Johnson & Johnson companies are equal opportunity employers.
Principal Engineer, Risk Management and Criticality Analysis-00000UO8
Description
Janssen Supply Group, LLC is recruiting for a Principal Engineer, Risk Management and Criticality Analysis. The position can be located in Raritan, NJ; Titusville, NJ; Spring House, PA; Malvern, PA; Horsham, PA; Gurabo, PR; Beerse, Belgium; or Schaffhausen, Switzerland.
Janssen Pharmaceuticals Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including in oncology, immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. Janssen Supply Group, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Janssen Supply Group, LLC is part of Janssen Supply Chain, a global organization responsible for supplying medicines to markets around the world. With Quality as their primary focus, this group strives to provides access and affordability through innovation and strong collaboration with their R&D and Commercial partners to deliver life changing solutions for patients in need.
The Principal Engineer, Combo Products, Risk Management and Criticality Analysis serves as a subject matter expert for CTQ Flow Down, Risk Analysis, Criticality Analysis and Risk Management. The Principal Engineer leads the implementation of risk management processes, procedures, training and tools reporting into DtV and PQM. This position leads the risk management program within JSC, conducting a variety of risk assessments, ensuring compliance with relevant government and company policies. The Principal Engineer will serve as global resource to the entire Quality organization to provide guidance, training, consultation and quality oversight for risk management quality systems and quality requirements.
The Principal Engineer, Risk Management and Criticality Analysis leads the risk management program within JSC, ensuring compliance for Janssen’s portfolio of products with relevant government and company policies, including ISO 14971 Risk Management, EN 62366 Human Factors, and ICHQ9. The individual will be responsible for the execution of quality risk management for the Janssen portfolio of products, proactive site and product scans, criticality assessment, CTQ Flow down, and risk reduction plans. In coordination with the Site QRM Product/Process Owners and the Quality organization, works to develop and implement a sustainable framework of Quality Risk Management processes/procedures, tools, training and metrics to monitor the ongoing QRM program. He/she supports criticality analysis and DtV functions by identifying mitigating and communicating compliance and quality risks through use of the prescribed tools ensuring that Quality Risk Management is incorporated throughout the lifecycle of the products and processes. Reduction in risk shall be determined and communicated for PPQS, DtV and CA projects. Evaluates and communicates quality and compliance risk(s). Recommends, initializes and/or sponsor corrective actions and continuous improvement. Participates in, and leads as appropriate, investigations. The Principal Engineer is a team member in the development of risk management standards and best practices documentation required to support QRM program. Ensures risk management procedures are harmonized, integrated and understood by key business partners across multiple departments and plant locations. Acts as a change agent for project teams and the organization relative to a new way of working. Coaches, mentors and trains team members throughout project execution. The individual participates and leads data driven risk assessments (risk identification, analysis and evaluation), formulates risk mitigation and control strategies, and ensures periodic risk review. Implements risk assessment approaches including the use of process mapping and preliminary risk assessment for determination of the Critical Quality Attributes and Critical Process Parameters. He/she participates in and supports inspections by internal and external regulatory authorities globally and is responsible for adhering to environmental and safety policy and procedures and supports department environmental and safety objectives.
The Principal Engineer, Risk Management and Criticality Analysis leads the successful execution of quality risk management for the Janssen portfolio of products, including proactive site and product scans, criticality assessment, CTQ Flow down, and risk reduction plans. This includes being a team member in the development of new quality frameworks for emerging platforms/technologies. Supports criticality analysis and DtV functions by identifying mitigating and communicating compliance and quality risks through use of the prescribed tools ensuring that Quality Risk Management is incorporated throughout the lifecycle of the products and processes. Reduction in risk shall be determined and communicated for PPQS, DtV and CA projects. Evaluates and communicates quality and compliance risk(s). Recommends, initializes and/or sponsor corrective actions and continuous improvement. Participates in, and leads as appropriate, investigations. Responsible for ensuring Janssen has adequate core knowledge and bench strength as it relates to Risk Management. Provide Coaching & Development for risk management and appropriate application of risk management tools. The individual is involved with Inspectional Support as needed, and reviews regulatory submissions and supporting documentation. Responsible for ensuring personal and company compliance with all federal, state, local, and company regulations, policies, and procedures for health, safety, and environmental compliance. He/she will drive continuous improvement throughout department to ensure most efficient use of resources to deliver value-added support; Establishes and maintains best practices, ideas and methodologies. Collaborates with all stakeholders and business partners to meet goals and objectives, identify opportunities and drive projects forward. Builds networks to maintain trust. Participates in J&J and Pharma sector initiatives related to device, combination product and emerging technologies product development and Quality Systems and other related duties as assigned by management.
