Automation Engineering

Samsung Biologics RKV; Rockville (MD); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

13 paid holidays

Vacation time

401K match

Medical, dental and vision insurance

Job summary

Samsung Biologics is seeking an Automation Engineer to support process control systems, manufacturing equipment, building systems, and plant utilities at the Rockville, MD facility. You will provide automation and control system engineering support for manufacturing operations, facilities, validation activities, and capital projects while ensuring compliance with cGMP and regulatory requirements.

The role requires a Bachelor's Degree and offers a competitive salary with annual bonus eligibility

Qualifications

• Troubleshoot and optimize equipment/systems across manufacturing and facilities.
• Provide validation support including IQ/OQ/PQ documentation.
• Ensure compliance with cGMP, SOPs and regulatory requirements.

Responsibilities

• Troubleshoot, optimize, test, and challenge equipment/systems in collaboration with manufacturing, facilities, lab and QA.
• Provide engineering support for work requests and project execution to meet requirements and timelines.
• Ensure projects are compliant with cGMP, SOPs, OSHA and applicable codes.
• Maintain cGMP equipment/system modifications via change control; support validation protocols.
• Provide 24/7 emergency support to ongoing manufacturing operations.

Skills

Troubleshooting

Testing

Project execution

cGMP compliance

Validation

Change control

IQ/OQ/PQ

Communication

Emergency support

Education

Bachelor's Degree

Job description

Samsung Biologics is seeking an Automation Engineer to support process control systems, manufacturing equipment, building systems, and plant utilities at the Rockville, MD facility.

This role is responsible for providing automation and control system engineering support for manufacturing operations, facilities, validation activities, and capital projects while ensuring compliance with cGMP and regulatory requirements.

KEY RESPONSIBILITIES

• Support/Interact with manufacturing/facility/lab/validation/quality groups to troubleshoot, optimize, test, and/or challenge equipment/systems
• Provide engineering support for work requests for assigned area and project execution to ensure requirements are met, timelines are met, customer needs are addressed and projects align with GSK goals
• Ensure all projects are compliant (cGMP, SOPs, OSHA, NFP, BOCA/IBC, Local and National Codes, etc.) and are executed with good engineering practice
• Ensure a high level of compliance with cGMP and other regulatory requirements such as validation
• Maintain and document all cGMP equipment/system modifications and upgrades through approved change control methods
• Provide technical content and support for the generation of validation protocols; such as, Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)
• Communicate concerns and issues of staff, project status, performance and suggestions for improvement to management
• Provide 24/7 emergency support to ongoing manufacturing operations

Education

Bachelor's Degree

The anticipated salary range for this position in Maryland is $120,000 to $160,000 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.