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.
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 and is responsible for all Plant and Departmental goals, including reliability, cost reduction, waste reduction, sustainability, quality and equipment sanitation improvements, downtime reduction, and cost improvement project implementation, as well as ensuring compliance with established policies and procedures. This position is accountable for developing appropriate maintenance structures, 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 RESPONSIBILITIES:
- 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 the 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 results in a continuous reduction of MTBF and MTTR and increases equipment/system uptime.
- Apply best practices and technology aligned with the biological development and manufacturing of products.
- 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 ongoing 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 bids 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 standardization.
- Recommend and/or manage continuous improvement in a way that engages employees and functional partners in a 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 are being reviewed and communicated to the 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 for 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 is 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) is 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 with AUTOCAD software is desirable.
- Experience using CMMS systems (Maximo, BMRAM, etc.) is required.
- Experience in the biotech and/or pharmaceutical manufacturing industry preferred.
- Experience working in a 24-hour production facility or critical utility environment preferred.
- Experienced working with plant systems 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
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.
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.
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