Sr Reliability Engineer 1
Posted on Oct 7, 2024 by Fujifilm
Holly Springs, NC
Engineering
Immediate Start
Annual Salary
Full-Time
Overview:
Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.
Join us
We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.
The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.
External US:
About This Role
The Senior Reliability Engineer is responsible for life cycle asset management. This role monitors equipment performance and identifies and mitigates issues related to system and equipment reliability. Additionally, this role works with the Plant Engineering team to develop maintenance strategies to optimize equipment performance. This role functions as a maintenance lead in root cause analysis, analyzing equipment failures, and creating predictive forecasts for system optimization.
What You’ll Do
Analyzes data of corrective work orders in the Computerized Maintenance Management System (CMMS) and Quality Event Metrics (QEM) to identify trends and areas of improvements
Assesses risk and reliability of assets associated with manufacturing and support systems including but not limited to failure mode analysis, mean time to failure (MTTF), and mean time to repair (MTTR)
Develops and maintains the Reliability Centered Maintenance (RCM) strategy to optimize maintenance programs within assigned area
Participates in the development and implementation of other continuous improvement initiatives
Establishes and maintains Key Performance Indicators (KPIs) for the overall health of the critical utility and process systems and builds tools to exercise and evaluate KPIs
Implements measures to baseline maintenance performance and improvement targets as they relate to cost, quality, downtime, etc.
Provides reliability, technical, and engineering services and guidance to optimize asset life and resolution to equipment design and operations
Collaborates with other departments (e.g., Manufacturing, Maintenance, and Validation) to identify and solve problems while ensuring reliability is effectively integrated throughout the site
Conducts training and presents information to team or other stakeholders, as needed
Other duties, as assigned
Who You Are
You will monitor equipment performance and identifies and mitigates issues related to system and equipment reliability.
Basic Requirements
Bachelor’s degree in Mechanical or Electrical Engineering, or another related field
8 years of Engineering and/or Maintenance experience
Experience with Engineering drawings and Quality Systems (e.g., deviation management, change control, corrective and preventive action (CAPA), document management system)
Effective communication, both written and oral
Advanced problem-solving skills
Ability to effectively present complex information to others
Ability to provide feedback to others, including leaders
Willingness to partner with global colleagues and lead sub teams
Knowledge of Good Manufacturing Practices (GMP), Good Engineering Practices (GEP), and Food & Drug Administration (FDA) regulations
Knowledge of RCM and/or Total productive Maintenance (TPM)
Knowledge of process improvement and reliability engineering principles, methodologies, and tools such as PDCA, LEAN, Six Sigma / DMAIC, FMEA
Knowledge of the operation and interdependencies of typical utility systems in a pharmaceutical plant (e.g., chillers and cooling towers), boilers/plant steam, utility piping & distribution systems, HVAC, electrical distribution systems, and pharmaceutical RODI, Clean Steam (CS), and
Water for Injection (WFI) systems)
Preferred Requirements
Master’s degree in Mechanical or Electrical Engineering with 6+ years of Engineering or other relevant technical experience
Prior experience working in a cGMP environment or other highly regulated industry
Experience implementing KPIs and other reliability metrics
Certified Maintenance and Reliability Professional
Six Sigma
Working Conditions & Physical Requirements
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.
Ability to discern audible cues.
Ability to ascend or descend ladders, scaffolding, ramps, etc.
Ability to stand for prolonged periods of time up to 120 minutes.
Ability to sit for prolonged periods of time up to 120 minutes
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.
FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email .
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid
agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.
Join us
We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.
The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.
External US:
About This Role
The Senior Reliability Engineer is responsible for life cycle asset management. This role monitors equipment performance and identifies and mitigates issues related to system and equipment reliability. Additionally, this role works with the Plant Engineering team to develop maintenance strategies to optimize equipment performance. This role functions as a maintenance lead in root cause analysis, analyzing equipment failures, and creating predictive forecasts for system optimization.
What You’ll Do
Analyzes data of corrective work orders in the Computerized Maintenance Management System (CMMS) and Quality Event Metrics (QEM) to identify trends and areas of improvements
Assesses risk and reliability of assets associated with manufacturing and support systems including but not limited to failure mode analysis, mean time to failure (MTTF), and mean time to repair (MTTR)
Develops and maintains the Reliability Centered Maintenance (RCM) strategy to optimize maintenance programs within assigned area
Participates in the development and implementation of other continuous improvement initiatives
Establishes and maintains Key Performance Indicators (KPIs) for the overall health of the critical utility and process systems and builds tools to exercise and evaluate KPIs
Implements measures to baseline maintenance performance and improvement targets as they relate to cost, quality, downtime, etc.
