Engineering Services Compliance 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

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.