Senior Manager, Engineering Maintenance

About AGC Biologics

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.

SUMMARY:

The Senior Manager, Engineering Maintenance is accountable for all equipment maintenance operations and equipment sustainability. This position manages internal resources in the above stated areas, works with vendors and consultants as required, and participates as an active member of the site Engineering Leadership Team. This position is Incumbent is responsible for all Plant and Departmental goals, including reliability, cost reduction, waste reduction, sustainability, quality and equipment sanitation improvements, downtime reduction, cost improvement project implementation, as well as ensuring compliance with established policies and procedures. This position is accountable for developing appropriate maintenance structure, work systems, Key Performance Indicators, and people capabilities to maximize equipment uptime, efficiency, and throughput. The individual in this role must be comfortable working in a fast paced environment that is subject to long hours including evenings and on-call status. Some travel is also required.

PRINCIPAL RESPONSIBILTIES:

• Achieve sustainability goals around utilities, water, power, and solid waste.
• Ensure information flow, employee development, problem-solving, goal setting, performance evaluation, and process improvements by coaching, empowering, and supporting the Engineering Maintenance departments in a High Performance Work System (HPWS) environment.
• Assess and build technical capability of site employees across functions and levels.
• Develop, administer, and manage an operating budget for the Maintenance Department.
• Accountable for the development and implementation of effective preventive maintenance programs, along with the establishment of a proficient maintenance stores procurement and inventory control system, as applicable.
• Evaluate, monitor, and upgrade equipment PM strategy that result in a continuous reduction of MTBF and MTTR and increase an equipment/system uptime.
• Apply best practices and technology aligned with the biological development and manufacturing of product.
• Maintain the plant infrastructure.
• Coordinate the selection, design and layout of biological manufacturing equipment, and control systems to ensure efficiency & reliability.
• Initiate design changes and modifications to improve Process Reliability, meet cost reduction goals and reduce dependencies on manual labor on an on-going basis.
• Provide continuous leadership and guidance to maintenance, facility and utilities engineering personnel.
• Review operations and confer with technical or administrative staff to resolve equipment or processing problems.
• Develop positive partnerships with other operational functions (i.e. production or human resources) and suppliers to ensure human capital, equipment, production and sanitation processes are used in the most effective/efficient manner to meet or exceed manufacturing targets.
• Manage direct reports and provide leadership and guidance for their professional and personal development.
• Own and drive safety programs to ensure operations personnel are in compliance with federal/state and company policies and procedures.
• Meet with vendors and suppliers to learn about and evaluate products used in repair work.
• Compute estimates and actual costs of factors such as materials, labor, and outside contractors.
• Review, evaluate, accept, and coordinate completion of work bid from contractors.
• Interpret specifications, blueprints, and job orders to construct templates and lay out reference points for workers.
• Design input into equipment specification and design for maintainability and standarization.
• Recommend and/or manage continuous improvement in a way that engages employees and functional partners in systematic, effective and collaborative manner.
• Cooperate with managers and other leaders to ensure all Company legal and ethical requirements are met.
• Drive EHS and GMP compliance to ensure a successful compliance/safety culture.
• Participate in emergency and crisis management teams.
• Ensure all aspects of plant KPI'S are being reviewed and communicated to operations team and recommend ways to improve.
• Manage the Maintenance Training Program and conduct training to maintain compliance with Company and regulatory requirements.
• Drive Safety with supervisors and managers to ensure compliance with all Company policies, Standard Operating Procedures (SOP), Injury and Illness Prevention Program (IIPP), Hazard Communication, and Good Manufacturing Practices (GMP) as outlined in the Code of Federal Regulations, Title 21 - Section 210-211.
• Assist with the management of budget, expenses and P&L responsibilities effectively.
• Perform physical activities as outlined in the attached Physical Demands section of this position description.
• Manage special projects and perform other duties as assigned.
• Additional responsibilities not listed may be required of this position.

KNOWLEDGE, SKILLS & ABILITIES:

• Adaptable to a fast paced, shifting work environment, willing to remain flexible to accommodate changing business conditions, work requirements and scheduling needs.
• Attention to detail, ability to focus on the project or task at hand and consistently deliver error free results.
• Generate QA investigations and perform Root Cause Analysis to prevent recurrence.
• Strong analytical, problem solving and project management skills.
• Process engineering and analytical process mapping experience required.
• Ability to write reports, business correspondence and standard operating procedures.
• Hazard Analysis and Critical Control Points (HACCP) certification strongly preferred.
• FDA/GMP knowledge preferred.
• Excellent verbal and written communication skills; ability to communicate with multi-level audiences.
• Computer Skills / Special Equipment Knowledge: Computer skills – Microsoft Office skills (Excel, Word, Outlook).
• Computerized Maintenance Management System (CMMS) a plus.

EDUCATION/EXPERIENCE:

• Bachelor's degree from a four-Year College or university; or equivalent combination of education and experience required.
• A minimum of eight (8) years of manufacturing equipment maintenance experience with increasing levels of responsibility and authority.
• Hands on experience on AUTOCAD software, desirable.
• Experience using CMMS system (Maximo, BMRAM, etc.) required.
• Experience in the biotech and/or pharmaceutical manufacturing industry preferred.
• Experience working in an 24-hour production facility or critical utility environment preferred.
• Experienced working with plant system like: Purified Water, HVAC, Steam, Compressed air and Chilled water systems in addition to equipment like: reactors, mixers, centrifugal pumps, Centrifuges, etc.
• Experience implementing RCM and TPM maintenance approaches

COMPENSATION RANGE:

$142,960 - $196,570

Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.

Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.

Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company's performance and the Team Member's performance.

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.