Provides reliability, technical, and engineering services and guidance to optimize asset life and resolution to equipment design and operations
Collaborates with other departments (e.g., Manufacturing, Maintenance, and Validation) to identify and solve problems while ensuring reliability is effectively integrated throughout the site
Conducts training and presents information to team or other stakeholders, as needed
Other duties, as assigned
Who You Are
You will monitor equipment performance and identifies and mitigates issues related to system and equipment reliability.
Basic Requirements
Bachelor’s degree in Mechanical or Electrical Engineering, or another related field
8 years of Engineering and/or Maintenance experience
Experience with Engineering drawings and Quality Systems (e.g., deviation management, change control, corrective and preventive action (CAPA), document management system)
Effective communication, both written and oral
Advanced problem-solving skills
Ability to effectively present complex information to others
Ability to provide feedback to others, including leaders
Willingness to partner with global colleagues and lead sub teams
Knowledge of Good Manufacturing Practices (GMP), Good Engineering Practices (GEP), and Food & Drug Administration (FDA) regulations
Knowledge of RCM and/or Total productive Maintenance (TPM)
Knowledge of process improvement and reliability engineering principles, methodologies, and tools such as PDCA, LEAN, Six Sigma / DMAIC, FMEA
Knowledge of the operation and interdependencies of typical utility systems in a pharmaceutical plant (e.g., chillers and cooling towers), boilers/plant steam, utility piping & distribution systems, HVAC, electrical distribution systems, and pharmaceutical RODI, Clean Steam (CS), and
Water for Injection (WFI) systems)
Preferred Requirements
Master’s degree in Mechanical or Electrical Engineering with 6+ years of Engineering or other relevant technical experience
Prior experience working in a cGMP environment or other highly regulated industry
Experience implementing KPIs and other reliability metrics
Certified Maintenance and Reliability Professional
Six Sigma
Working Conditions & Physical Requirements
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.
Ability to discern audible cues.
Ability to ascend or descend ladders, scaffolding, ramps, etc.
Ability to stand for prolonged periods of time up to 120 minutes.
Ability to sit for prolonged periods of time up to 120 minutes
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.
FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email .
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid
agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
Reference: 200080910
https://jobs.careeraddict.com/post/95877120
Sr Reliability Engineer 1
Posted on Oct 7, 2024 by Fujifilm
Holly Springs, NC
Engineering
Immediate Start
Annual Salary
Full-Time
Overview:
Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.
Join us
We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.
The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.
External US:
About This Role
The Senior Reliability Engineer is responsible for life cycle asset management. This role monitors equipment performance and identifies and mitigates issues related to system and equipment reliability. Additionally, this role works with the Plant Engineering team to develop maintenance strategies to optimize equipment performance. This role functions as a maintenance lead in root cause analysis, analyzing equipment failures, and creating predictive forecasts for system optimization.
What You’ll Do
Analyzes data of corrective work orders in the Computerized Maintenance Management System (CMMS) and Quality Event Metrics (QEM) to identify trends and areas of improvements
Assesses risk and reliability of assets associated with manufacturing and support systems including but not limited to failure mode analysis, mean time to failure (MTTF), and mean time to repair (MTTR)
Develops and maintains the Reliability Centered Maintenance (RCM) strategy to optimize maintenance programs within assigned area
Participates in the development and implementation of other continuous improvement initiatives
Establishes and maintains Key Performance Indicators (KPIs) for the overall health of the critical utility and process systems and builds tools to exercise and evaluate KPIs
Implements measures to baseline maintenance performance and improvement targets as they relate to cost, quality, downtime, etc.
Provides reliability, technical, and engineering services and guidance to optimize asset life and resolution to equipment design and operations
Collaborates with other departments (e.g., Manufacturing, Maintenance, and Validation) to identify and solve problems while ensuring reliability is effectively integrated throughout the site
Conducts training and presents information to team or other stakeholders, as needed
Other duties, as assigned
Who You Are
You will monitor equipment performance and identifies and mitigates issues related to system and equipment reliability.
