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Rockville, Maryland, United States · On-site
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Rockville, Maryland, United States · On-site
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Provide automation and control system engineering support for manufacturing operations, facilities, and capital projects. Ensure all systems comply with cGMP and regulatory requirements while providing 24/7 emergency support.
Requires a Bachelor's Degree and the ability to manage validation protocols such as IQ, OQ, and PQ. Candidates must be able to maintain documentation through approved change control methods.
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
Innovation, passion and an unwavering dedication to find breakthrough solutions in biomedicines.
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.
Offices: 300 Songdo Bio Way, Songdo, Incheon 21987, KR · 600 Gateway Blvd, San Francisco, California 94080, US · 100 Challenger Rd, New Jersey, New Jersey 07660, US · 260 Franklin St, Boston, Massachusetts 02110, US · Tokyo, Tokyo 102-0071, JP
