BMS Lead Automation Engineer
2 weeks ago
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The Building Management System (BMS) Lead Automation Engineer is the system owner of two key foundation Manufacturing Systems within College Park:
- The Non–Qualified Building Management System (NQBMS) which controls & monitors the sites' Air Handling Units, Black Utilities & Waste Water systems.
- The Qualified Building Management System (QBMS) which monitors the sites' GMP cleanroom environmental conditions, Cold & Freezer Rooms & Controlled Temperature Units (CTUs).
We are seeking an experienced and motivated Lead Engineer to oversee and manage both these systems within our state-of-the-art pharmaceutical manufacturing facility.
In this critical role, you will lead the design, maintenance, and optimisation of BMS infrastructure, ensuring compliance with regulatory standards and operational excellence. Experience with Siemens Desigo systems is highly desirable, as is a strong background in managing BMS in a GxP-regulated environment.
You will be responsible for:
- Lead the operation, maintenance, and optimisation of Qualified (GxP) and Non-Qualified (non-GxP) Building Management Systems, ensuring seamless functionality across the facility.
- Oversee the design, configuration, and commissioning of BMS infrastructure, with a focus on maintaining system reliability and compliance.
- Serve as the technical lead for Siemens Desigo-based systems, leveraging expertise to optimise system performance and troubleshoot complex issues.
Regulatory Compliance and Qualification
- Ensure compliance with pharmaceutical industry regulatory requirements (e.g., GxP, FDA 21 CFR Part 11, EU Annex 11) for the QBMS system.
- Maintain complete and accurate documentation for Qualified and Non-Qualified systems, including change control, SOPs, and Automation Change Packs (ACPs).
Leadership and Collaboration
- Act as a subject matter expert (SME) for BMS, providing guidance and mentorship to junior engineers and technicians.
- Collaborate with cross-functional teams, including manufacturing, quality assurance, and facilities management, to ensure alignment of BMS operations with business needs.
- Manage relationships with external vendors and contractors, ensuring timely and cost-effective delivery of services and upgrades.
Continuous Improvement and Innovation
- Identify opportunities to improve system performance, energy efficiency, and sustainability.
- Stay up to date with emerging trends and technologies in BMS and apply innovative solutions to enhance operational efficiency.
- Develop and implement best practices for BMS operations, maintenance, and compliance in a pharmaceutical manufacturing environment.
You will need to have:
Essential Qualifications
- Bachelor's degree in Engineering (e.g., Mechanical, Electrical, Controls, or related field) or equivalent professional experience.
- 3+ years of experience managing Building Management Systems (BMS) in a pharmaceutical or regulated manufacturing facility.
- Strong understanding of Qualified (GxP) and Non-Qualified systems and their application in pharmaceutical manufacturing environments.
- Experience with Siemens Desigo or similar BMS platforms, including system configuration, troubleshooting, and optimisation.
- Proficiency in regulatory standards and requirements for BMS in a pharmaceutical context (e.g., 21 CFR Part 11, EU Annex 11).
Technical Skills
- Expertise in BMS infrastructure, including HVAC controls, environmental monitoring, and energy management systems.
- Knowledge of integration protocols such as BACnet, Modbus, or OPC for system interoperability.
- Experience with qualification/validation processes & Change Control.
Soft Skills
- Strong leadership and project management skills, with the ability to prioritize and manage multiple projects simultaneously.
- Excellent communication and collaboration skills to effectively engage with cross-functional teams, vendors, and stakeholders.
- Analytical mindset with attention to detail and a proactive approach to problem-solving.
We would prefer for you to have:
- Advanced degree in Engineering or a related field.
- Experience with energy efficiency initiatives or sustainability programs in manufacturing facilities.
- Familiarity with other BMS platforms besides Siemens Desigo.
- Background in managing facility systems in a large-scale pharmaceutical or biotech manufacturing setting.
Date Posted
04-Feb-2025
Closing Date
17-Feb-2025
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact. Alexion participates in E-Verify.
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