Johnson & Johnson companies are equal opportunity employers.
SR. DIRECTOR ASEPTIC PROCESSING-1647121203
Description
Johnson & Johnson is recruiting for a Senior Director Aseptic Processing for Raritan, NJ.
Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Senior Director Aseptic Processing influences the company's strategic and tactical directions and financial results through the application of technical knowledge and expertise in aseptic processing for Pharma, Biologic and Combination products.
The Senior Director Aseptic Processing directs compliance and risk based evaluations and provides in-depth technical support for new sterile products and aseptic processes, technology concepts and process development and validation activities. Provides input or approval for facility, equipment and process design specifications, qualifications, validations and control programs. Proposes solutions and pushes the organization to resolve difficult problems and address knowledge and/or resource gaps. Provides direction on quality and compliance requirements that satisfies global regulatory requirements and cGMP expectations. Plays a strategic leadership role in providing technical support for process changes, new or modified aseptic processing facilities, failure investigations and root cause analyses. Assist in readiness reviews in advance of regulatory agency inspections, as well as responding to regulatory citations and other enforcement actions. Advocates for the implementation of innovative quality risk management and QbD programs and assists in due diligence and on-site technical assessments. Represents J&J at key industry standards organizations and influences regulations and standards. Develops J&J Enterprise-wide technical standards and guidance documents on aseptic processing and controlled bioburden manufacturing operations. Delivers world class training and sets the curriculum for aseptic processing training globally. Leads and manages talent and implements training and development initiatives to optimize staff skills. Oversees the Sterility Assurance support provided to the manufacture of products that are aseptically manufactured.
Qualifications
Individual must have an undergraduate degree in Engineering or Microbiology/Biology or closely related discipline with a minimum of 20 years related experience is required. An advanced degree is preferred. The candidate will have hands on experience in aseptic processing operations. Prior experience participating at a high level and/or leading industry standards working group(s) in the area of Aseptic Processing would be desired. Demonstrated expertise through authored multiple peer reviewed publications is a plus. It is also desired that the successful candidate exhibit high level skills in risk assessments and the design of experiments/validation. A proven track record on trouble shooting process non-conformances and out of specification test results and providing resolution to issues via robust CAPA is a requirement. Demonstrated experience conducting audits of in-house and contract aseptic processing required. Individual must have demonstrated capability to lead and train a large diverse, multinational community with multiple stakeholders, working in a supervisory, coaching, mentoring and/or influencing capacity. The candidate must have demonstrated ability to act as a subject matter expert in the area of Aseptic Processing on behalf of the organization both internally and externally on industry standards association such as AAMI, PDA, etc. This position will typically require up to 30% domestic and International travel, but may be higher depending on business need.
It is preferred that this position will be located in Raritan, NJ, USA.
BE VITAL in your career; Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
J2W:BIO
J2W:NSJ
J2W:MZ
Primary Location:North America-United States-New Jersey-Raritan
Organization: Johnson & Johnson International (6078)
Job Function: R&D Engineering (R&D)
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
SR. DIRECTOR ASEPTIC PROCESSING-1647121203
Description
Johnson & Johnson is recruiting for a Senior Director Aseptic Processing for Raritan, NJ.
Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Senior Director Aseptic Processing influences the company's strategic and tactical directions and financial results through the application of technical knowledge and expertise in aseptic processing for Pharma, Biologic and Combination products.
The Senior Director Aseptic Processing directs compliance and risk based evaluations and provides in-depth technical support for new sterile products and aseptic processes, technology concepts and process development and validation activities. Provides input or approval for facility, equipment and process design specifications, qualifications, validations and control programs. Proposes solutions and pushes the organization to resolve difficult problems and address knowledge and/or resource gaps. Provides direction on quality and compliance requirements that satisfies global regulatory requirements and cGMP expectations. Plays a strategic leadership role in providing technical support for process changes, new or modified aseptic processing facilities, failure investigations and root cause analyses. Assist in readiness reviews in advance of regulatory agency inspections, as well as responding to regulatory citations and other enforcement actions. Advocates for the implementation of innovative quality risk management and QbD programs and assists in due diligence and on-site technical assessments. Represents J&J at key industry standards organizations and influences regulations and standards. Develops J&J Enterprise-wide technical standards and guidance documents on aseptic processing and controlled bioburden manufacturing operations. Delivers world class training and sets the curriculum for aseptic processing training globally. Leads and manages talent and implements training and development initiatives to optimize staff skills. Oversees the Sterility Assurance support provided to the manufacture of products that are aseptically manufactured.
Qualifications
Individual must have an undergraduate degree in Engineering or Microbiology/Biology or closely related discipline with a minimum of 20 years related experience is required. An advanced degree is preferred. The candidate will have hands on experience in aseptic processing operations. Prior experience participating at a high level and/or leading industry standards working group(s) in the area of Aseptic Processing would be desired. Demonstrated expertise through authored multiple peer reviewed publications is a plus. It is also desired that the successful candidate exhibit high level skills in risk assessments and the design of experiments/validation. A proven track record on trouble shooting process non-conformances and out of specification test results and providing resolution to issues via robust CAPA is a requirement. Demonstrated experience conducting audits of in-house and contract aseptic processing required. Individual must have demonstrated capability to lead and train a large diverse, multinational community with multiple stakeholders, working in a supervisory, coaching, mentoring and/or influencing capacity. The candidate must have demonstrated ability to act as a subject matter expert in the area of Aseptic Processing on behalf of the organization both internally and externally on industry standards association such as AAMI, PDA, etc. This position will typically require up to 30% domestic and International travel, but may be higher depending on business need.
It is preferred that this position will be located in Raritan, NJ, USA.
BE VITAL in your career; Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
J2W:BIO
J2W:NSJ
J2W:MZ
Primary Location:North America-United States-New Jersey-Raritan
Organization: Johnson & Johnson International (6078)
Job Function: R&D Engineering (R&D)
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