Johnson & Johnson
Staff MSAT Engineer
Johnson & Johnson, Wilson, North Carolina, United States, 27893
Description
Johnson & Johnson is currently seeking a Staff MSAT Engineer to join our Johnson & Johnson Innovative Medicine Supply Chain organization located in Wilson, North Carolina. This position may require up to 25% travel in the startup phase.
This role may require periods of increased travel to support startup activities based on functional needs and project timelines. In some cases, this could involve frequent travel and/or short-term stays with vendors, sister companies, or partners. In steady state, we expect travel to be
Manufacturing Science and Technology (MSAT) manages the process technology platform strategy for the production of biotherapeutics in the new BioProcessing Facility located in Wilson, North Carolina. We are responsible for Process & Cleaning Validation, Standardization of Equipment for New Product Introduction, and Life Cycle Management (LCM) of our commercial production processes.
As a Staff MSAT Engineer, you will be responsible for the following:
Leading MSAT Thermal Validation activities for the startup of a new site, which will include developing strategies/ master plans, resource profile, and budget estimates for MSAT validation activities.
Delivering successful outcomes to all MSAT thermal validation activities using Good Manufacturing Practices (GMP) and tracking execution through appropriate KPI’s.
Leading and/or providing technical guidance for process improvement projects and investigations.
Secondary activities include, but are not limited to, Cleaning Validation, Process Validation Support (e.g., Mixing Studies, Microbial Hold Studies, Media Challenges), Supporting process improvement projects, Supporting New product Introduction/ process validation, GMP documentation generation, and investigations.
Primary tasks:
Lead / Conduct MSAT activities in compliance with US and EU regulations, J&J Global procedures, and EHS&S requirements.
Develop MSAT Validation strategies, plans, protocols, procedures, reports, and co-ordinate document review and approval.
Execute MSAT protocols as required and prepare reports for executed protocols for review and approval.
Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.
Initiate and implement change control activities in accordance with site procedures.
Track and resolve exceptions/events/deviations during MSAT activities.
Prioritize MSAT activities in line with the project schedule.
Co-ordinate MSAT activities with engineering, construction and commissioning activities and with contractors and vendors as required.
Collate and organize MSAT files for turnover to QADC.
Attend identified training, required to fulfill the role of an MSAT Principal Engineer and assist in the development of training material for MSAT activities.
Participate in cross-functional teams as required.
Deputize for the MSAT Lead or other team members where required.
Domestic and international travel may be required.
Leadership responsibilities / individual contribution:
Empower MSAT team members through technical leadership, innovation, and change.
Drive a Credo-based culture aligned with our guiding principles of Leadership Imperatives and Vital Behaviors.
Provide coaching and support development opportunities for team members.
Partner with global innovation teams, build cross-site relationships, exchange lessons learned, and align activities.
Qualifications
Required:
Bachelor’s degree or equivalent in Science or Engineering (Biomedical, Biochemical, Chemical Technology, Biotechnology, Pharmacy, (biological) Engineering; Life Science Technology) with a minimum of 8 years of relevant experience.
OR
MS/MBA/Ph.D. or equivalent with a minimum of 6 years of relevant experience.
Excellent written and oral communication skills and ability to influence peers, senior leadership, and partners is required.
Preferred:
Knowledge of Pharmaceutical Manufacturing, with experience in Large Molecules and/or Parenteral products.
Proven leadership and ability to integrate activities and information across multifunctional teams.
Strong collaboration skills to foster team productivity and cohesiveness, with a focus on delivering results in project/matrix environments.
Training in 6-Sigma, Lean, or similar problem-solving and decision-making methodologies.
This job posting is anticipated to close on X/XX/24. The Company may however extend this time-period, in which case the posting will remain available on
https://www.careers.jnj.com
to accept additional applications.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit
www.careers.jnj.com .
Primary LocationNA-US-North Carolina-Wilson
Other LocationsJohnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
#J-18808-Ljbffr
Johnson & Johnson is currently seeking a Staff MSAT Engineer to join our Johnson & Johnson Innovative Medicine Supply Chain organization located in Wilson, North Carolina. This position may require up to 25% travel in the startup phase.
This role may require periods of increased travel to support startup activities based on functional needs and project timelines. In some cases, this could involve frequent travel and/or short-term stays with vendors, sister companies, or partners. In steady state, we expect travel to be
Manufacturing Science and Technology (MSAT) manages the process technology platform strategy for the production of biotherapeutics in the new BioProcessing Facility located in Wilson, North Carolina. We are responsible for Process & Cleaning Validation, Standardization of Equipment for New Product Introduction, and Life Cycle Management (LCM) of our commercial production processes.
As a Staff MSAT Engineer, you will be responsible for the following:
Leading MSAT Thermal Validation activities for the startup of a new site, which will include developing strategies/ master plans, resource profile, and budget estimates for MSAT validation activities.
Delivering successful outcomes to all MSAT thermal validation activities using Good Manufacturing Practices (GMP) and tracking execution through appropriate KPI’s.
Leading and/or providing technical guidance for process improvement projects and investigations.
Secondary activities include, but are not limited to, Cleaning Validation, Process Validation Support (e.g., Mixing Studies, Microbial Hold Studies, Media Challenges), Supporting process improvement projects, Supporting New product Introduction/ process validation, GMP documentation generation, and investigations.
Primary tasks:
Lead / Conduct MSAT activities in compliance with US and EU regulations, J&J Global procedures, and EHS&S requirements.
Develop MSAT Validation strategies, plans, protocols, procedures, reports, and co-ordinate document review and approval.
Execute MSAT protocols as required and prepare reports for executed protocols for review and approval.
Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.
Initiate and implement change control activities in accordance with site procedures.
Track and resolve exceptions/events/deviations during MSAT activities.
Prioritize MSAT activities in line with the project schedule.
Co-ordinate MSAT activities with engineering, construction and commissioning activities and with contractors and vendors as required.
Collate and organize MSAT files for turnover to QADC.
Attend identified training, required to fulfill the role of an MSAT Principal Engineer and assist in the development of training material for MSAT activities.
Participate in cross-functional teams as required.
Deputize for the MSAT Lead or other team members where required.
Domestic and international travel may be required.
Leadership responsibilities / individual contribution:
Empower MSAT team members through technical leadership, innovation, and change.
Drive a Credo-based culture aligned with our guiding principles of Leadership Imperatives and Vital Behaviors.
Provide coaching and support development opportunities for team members.
Partner with global innovation teams, build cross-site relationships, exchange lessons learned, and align activities.
Qualifications
Required:
Bachelor’s degree or equivalent in Science or Engineering (Biomedical, Biochemical, Chemical Technology, Biotechnology, Pharmacy, (biological) Engineering; Life Science Technology) with a minimum of 8 years of relevant experience.
OR
MS/MBA/Ph.D. or equivalent with a minimum of 6 years of relevant experience.
Excellent written and oral communication skills and ability to influence peers, senior leadership, and partners is required.
Preferred:
Knowledge of Pharmaceutical Manufacturing, with experience in Large Molecules and/or Parenteral products.
Proven leadership and ability to integrate activities and information across multifunctional teams.
Strong collaboration skills to foster team productivity and cohesiveness, with a focus on delivering results in project/matrix environments.
Training in 6-Sigma, Lean, or similar problem-solving and decision-making methodologies.
This job posting is anticipated to close on X/XX/24. The Company may however extend this time-period, in which case the posting will remain available on
https://www.careers.jnj.com
to accept additional applications.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit
www.careers.jnj.com .
Primary LocationNA-US-North Carolina-Wilson
Other LocationsJohnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
#J-18808-Ljbffr