Engineering Services Compliance Specialist

Samsung Biologics•Rockville, MD

3d•$93,225 - $124,300•Onsite

About The Position

The 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.

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.
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.

Responsibilities

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.
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.
Ensure efficient handling of administrative and compliance-related tasks within the department.