Manager, Engineering

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

The Manager, Engineering, is responsible for leading and executing engineering-related activities on-site, including process, automation, capital projects, and the qualification of utilities, equipment, and facilities. This role involves managing internal company resources (assets, financial, and personnel) and collaborating with external professional engineering firms to execute equipment, facility, or utility modifications, upgrades, or expansion projects.

ESSENTIAL JOB DUTIES/RESPONSIBILITIES

• Lead and manage support activities and functions to ensure successful completion of engineering project objectives.
• Ensure all work carried out and equipment installed is safe, effective, and compliant with industry standards.
• Oversee capital projects involving planning, design, reconfiguration, construction, and qualification of facilities, utilities, and equipment with minimal direction.
• Direct process engineering transfer and optimization activities to ensure robust technical capability of manufacturing equipment.
• Ensure adherence to all company and site engineering policies and procedures.
• Maintain accurate and up-to-date engineering and project information files.
• Act as the principal liaison with professional engineering firms engaged in design and/or construction elements of projects.
• Manage site activities to ensure successful project execution, aligning with overall project timelines.
• Resolve technical issues or changes throughout the project lifecycle while adhering to scope, cost, and schedule objectives.
• Obtain and retain approval for engineering and facility designs from relevant departments, including manufacturing and quality.
• Ensure effective handover of facilities, utilities, and equipment to user departments and maintenance personnel.
• Proactively manage the site capital planning and execution processes.
• Develop long-term engineering and capital project plans.
• Adhere to all applicable procedures, cGMPs, company policies, and regulatory requirements (e.g., OSHA, DEA, FDA, EMEA, ANVISA, HS&E).
• Conduct technical review and evaluation of complex engineering processes.

LEADERSHIP SKILLS

• Ensures the professional development of direct reports and continuously includes coaching as part of leadership style.
• Enables direct reports to deal effectively with their responsibilities and follows up on work delegated to them.
• Ensures that the objectives of direct reports and meaningful and clearly defines the roles and priorities.
• Ensures direct reports have a clear understanding of their performance level and that performance assessments are used constructively to improve performance.
• Selects high-performing team members and creates high level of team spirit and engagement, promoting and living the core values.

QUALIFICATIONS

Required:

• Bachelor’s degree in Engineering or equivalent combination of education and experience.
• Minimum of 8 years of engineering management experience.
• Minimum of 10 years of engineering experience with increasing responsibility.
• Comprehensive technical knowledge of pharmaceutical equipment and plant design.
• Understanding of equipment and plant control systems (e.g., distributed control systems, high-speed equipment control, building management systems).
• Experience with pharmaceutical industry standards and requirements (minimum US GMP).
• Thorough knowledge of the validation process.
• Proven expertise in planning, organizing, and executing complex capital projects in a GMP environment.
• Experience developing integrated CAPEX site master plans.
• Demonstrated experience in RCA processes and solving complex issues.

Preferred:

• Master’s degree in Engineering or a related field.

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. 

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.  Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.