Drug Product Process Engineer, Continuous Manufacturing & Data

Johnson & Johnson is currently recruiting for a Drug Product Process Engineer, Continuous Manufacturing & Data located in Titusville, NJ; Geel, BE; or Beerse, BE!

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.

We are seeking a highly skilled and experienced Drug Product Process Engineer with expertise in continuous manufacturing, data analytics, and regulatory compliance to join our innovative team. As the Drug Product Process Engineer, you will be responsible for developing, optimizing, and ensuring the compliance of drug product manufacturing processes using continuous manufacturing techniques and for the deployment of innovation at our drug product manufacturing sites. Your knowledge of continuous manufacturing principles, data analysis, and regulatory requirements will be essential in improving process efficiency, product quality, and compliance.

Responsibilities:

• Develop and optimize drug product manufacturing processes using continuous manufacturing principles, ensuring robust and efficient operations.

• Utilize advanced data analytics techniques to monitor, analyze, and improve process performance and product quality in real-time.

• Collaborate with cross-functional teams including Research and Development, Formulation, and Quality Control to develop and implement continuous manufacturing and innovation strategies.

• Conduct data-driven process investigations and root cause analysis to identify and troubleshoot process deviations and quality issues.

• Design and execute experiments to evaluate critical process parameters and develop control strategies for drug product manufacturing.

• Stay updated on the latest regulatory requirements and guidance related to continuous manufacturing and drug product process development.

• Collaborate with equipment vendors and external partners to evaluate and select suitable continuous manufacturing technologies and equipment.

• Provide technical support and training to manufacturing personnel on continuous manufacturing processes and data analytics.

• Foster a culture of continuous improvement within the organization through data-driven decision making and process optimization.

Qualifications

Qualifications:

• Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Engineering, or a related field required; advanced degree preferred.

• 7+ years of related experience in a regulated industry; pharmaceuticals industry preferred.

• Extensive experience in drug product manufacturing with a focus on continuous manufacturing techniques required.

• Ability to work both independently and as part of a cross-functional team required.

• Attention to detail and the ability to manage multiple projects simultaneously required.

• Familiarity with PAT (Process Analytical Technology) and QbD (Quality by Design) principles is required.

• Strong knowledge of continuous manufacturing principles, methodologies, and control strategies required.

• Strong communication, collaboration, and interpersonal skills required.

• Expertise in data analysis, statistical methods, and data visualization tools for process monitoring and optimization preferred.

• Familiarity with regulatory requirements and quality standards including cGMP required; drug product manufacturing preferred.

• Proven experience in process development, scale-up, and technology transfer for drug product manufacturing preferred.

• Experience in conducting process investigations, root cause analysis, and CAPA (Corrective and Preventive Actions) implementation preferred.

• Proficiency in using data analytics software tools (e.g., JMP, R, Python) is preferred.

• Regulatory experience and knowledge of FDA/EMA regulations related to drug product manufacturing is preferred.

The anticipated base pay range for this position is $99,000 to $170,200.

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

• 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)).

• This position is eligible to participate in the Company's long-term incentive program.

• 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

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

This job posting is anticipated to close on August/30/2024. 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.

At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

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.

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.

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