This is what you will do: Responsibilities Lead and oversee the Manufacturing Control System (MCS) for batch and continuous processes at the College Park facility.
Serve as the single point of contact for stakeholders and sustaining automation support for Gx P batch production.
Direct the design, implementation, and maintenance of Emerson Delta V MCS, ensuring optimal performance and reliability.
Lead complex troubleshooting, problem‑solving, and automation change initiatives, providing expertise to Engineering and Operations departments.
Develop and mentor a high‑performing team of engineers, fostering a culture of excellence, collaboration, and continuous learning.
Ensure MCS documentation, SOPs, change records, and deviation support comply with Gx P, FDA 21 CFR Part 11, and other regulatory standards.
Provide automation support for validation activities, internal and regulatory audits, and quality management systems.
Collaborate with other MCS user groups, and support colleague training and knowledge‑sharing.
Drive continuous improvement initiatives, leverage data dashboards (Power BI, etc.), and stay at the forefront of emerging automation trends.
Qualifications Bachelor's degree in Engineering or Computer Science (Process, Mechanical, Electrical, Electronic, or Controls) or equivalent professional experience.
At least 5 years of experience in process/automation industry supporting GMP environments.
At least 4 years of direct experience supporting automation systems in GMP biopharmaceutical production.
Direct experience and knowledge of Emerson Delta V process automation code platform.
Experience implementing change controls, supporting deviation or event records through Quality Management systems.
Proven track record as Subject Matter Expert to guide and lead other technical automation engineers.
Strong interpersonal, communication, and leadership skills to manage multiple initiatives in a matrixed environment.
Comprehensive understanding of c GMP requirements and automation change impact on product quality.
Preferred Advanced degree in Engineering or related discipline.
Experience with electronic Automation Change Management systems (e.g., KNEAT).
Understanding of batch process fundamentals and ability to consider multi‑product impact on automation code design decisions.
Familiarity with fundamentals of MCS integration with MES.
Experience with OSI PI data, Power BI, SQL Server, and IT experience.
Experience with hardware instrumentation layer integration with Delta V via Profibus and Ethernet to CHARMS.
Experience leading energy efficiency and sustainability efforts in manufacturing environments.
Application of LEAN or AGILE methodology.
In‑depth knowledge of regulatory standards (21 CFR Part 11, EU Annex 11).
Experience working with or alongside System Integrators/Vendors.
Date Posted26-Jan-2026 Closing Date25-Feb-2026
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