Basic Requirements
Bachelor’s degree in Mechanical or Electrical Engineering, or another related field
8 years of Engineering and/or Maintenance experience
Experience with Engineering drawings and Quality Systems (e.g., deviation management, change control, corrective and preventive action (CAPA), document management system)
Effective communication, both written and oral
Advanced problem-solving skills
Ability to effectively present complex information to others
Ability to provide feedback to others, including leaders
Willingness to partner with global colleagues and lead sub teams
Knowledge of Good Manufacturing Practices (GMP), Good Engineering Practices (GEP), and Food & Drug Administration (FDA) regulations
Knowledge of RCM and/or Total productive Maintenance (TPM)
Knowledge of process improvement and reliability engineering principles, methodologies, and tools such as PDCA, LEAN, Six Sigma / DMAIC, FMEA
Knowledge of the operation and interdependencies of typical utility systems in a pharmaceutical plant (e.g., chillers and cooling towers), boilers/plant steam, utility piping & distribution systems, HVAC, electrical distribution systems, and pharmaceutical RODI, Clean Steam (CS), and
Water for Injection (WFI) systems)
Preferred Requirements
Master’s degree in Mechanical or Electrical Engineering with 6+ years of Engineering or other relevant technical experience
Prior experience working in a cGMP environment or other highly regulated industry
Experience implementing KPIs and other reliability metrics
Certified Maintenance and Reliability Professional
Six Sigma
Working Conditions & Physical Requirements
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.
Ability to discern audible cues.
Ability to ascend or descend ladders, scaffolding, ramps, etc.
Ability to stand for prolonged periods of time up to 120 minutes.
Ability to sit for prolonged periods of time up to 120 minutes
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.
FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email .
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid
agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.
Join us
We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.
The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.
External US:
About This Role
The Senior Reliability Engineer is responsible for life cycle asset management. This role monitors equipment performance and identifies and mitigates issues related to system and equipment reliability. Additionally, this role works with the Plant Engineering team to develop maintenance strategies to optimize equipment performance. This role functions as a maintenance lead in root cause analysis, analyzing equipment failures, and creating predictive forecasts for system optimization.
What You’ll Do
Analyzes data of corrective work orders in the Computerized Maintenance Management System (CMMS) and Quality Event Metrics (QEM) to identify trends and areas of improvements
Assesses risk and reliability of assets associated with manufacturing and support systems including but not limited to failure mode analysis, mean time to failure (MTTF), and mean time to repair (MTTR)
Develops and maintains the Reliability Centered Maintenance (RCM) strategy to optimize maintenance programs within assigned area
Participates in the development and implementation of other continuous improvement initiatives
Establishes and maintains Key Performance Indicators (KPIs) for the overall health of the critical utility and process systems and builds tools to exercise and evaluate KPIs
Implements measures to baseline maintenance performance and improvement targets as they relate to cost, quality, downtime, etc.
Provides reliability, technical, and engineering services and guidance to optimize asset life and resolution to equipment design and operations
Collaborates with other departments (e.g., Manufacturing, Maintenance, and Validation) to identify and solve problems while ensuring reliability is effectively integrated throughout the site
Conducts training and presents information to team or other stakeholders, as needed
Other duties, as assigned
Who You Are
You will monitor equipment performance and identifies and mitigates issues related to system and equipment reliability.
Basic Requirements
Bachelor’s degree in Mechanical or Electrical Engineering, or another related field
8 years of Engineering and/or Maintenance experience
Experience with Engineering drawings and Quality Systems (e.g., deviation management, change control, corrective and preventive action (CAPA), document management system)
Effective communication, both written and oral
Advanced problem-solving skills
Ability to effectively present complex information to others
Ability to provide feedback to others, including leaders
Willingness to partner with global colleagues and lead sub teams
Knowledge of Good Manufacturing Practices (GMP), Good Engineering Practices (GEP), and Food & Drug Administration (FDA) regulations
Knowledge of RCM and/or Total productive Maintenance (TPM)
Knowledge of process improvement and reliability engineering principles, methodologies, and tools such as PDCA, LEAN, Six Sigma / DMAIC, FMEA
Knowledge of the operation and interdependencies of typical utility systems in a pharmaceutical plant (e.g., chillers and cooling towers), boilers/plant steam, utility piping & distribution systems, HVAC, electrical distribution systems, and pharmaceutical RODI, Clean Steam (CS), and
Water for Injection (WFI) systems)
Preferred Requirements
Master’s degree in Mechanical or Electrical Engineering with 6+ years of Engineering or other relevant technical experience
Prior experience working in a cGMP environment or other highly regulated industry
Experience implementing KPIs and other reliability metrics
Certified Maintenance and Reliability Professional
Six Sigma
Working Conditions & Physical Requirements
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.
Ability to discern audible cues.
Ability to ascend or descend ladders, scaffolding, ramps, etc.
Ability to stand for prolonged periods of time up to 120 minutes.
Ability to sit for prolonged periods of time up to 120 minutes
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.
FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email .
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid
agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
Reference: 200080910
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