Experienced Process Engineer

Johnson & Johnson is currently seeking an Experienced Process Engineer for our Large Molecule (LM) manufacturing facility in Malvern, PA!

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 are seeking a highly motivated and experienced engineer to join our team at our LM Pharmaceutical Manufacturing site. The ideal candidate will play a crucial role in the development, optimization, and operational support of drug substance manufacturing processes.

Key Responsibilities:

• Equipment Selection and Validation: Identify, evaluate, and select manufacturing equipment that meets process requirements and support the qualification and validation of its performance during implementation.
• Process Development and Optimization: Develop and refine manufacturing processes for large molecule drug substances, ensuring scalability and efficiency.
• Technical Support and Troubleshooting: Provide technical support during manufacturing operations, identifying and resolving process-related issues to ensure efficient production performance.
• Documentation and Compliance: Prepare and review process documentation, including batch records and SOPs, ensuring compliance with GMP and regulatory standards.
• Continuous Improvement Initiatives: Identify and implement process improvements to improve productivity, yield, and cost-effectiveness.
• Collaboration with Cross-Functional Teams: Work closely with teams including Quality Assurance, Quality Control, and Regulatory Affairs to ensure seamless operations and compliance.

Qualifications

Education:

• A minimum of Bachelor's degree is required, Focus degree in Engineering (Chemical Engineering, Biochemical Engineering, or a related engineering) is a plus.

Experience and Skills:

Required:

• Minimum 2 years of professional work experience in a regulated pharmaceutical or biotech industry
• Experience with Bioreactors: Proven experience in operating and optimizing bioreactors, including cell culture and fermentation systems specific to large molecule production
• Experience with Purification Equipment: Experience with chromatography systems (e.g., affinity, ion exchange, size exclusion) and/or filtration systems (e.g. ultrafiltration/diafiltration)
• Knowledge of Single-Use Technologies: Familiarity with single-use equipment and systems, including single-use bioreactors, mixers, and manifolds, and their impact on process flexibility and contamination reduction
• Understanding of P&IDs and Controlled Drawings: Proficient in reading and interpreting Piping and Instrumentation Diagrams (P&IDs) and controlled drawings to support process design and troubleshooting

Preferred:

• Equipment Validation: Familiarity with equipment qualification and validation processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
• Quality Management Systems (QMS): Experience working within quality management systems, including familiarity with deviation management, CAPA processes, and change control
• Asset Management Systems: Experience working with systems which manage equipment master data including, preventative maintenance, spare parts, equipment status

Other:

• Ability to perform tasks that may require standing for extended periods or working in controlled environments
• This position may require up to 10% domestic and international travel for training and meetings

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 (http://www.careers.jnj.com).