Qualifications
A minimum of a Bachelor’s Degree in a scientific related field is required. A minimum of 5 years of experience in MD&D manufacturing and/or pharmaceutical, and broad scientific expertise is required. A strong device background is required. Proven experience in leading complex projects and improvement initiatives, projects and groups of professionals is required. Multifunctional background preferred. Demonstrated experience leading matrix teams required. Proficient in CTQ Flow down and Criticality Analysis methodologies is required. Demonstrated competence in the application of QRM principles as they relate to Quality by Design and current Device and Pharmaceutical Risk based process validation requirements is preferred. Experience in authoring QRM plans and Quality Risk Communication reports is preferred. Experience working in an FDA regulated industry is required. Understanding / knowledge of Quality Systems, including ISO 14971, EN 62366 and ICHQ9 Requirements is required. Knowledge of Devices, Biotech and/or Pharma Manufacturing is required, particularly in technology transfer / design transfer, Design Controls and Risk Management. Design Excellence or Six Sigma Black Best or Master Black Belt preferred. FPX Certified, CQE or CQM preferred. Excellent technical writing skills; experienced in SOPs, protocols, reports required. Versed in computing platforms such as MS Excel and Minitab are required. Experience with Cognition Cockpit is preferred. Working knowledge of Statistical Methods / Process is required.
A deep understanding of product and process development process and associated regulatory and quality requirements is required. Demonstrated systems thinking, with strong analytical, technical, problem solving and organizational skills required. The ability to communicate with Subject Matter Experts, QRM Decision Makers and other QRM Stakeholders is required. The ability to drive and conduct, if required, risk assessments and to serve as a facilitator in the use of QRM tools is required. Must understand business needs and have the ability to relate these to scientific concepts.
This position may require 25% travel, domestic and international, and could be higher at times based upon business needs.
Primary Location:North America-United States-New Jersey-Raritan
Other Locations:North America-United States-Pennsylvania-Horsham, North America-United States-Pennsylvania-Malvern, Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen, North America-United States-Pennsylvania-Spring House, North America-United States-Puerto Rico-Gurabo, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: JANSSEN SUPPLY GROUP, LLC (6046)
Job Function: Engineering (Generalist)
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
Principal Engineer, Risk Management and Criticality Analysis-00000UO8
Description
Janssen Supply Group, LLC is recruiting for a Principal Engineer, Risk Management and Criticality Analysis. The position can be located in Raritan, NJ; Titusville, NJ; Spring House, PA; Malvern, PA; Horsham, PA; Gurabo, PR; Beerse, Belgium; or Schaffhausen, Switzerland.
Janssen Pharmaceuticals Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including in oncology, immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. Janssen Supply Group, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Janssen Supply Group, LLC is part of Janssen Supply Chain, a global organization responsible for supplying medicines to markets around the world. With Quality as their primary focus, this group strives to provides access and affordability through innovation and strong collaboration with their R&D and Commercial partners to deliver life changing solutions for patients in need.
The Principal Engineer, Combo Products, Risk Management and Criticality Analysis serves as a subject matter expert for CTQ Flow Down, Risk Analysis, Criticality Analysis and Risk Management. The Principal Engineer leads the implementation of risk management processes, procedures, training and tools reporting into DtV and PQM. This position leads the risk management program within JSC, conducting a variety of risk assessments, ensuring compliance with relevant government and company policies. The Principal Engineer will serve as global resource to the entire Quality organization to provide guidance, training, consultation and quality oversight for risk management quality systems and quality requirements.
The Principal Engineer, Risk Management and Criticality Analysis leads the risk management program within JSC, ensuring compliance for Janssen’s portfolio of products with relevant government and company policies, including ISO 14971 Risk Management, EN 62366 Human Factors, and ICHQ9. The individual will be responsible for the execution of quality risk management for the Janssen portfolio of products, proactive site and product scans, criticality assessment, CTQ Flow down, and risk reduction plans. In coordination with the Site QRM Product/Process Owners and the Quality organization, works to develop and implement a sustainable framework of Quality Risk Management processes/procedures, tools, training and metrics to monitor the ongoing QRM program. He/she supports criticality analysis and DtV functions by identifying mitigating and communicating compliance and quality risks through use of the prescribed tools ensuring that Quality Risk Management is incorporated throughout the lifecycle of the products and processes. Reduction in risk shall be determined and communicated for PPQS, DtV and CA projects. Evaluates and communicates quality and compliance risk(s). Recommends, initializes and/or sponsor corrective actions and continuous improvement. Participates in, and leads as appropriate, investigations. The Principal Engineer is a team member in the development of risk management standards and best practices documentation required to support QRM program. Ensures risk management procedures are harmonized, integrated and understood by key business partners across multiple departments and plant locations. Acts as a change agent for project teams and the organization relative to a new way of working. Coaches, mentors and trains team members throughout project execution. The individual participates and leads data driven risk assessments (risk identification, analysis and evaluation), formulates risk mitigation and control strategies, and ensures periodic risk review. Implements risk assessment approaches including the use of process mapping and preliminary risk assessment for determination of the Critical Quality Attributes and Critical Process Parameters. He/she participates in and supports inspections by internal and external regulatory authorities globally and is responsible for adhering to environmental and safety policy and procedures and supports department environmental and safety objectives.
