Pharma Engineering Compliance & CAPA Specialist

Samsung BioLogics Co.; 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 and vision benefits

Job summary

Samsung BioLogics Co. in Rockville, Maryland, is seeking an Engineering Services Compliance Specialist to support compliance activities across the Engineering Services department and maintain regulatory adherence.

Responsibilities include deviation management, CAPA administration, change control, risk assessments, and vendor management support, with emphasis on safety investigations and continuous improvement.

Qualifications

• Bachelor’s degree in engineering, Facilities Management, Business Administration, or related field.
• 3-5 years of industry experience (CAPA, deviation handling, change controls).
• 4+ years of practical work in pharmaceutical or FDA-regulated field with technical writing.

Responsibilities

• Oversee development and implementation of change control, CAPA, and deviation management.
• Provide guidance on compliance requirements and vendor management processes.
• Participate in safety and quality investigations; contribute to root cause analysis.
• Ensure efficient administrative and compliance-related tasks within the department.

Skills

Organizational skills

Problem solving

Decision making

Leadership

Team orientation

Interpersonal skills

Education

Bachelors degree in Engineering

Tools

Microsoft Word

Microsoft Excel

Microsoft Project

Job description

Samsung BioLogics Co. in Rockville, Maryland, is seeking an Engineering Services Compliance Specialist to support compliance activities across the Engineering Services department and maintain regulatory adherence.

Responsibilities include deviation management, CAPA administration, change control, risk assessments, and vendor management support, with emphasis on safety investigations and continuous improvement.