Senior Engineer, Instrumentation & Controls

Samsung Biologics is seeking a highly skilled and motivated Senior Instruments & Controls (I&C) Engineer to join our biopharmaceutical manufacturing site in Rockville, Maryland. The ideal candidate will have a minimum of 3 years of direct experience working within a cGMP manufacturing facility.

This role is critical in supporting our daily commercial manufacturing operations, executing capital projects, and ensuring reliability, safety, and compliance of our automated process equipment and utility systems.  The successful candidate will possess a deep understanding of biopharmaceutical process instrumentation, control system architectures, and regulatory requirements.

Key Responsibilities:

• Manufacturing Operations Support: Provide high-level technical troubleshooting and engineering support for commercial manufacturing operations, minimizing downtime and optimizing process robustness.
• System Maintenance & Reliability: Own the lifecycle management, calibration strategies, and loop tuning for site instrumentation (e.g., temperature, pressure, flow, pH, conductivity, and dissolved oxygen sensors) used in upstream and downstream processing.
• Capital Projects & Engineering: Act as the I&C subject matter expert (SME) on capital execution projects, from schematic design through detailed engineering, installation, and Bulk Mechanical Completion (BMC).
• Vendor & EPCM Management: Review vendor drawings, piping and instrumentation diagrams (P&IDs), loop sheets, and instrument specifications. Collaborating with EPCM firms and equipment integrators to ensure alignment with site technical standards.
• Commissioning, Qualification & Validation (CQV): Author, review, and execute engineering studies, commissioning protocols, and validation packages (IQ/OQ/PQ) for new and modified process equipment.
• Quality & Compliance: Author and manage technical deviations, root-cause analyses (CAPA), and change controls in compliance with corporate quality standards and regulatory mandates (FDA, EMA).

Required:

• Education: Bachelor’s degree in Electrical Engineering, Chemical Engineering, Mechanical Engineering, or a related technical discipline.
• Experience: Minimum of 3 years of direct engineering experience inside a pharmaceutical or biopharmaceutical manufacturing facility.
• Technical Knowledge: Comprehensive understanding of cGMP regulations, GAMP5 guidelines, and clean utility/process systems (such as bioreactors, UFDF skids, chromatography columns, CIP/SIP, and WFI systems).
• Instrumentation Expertise: Proficient in specifying, calibrating, and troubleshooting process instrumentation, control valves, and analytical transmitters.
• Control Systems: Familiarity with the integration of field instruments with Distributed Control Systems (DCS, e.g., DeltaV), Programmable Logic Controllers (PLCs, e.g., Allen-Bradley), and SCADA architectures.

Preferred:

• Experience leading the I&C scope on capital expansion projects.
• Familiarity with network protocols used in process automation (e.g., Profibus, Foundation Fieldbus, Ethernet/IP).
• Professional Engineer (P.E.) license is a plus.

Core Competencies

• Problem Solving: Demonstrated ability to perform root-cause analysis on complex automation and instrumentation failures under tight manufacturing timelines.
• Communication: Exceptional written and verbal communication skills, with the ability to translate complex technical issues to cross-functional stakeholders (Quality, Operations, Validation).
• Collaboration: Proven track record of working effectively in a team-oriented environment, managing third-party contractors and internal cross-functional alignment.

The anticipated salary range for this position in Maryland is $110,550 to $147,400 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