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Gaithersburg, MD

Senior Director of Engineering

Senior Director of Engineering

FPC of Atlanta

FPC of Atlanta

Highly respected Biopharmaceutical Company seeks a Senior Director of Engineering to direct engineering and maintenance activities at this commercial scale biopharmaceutical manufacturing facility, ensuring compliance with regulations, driving continuous improvement, and managing site investments for the long term.
Responsibilities:
• Lead engineering and maintenance activities at the site.
• Serve on the Site Leadership Team and function as a Process Safety Champion.
• Ensure compliance with Global Engineering Standards and EH&S requirements.
• Promote energy reduction and sustainability initiatives for bio-pharm processes.
• Direct engineering efforts in designing, procuring, installing, and commissioning plant systems and equipment.
• Troubleshoot and improve systems to achieve operational reliability and site objectives.
• Oversee automation efforts to meet operational goals.
• Ensure equipment, processes, and systems comply with safety and regulatory guidelines.
• Manage site maintenance activities, including utilities operation and preventative maintenance programs.
• Prepare and manage site facility capital programs within budget.
• Drive site engineering safety efforts and manage relationships with stakeholders.
• Function as Duty Holder for safety critical programs and take ownership of program results.
 
Requirements:
• Bachelor's degree in Engineering (Mechanical, Electrical, Computer Science, Chemical, Civil).
• 10+ years of experience in Biologics, Vaccines, Monoclonal Antibodies, or related fields.
• Understanding of biologic drug substance processes.
• Experience managing engineering teams.
• Project management experience and capital investment knowledge.
• Familiarity with pharmaceutical facility design, construction, and startup. 
• Knowledge of cGMPs and bioprocessing requirements.
• Experience in a large pharmaceutical company with the ability to navigate the dynamics of both site based and corporate engineering roles and expectations.
• Budgeting skills and project management expertise.
• Strong interpersonal and leadership skills for team collaboration.
• Ability to lead cross-functional teams and drive continuous improvement initiatives.
 
The company provides a highly impactful and visible leadership opportunity, competitive compensation including salary, bonus, LTI, excellent benefits and full relocation if required.
 

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