Drug Product Process Engineer

Description

Johnson & Johnson is currently recruiting for a Drug Product Process Engineer!

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/.

Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity!

We are seeking a highly skilled and experienced 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 manufacturing processes using continuous manufacturing techniques and for the deployment of innovation at our manufacturing sites. Your knowledge of continuous manufacturing principles, data analysis, and regulatory requirements will be critical in improving process efficiency, product quality, and compliance.

Responsibilities:

• Develop and optimize small molecule drug product manufacturing processes using continuous manufacturing principles, ensuring robust and efficient operations.
• Apply 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 innovation strategies.
• Design and complete experiments to evaluate critical process parameters and develop control strategies for small molecule drug product manufacturing.
• Stay updated on the latest regulatory requirements and guidance related to continuous manufacturing and 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 small molecule continuous manufacturing processes and data analytics.
• Champion a culture of continuous improvement within the organization through data-driven decision making and process optimization.

Qualifications

Education:

• Minimum of a Bachelor’s degree or equivalent University Degree in Chemical Engineering, Pharmaceutical Engineering, or a related field is required; Master’s degree or advanced degree is preferred

Experience and Skills

Required:

• Minimum 6 years of related experience in a regulated industry; pharmaceuticals preferred
• Experience in small molecule drug product manufacturing with a focus on continuous manufacturing techniques
• Familiarity with regulatory requirements and quality standards including cGMP
• Familiarity with PAT (Process Analytical Technology) and QbD (Quality by Design) principles
• Strong knowledge of continuous manufacturing principles, methodologies, and control strategies
• Ability to work both independently and as part of a multi-functional team
• Attention to detail and the ability to manage multiple projects simultaneously
• Strong communication, collaboration, and interpersonal skills

Preferred:

• Expertise in data analysis, statistical methods, and data visualization tools for process monitoring and optimization
• Proven experience in process development, scale-up, and technology transfer for drug product manufacturing
• Experience in conducting process investigations, root cause analysis, and CAPA (Corrective and Preventive Actions) implementation.
• Proficiency in using data analytics software tools (e.g., JMP, R, Python)
• Regulatory experience and knowledge of FDA/EMA regulations related to drug product manufacturing

Other:

• This position may require up to 10% domestic & international travel
• Requires the ability, through our flexible work policy, to work on-site a minimum of three days each week, with the option for two remote workdays each week

Why join Johnson & Johnson?

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

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 are eligible for the following time off benefits:

• 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 of 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.

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."

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.