Principal MSAT Engineer

Principal MSAT Engineer – 2406210999W

Description

Johnson & Johnson is currently seeking a Principal MSAT Engineer to join our Manufacturing Science and Technology team located in Wilson, NC.

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 <10%.

J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&Js significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the worlds most pressing healthcare challenges.

We know that the success of our business and our ability to deliver meaningful solutions depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

Manufacturing Science and Technology (MSAT) manages the process technology platform strategy for the production of biotherapeutics in the new BioProcessing Facility 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 Principal MSAT Engineer you will be responsible for the following:

Leading MSAT Cleaning 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 outcome to all MSAT cleaning validation activities using Good Manufacturing Practices (GMP) and tracking execution through appropriate KPIs. Leading and/or providing technical guidance for process improvement projects and investigations.

Secondary activities include, but are not limited to, Thermal 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 another team member 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:

Bachelors 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

Preferred:

Knowledge of Pharmaceutical Manufacturing, with experience in Large Molecules and/or Parenteral products.

Proven leadership and ability to influence and integrate activities and information across multifunctional teams.

Strong team-building skills with a focus on collaboration to drive productivity and achieve results within project/matrix teams.

Training in 6-Sigma, Lean, or similar problem-solving and decision-making methodologies.

This job posting is anticipated to close on 10/20/2024. 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.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

Vacation up to 120 hours per calendar year

Sick time – up to 40 hours per calendar year; for employees who reside in the State of Washington up to 56 hours per calendar year

Holiday pay, including Floating Holidays up to 13 days per calendar year

Work, Personal and Family Time – up to 40 hours per calendar year

Additional information can be found through the link below.

For additional general information on Company benefits, please go to: – https://www.careers.jnj.com/employee-benefits

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 Location NA-US-North Carolina-Wilson

Other Locations NA-US-North Carolina-Raleigh, NA-US-North Carolina-Goldsboro, NA-US-Pennsylvania-Horsham, NA-US-Pennsylvania-Philadelphia, NA-US-North Carolina-Greenville, NA-US-North Carolina-Rocky Mount

Organization Janssen Biotech, Inc. (6014)

Relocation Eligible: Yes – Within Country

Job Function R&D Process Engineering

Req ID: 2406210999W