Engineering Services Compliance Specialist

Samsung BioLogics Co.; Rockville, Northern (MD, KY); Hybrid; 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, MD is seeking an Engineering Services Compliance Specialist to support regulatory compliance, deviation management, CAPA administration and change control within the Engineering Services department.

You will conduct risk assessments, assist vendor management, and participate in safety investigations, with a bachelor’s degree and 3–5 years in FDA-regulated environments. This full-time, in-person role offers a competitive salary range and benefits.

Qualifications

• Bachelor’s degree in engineering, facilities management, business administration, or a related field.
• Minimum of 3–5 years of industry-related experience (CAPA management, deviation handling, change controls).
• A minimum of 4 years of practical work experience in the pharmaceutical or other FDA-regulated field involving participation in technical writing.

Responsibilities

• Oversee development and implementation of change control, CAPA, and deviation management processes.
• Conduct work risk assessments to ensure compliance with regulatory and company standards.
• Provide guidance to business owners on compliance requirements and processes.
• Support the Vendor Management process.
• Participate in safety and quality investigations, contributing to root cause analysis and corrective action development.

Skills

Organization

Problem solving

Leadership

Team collaboration

Communication

MS Word/Excel/Project

Education

Bachelor’s degree in engineering, facilities management, business administration, or related field

Tools

MS Word

MS Excel

MS Project

Job description

## Engineering Services Compliance SpecialistApply: Fully In-Person: Rockville: Full time: Posted 2 Days Ago: R163The Engineering Services Compliance Specialist is responsible for supporting compliance activities within the Engineering Services department, including deviation management, CAPA administration, change control processes, risk assessments, vendor management support, and quality and safety investigations. This role ensures regulatory compliance, promotes continuous improvement, and supports operational excellence across facility and maintenance operations. **Key Responsibilities:** * Compliance Management: Oversee the development and implementation of change control, CAPA, and deviation management processes. Conduct work risk assessments to ensure compliance with regulatory and company standards.* Business Support: Provide guidance to business owners on compliance requirements and processes. Support the Vendor Management process.* Incident Investigation: Participate in safety and quality investigations, contributing to root cause analysis and corrective action development.* Administrative Support: Ensure efficient handling of administrative and compliance-related tasks within the department. **Requirements:** * Bachelor’s degree in engineering, Facilities Management, Business Administration, or a related field.* Minimum of 3-5 years of industry- related experience (CAPA management, deviation handling, change controls).* A minimum of 4 years of practical work experience in the pharmaceutical or other FDA regulated field involving participation in technical writing. **Skills/Abilities:** * Solid organization, problem-solving, decision-making, judgment, leadership, and team-oriented skills are essential to manage multiple projects of variable complexity.* Solid interpersonal skills are required in order to effectively communicate with all levels of the organization in various functional areas.* Microsoft Word, Excel and Project experience required. The anticipated salary range for this position in Maryland is $93,225 to $124,300 plus annual bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Benefits:· 13 paid holidays· Vacation time· 401K match· Medical, dental and vision benefits effective day one of employment