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&J's 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 world's 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.

The Plant Microbiologist establishes and oversees microbiological control and assurance programs within the operations department and manages activities in compliance with corporate, cGMP, EHS, and other regulatory requirements. Practice proactive environmental monitoring oversight, participate and consult on investigations and risk assessments and promote a culture of continuous improvement and open communication.

This position designs and delivers the training program, to ensure a high standard of aseptic awareness and compliance, on the operations floor.

It is responsible for reviewing and designing new facilities or modifying existing facilities designing new equipment or modifying existing equipment and be involved in any changes to the facility, gowning, cleaning, production process, production equipment, sampling and testing related to microbiological control or aseptic handling. Collaborate with Microbiologists across the Biologics API manufacturing facilities and appropriate external industry groups, leveraging knowledge and expertise resident throughout the Johnson and Johnson family of companies to establish and maintain a robust contamination control culture. Provide technical assistance to ensure business, quality and compliance goals are met following the J&J Standard of Leadership behavior model.

Key Responsibilities:

• Lead by example and striving to perform to high standards at all times in compliance with Credo and Standards of leadership.
• Manage all activities in compliance with corporate, cGMP, EHS, and other regulatory requirements.
• Provide leadership by actively leading / supporting process microbiology investigations.
• Identify and drive strategy improvements related to the reduction of contamination risks and the improvement of microbiological hygiene through the promotion of a culture of continuous improvement and open communication.
• Perform Risk Assessments for manufacturing projects and business innovation initiatives
• Define specific aseptic techniques to be performed for crucial process steps
• Provide effective and timely communication of any adverse trends or activities as appropriate.
• Achieve goals through internal and cross functional collaboration
• Collaborate with Process Microbiologists across the JNJ network
• Reviewing and approving relevant SOP's and WI's.
• Anticipate and participate in the planning for future requirements in Operations.
• Ensures microbiological control strategy is consistent with GMP requirements and company requirements.
• Participate in relevant internal and external manufacturing related audits.
• Understand and support current regulatory trends and future testing requirements.
• Deputize for Plant Microbiologist, as required
• Travel to JSC, J&J and other external sites as required for meetings, training etc.

Qualifications

Required:

• A minimum of a B.S. degree in a scientific/technical discipline.
• A minimum of 8 years of experience in aseptic technique within bioprocessing
• Experience as a plant/process microbiologist within Life Sciences or Biopharmaceutical manufacturing.
• Promote a culture of continuous improvement, innovation, and adaptability, challenging the status quo to drive positive change.
• Leverage excellent verbal and written communication skills in English, with strong interpersonal abilities to build productive relationships and collaborate effectively within teams.
• Provide strong leadership by mentoring colleagues and serving as a strategic partner across departments.
• Demonstrate expertise in crisis, project, change, knowledge, and data management, with a focus on technology, quality, compliance, analytics, and problem-solving.
• Develop business cases to support continuous improvement initiatives across operations.
• In-depth knowledge of FDA/EMEA regulatory requirements for biologics and pharmaceuticals.
• Uphold high ethical standards and integrity, ensuring Credo-based actions.
• Foster productive relationships within teams, treating all individuals with dignity and respect.
• Take accountability for the compliant and flawless execution of tasks.
• Thrive in a multi-cultural, matrixed environment with cultural sensitivity.
• Adapt to a dynamic supply chain environment with flexibility and a focus on organizational development.

Preferred:

• Business Excellence and Problem-Solving skills Qualifications e.g. Six Sigma, Lean Green/Black Belt or Kepner-Tregoe analysis.
• Advanced degree (MS, MBA, PhD)

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 Company's 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.