience.

Responsibilities

• Oversee change control, CAPA, and deviation management processes.
• Conduct work risk assessments to ensure regulatory and company compliance.
• Provide guidance to business owners on compliance requirements and processes.
• Support the Vendor Management process.
• Participate in safety and quality investigations with root cause analysis and corrective actions.
• Ensure efficient handling of administrative and compliance tasks.

Skills

Organizational skills

Problem solving

Leadership

Teamwork

Interpersonal skills

Education

Bachelor's degree in engineering or related field

Tools

Microsoft Word

Microsoft Excel

Microsoft Project

Job description

Samsung Biologics RKV is seeking an Engineering Services Compliance Specialist to support compliance across engineering operations, including CAPA, deviation management, and change control. The role emphasizes risk assessments, vendor support, and investigation activities to uphold regulatory excellence.

The candidate will collaborate with cross-functional teams, guide business owners on compliance processes, and contribute to continuous improvement and safety investigations for quality