Production Engineer – Sterile Processes

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

Job Function:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Beerse, Antwerp, Belgium

Job Description:

Production Engineer – Sterile Processes

 

About Us

At Johnson & Johnson, everyone is committed to making a difference in people's lives and pushing the boundaries of science and innovation. Our decision-making is guided by Our Credo, which challenges us to prioritize the needs and well-being of the people we serve: patients, healthcare professionals, employees, communities, and customers. With over 5,000 colleagues in Belgium, we strive for a future where disease is a thing of the past.

The Sterile Manufacturing department at Innovative Medicines Beerse aims to be a leading provider of sterile production solutions, focusing on high-quality, efficient, and compliant sterile products. To support the current portfolio and new product launches, we are seeking a dedicated Production Engineer – Sterile Processes.

 

Job Summary

As a Production Engineer in Sterile Processes, you will play a vital role in ensuring seamless, efficient, and high-quality sterile manufacturing. Your responsibilities will include process optimization, equipment performance, and strict adherence to industry standards for aseptic processing. You will collaborate closely with Maintenance, Quality, Safety, Manufacturing Science And Technology (MSAT), engineering and other teams to uphold compliance and drive continuous improvement. This is a permanent contract.

Responsibilities

• Design, develop, and optimize sterile manufacturing processes to improve throughput, compliance, and safety.
• Collaborate with cross-functional teams including MSAT, Quality, Safety, Maintenance and Engineering to support sterile product launches and ongoing process improvements.
• Ensure all processes comply with GMP, aseptic processing standards, and other regulatory requirements specific to sterile medicines.
• Implement Lean, Six Sigma, standard work, or other continuous improvement strategies to reduce waste and inefficiencies.
• Support change controls and documentation activities for sterile processes.
• Analyze production data to identify inefficiencies or non-conformances and develop corrective actions (knowledge of Power BI, Tracksys, Tableau, etc.).
• Lead investigations into sterile process deviations or contamination incidents, identifying root causes, and implementing corrective and preventive actions.
• Support the new  technology transfer of sterile manufacturing processes from development to full-scale production, ensuring processes are scalable, compliant and efficient.
• Collaborate with the validation and qualification department to set-out strategies for validation activities such as sterilization, cleaning and process qualification.

Qualifications

• Bachelor's degree or equivalent in Science, Technology, Engineering, or related fields. Master’s degree preferred.

Skills And Experience

• Familiarity with sterilization techniques, isolators, aseptic handling techniques, sterile filling and/or compounding installations.
• Understanding of regulatory requirements and industry guidelines specific to pharmaceutical and sterile manufacturing.
• Troubleshooting and resolving aseptic process deviations and contamination events. Strong problem-solving skills and analytical mindset.
• Experience with root cause analysis and CAPA.
• Ability to interpret and analyze complex environmental and process data.
• Familiarity with engineering design principles relevant to sterile equipment and systems and knowledge of equipment qualification and validation protocols. Experience with automation systems and SCADA systems, or other control systems is a plus.
• Ability to work effectively in a fast-paced, highly regulated environment.
• Excellent communication skills for cross-functional collaboration (internal and external). Strong networker.
• An innovative drive to make the difference and achieve results. Combination of analytical and technical skills to understand and solve complex issues as well as derive related business needs.
• Passionate about bringing innovative ideas, products and services to life, demonstrating strong project management and ability to manage multiple projects, change management skills and show a ‘can do’ mentality
• Flexible, can adapt to changing priorities and challenging timelines
• An individual who feels that safety and quality is of a paramount importance
• Through communicative and social skills lead to work together as a standout colleague, contributing to an energetic work environment in all levels of the organization.
• Proficient in English and Dutch