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 Process Engineer - Reliability III/IV will be a highly qualified SME in manufacturing system reliability. This individual will be a critical member of our engineering team responsible for ensuring that equipment and processes operate at optimal levels and meet the needs of the organization's goals, which include but are not limited to increasing equipment uptime, reliability, and efficiency. The Reliability Engineer is a key member of the Engineering team and will be responsible for developing and implementing the strategic approach to maintenance and reliability for all site assets to increase the overall uptime and availability of systems and equipment and reduce the number of failures and downtime.

PRINCIPLE RESPONSIBILITIES:

• Lead cross-site working teams to analyze equipment failure data, conduct root cause and predictive analysis, and develop and implement new procedures and processes to monitor and implement current industry best practices specific to reliability-centered maintenance (RCM) and reporting systems.
• Conduct failure mode and effects analysis risk assessments and identify opportunities to eliminate loss and improve lifecycle asset management.
• Working with Engineering management, identify and implement Key Performance Indicators (KPI) and metrics, which drive system performance, maintenance efficiency, and asset utilization opportunities.
• Establish collaborative working relationships with other internal and external functions to identify processes for improvement, oversee and track progress, and lead participation in industry benchmarking activities.
• Work directly with the planning and spare parts teams to integrate robust maintenance planning and spare parts kitting to optimize maintenance technician utilization.
• Implement an Asset Reliability strategy that will maximize the Uptime of the assets, develop robust preventative maintenance plans, optimize spare parts inventory, embed predictive maintenance practices, and reduce the risk of having an unplanned failure.
• monitor life cycle asset management plans and periodically update maintenance job plans to improve reliability while meeting all of the quality standards set forth by the company and government regulations.
• Review the overall equipment effectiveness (OEE) of operations. The OOE is a measurement outlining manufacturing productivity.
• Implement new technologies and processes that can improve equipment performance and reliability.
• Developing and implementing training programs around reliability for employees.
• Collaborating with other departments to ensure that reliability is integrated into all aspects of the organization.

KNOWLEDGE, SKILLS & ABILITIES:

• Adaptable; must be willing to remain flexible to accommodate changing business conditions, work requirements and scheduling needs in a rapidly changing environment.
• Demonstrated attention to detail with the ability to focus on the project or task at hand and consistently deliver error free results
• Must be comfortable working in a fast paced environment and available to provide on-call support when needed
• Excellent organizational skills with ability to multi-task and prioritize.
• Demonstrated proficiency with all Windows based programs, knowledgeable with any CMMS program
• Excellent verbal and written communication skills; ability to communicate with multi-level audiences.
• Demonstrated ability to write investigations and standard operating procedures (SOP’s)

EDUCATION/EXPERIENCE:

• BS/MS in Engineering (Mechanical, Electrical, or Chemical) or Master highly preferable.
• Equivalent education and experience may substitute for stated requirements
• EIT or PE highly desirable.
• RCM Certification, required
• CMRP Certification, highly desirable
• CRE Certification, highly desirable
• Level III - Minimum of 5-7 years of relevant industry experience in Operational Engineering roles, supporting operations, improving performance. Five 5-7 years’ experience in pharmaceutical or other GMP-regulated industry and a Minimum of 5-7 years troubleshooting process automated systems in Biotech/Pharma Process.
• Senior: Minimum of 8 years of relevant industry experience in Operational Engineering roles, supporting operations, improving performance. 8 years’ experience in pharmaceutical or other GMP-regulated industry and a Minimum of 8 years troubleshooting process automated systems in Biotech/Pharma Process.
• Senior level experience in biotech industry (preferred).
• Experience working or implementing RCM, TPM programs.
• Experience performing risk and criticality assessments for process equipment and implement CBM (Condition-based monitoring) program via Vibration, ultrasonic, infra-red and oil testing regimes
• Experience managing a project team.
• Experience writing reports for senior colleagues outlining new concepts, testing outcomes, and ongoing efficiency.
• Demonstrated ability to develop and maintain clear and accurate documentation of process equipment or manufacturing processes.
• Equivalent education and experience may substitute for stated requirements

COMPENSATION RANGE:

$83,920-$148,610

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.