Engineering Services Compliance Specialist

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. 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. Salary 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 Samsung Biologics is a fully integrated CDMO offering state-of-the-art contract development and manufacturing services. With proven regulatory approvals, the largest capacity, and the fastest throughput, Samsung Biologics is an award‑winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide. #J-18808-Ljbffr Samsung Biologics RKV