The Principal Engineer, Risk Management and Criticality Analysis leads the successful execution of quality risk management for the Janssen portfolio of products, including proactive site and product scans, criticality assessment, CTQ Flow down, and risk reduction plans. This includes being a team member in the development of new quality frameworks for emerging platforms/technologies. Supports criticality analysis and DtV functions by identifying mitigating and communicating compliance and quality risks through use of the prescribed tools ensuring that Quality Risk Management is incorporated throughout the lifecycle of the products and processes. Reduction in risk shall be determined and communicated for PPQS, DtV and CA projects. Evaluates and communicates quality and compliance risk(s). Recommends, initializes and/or sponsor corrective actions and continuous improvement. Participates in, and leads as appropriate, investigations. Responsible for ensuring Janssen has adequate core knowledge and bench strength as it relates to Risk Management. Provide Coaching & Development for risk management and appropriate application of risk management tools. The individual is involved with Inspectional Support as needed, and reviews regulatory submissions and supporting documentation. Responsible for ensuring personal and company compliance with all federal, state, local, and company regulations, policies, and procedures for health, safety, and environmental compliance. He/she will drive continuous improvement throughout department to ensure most efficient use of resources to deliver value-added support; Establishes and maintains best practices, ideas and methodologies. Collaborates with all stakeholders and business partners to meet goals and objectives, identify opportunities and drive projects forward. Builds networks to maintain trust. Participates in J&J and Pharma sector initiatives related to device, combination product and emerging technologies product development and Quality Systems and other related duties as assigned by management.
Qualifications
A minimum of a Bachelor’s Degree in a scientific related field is required. A minimum of 5 years of experience in MD&D manufacturing and/or pharmaceutical, and broad scientific expertise is required. A strong device background is required. Proven experience in leading complex projects and improvement initiatives, projects and groups of professionals is required. Multifunctional background preferred. Demonstrated experience leading matrix teams required. Proficient in CTQ Flow down and Criticality Analysis methodologies is required. Demonstrated competence in the application of QRM principles as they relate to Quality by Design and current Device and Pharmaceutical Risk based process validation requirements is preferred. Experience in authoring QRM plans and Quality Risk Communication reports is preferred. Experience working in an FDA regulated industry is required. Understanding / knowledge of Quality Systems, including ISO 14971, EN 62366 and ICHQ9 Requirements is required. Knowledge of Devices, Biotech and/or Pharma Manufacturing is required, particularly in technology transfer / design transfer, Design Controls and Risk Management. Design Excellence or Six Sigma Black Best or Master Black Belt preferred. FPX Certified, CQE or CQM preferred. Excellent technical writing skills; experienced in SOPs, protocols, reports required. Versed in computing platforms such as MS Excel and Minitab are required. Experience with Cognition Cockpit is preferred. Working knowledge of Statistical Methods / Process is required.
A deep understanding of product and process development process and associated regulatory and quality requirements is required. Demonstrated systems thinking, with strong analytical, technical, problem solving and organizational skills required. The ability to communicate with Subject Matter Experts, QRM Decision Makers and other QRM Stakeholders is required. The ability to drive and conduct, if required, risk assessments and to serve as a facilitator in the use of QRM tools is required. Must understand business needs and have the ability to relate these to scientific concepts.
This position may require 25% travel, domestic and international, and could be higher at times based upon business needs.
Primary Location:North America-United States-New Jersey-Raritan
Other Locations:North America-United States-Pennsylvania-Horsham, North America-United States-Pennsylvania-Malvern, Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen, North America-United States-Pennsylvania-Spring House, North America-United States-Puerto Rico-Gurabo, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: JANSSEN SUPPLY GROUP, LLC (6046)
Job Function: Engineering (Generalist)
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement