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 GxP batch production.
- Direct the design, implementation, and maintenance of Emerson DeltaV 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 GxP, 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 (PowerBI, 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 DeltaV 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 cGMP 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, PowerBI, SQL Server, and IT experience.
- Experience with hardware instrumentation layer integration with DeltaV 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 Posted
26-Jan-2026
Closing Date
25-Feb-2026
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