Pilot Plant Quality and Compliance Engineer

Biopharma Asia; Antwerpen; Hybrid; EUR 60,000 - 96,000; Full time

Benefits offered by this job

Hospital insurance

Healthcare-related benefits

Job summary

Johnson & Johnson in Belgium seeks a Pilot Plant Quality and Compliance Engineer to support day-to-day operations, deviations investigations, and regulatory compliance across Beerse and Geel pilot plants. You will lead cleaning validation, responsible for cross-functional actions, and work with quality, operations and engineering teams.

This two-year term role offers exposure to multi-product processes, GMP environments, and ongoing process improvements within Innovative Medicine and MedTech.

Qualifications

• PhD or master's in chemistry, chemical engineering, or related pharma field.
• GMP knowledge and ICH Q7 familiarity are assets.
• Understanding of process safety, pilot plant operations, process development, and engineering.
• Strong analytical and problem-solving capabilities.
• Ability to challenge practices and identify improvements.
• Strong communication and collaboration skills.
• Project management and ability to manage multiple priorities.

Responsibilities

• Support pilot plant operations and timely release of clinical batches and equipment.
• Coordinate and document deviation investigations.
• Facilitate root-cause analysis and define corrective and preventive actions.
• Assess impact of deviations on product quality and regulatory compliance.
• Support cleaning-limit calculations, cleaning validation, and improvement of cleaning methods.
• Implement projects to maintain compliance of pilot plant systems with evolving regulatory requirements.
• Contribute to lifecycle-management activities for systems including deviation management, equipment qualification, cleaning validation, and contamination control.
• Work closely with operations, engineering, maintenance, and Quality Assurance.

Skills

Analytical skills

Problem solving

Communication & collaboration

Multitasking & project management

Education

PhD or MSc in Chemistry / Chemical Engineering

Tools

GMP knowledge

ICH Q7 knowledge

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

R&D Product Development

Job Sub Function:

R&D Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Beerse, Antwerp, Belgium, Geel, Antwerp, Belgium

Job Description:

Johnson & Johnson Innovative Medicine develops innovative therapies that address unmet medical needs through science and technology.

The Chemical Process Research and Development (CPRD) department is looking for a Pilot Plant Quality and Compliance Engineer to join its team in Belgium.

CPRD operates three chemical pilot plants in Beerse and Geel. These facilities develop and scale up chemical processes and manufacture active pharmaceutical ingredients (APIs) for clinical trials. The Chemical Development Pilot Plant in Geel also supports the launch of new, low-volume commercial products. Our pilot plants continuously invest in technology, automation, and data capabilities to prepare for future products and evolving manufacturing requirements.

The Role

As a Quality and Compliance Engineer, you support day-to-day pilot plant operations in close collaboration with operations personnel, process engineers, maintenance teams, and Quality Assurance.

Deviations may occur during the manufacture of experimental drug substances because of process- or equipment-related issues. You coordinate cross-functional investigations to identify root causes, define corrective and preventive actions, and assess the potential impact on product quality and regulatory compliance. You also ensure that investigations are documented in accordance with established standards and are ready for review by health authorities.

Because the pilot plants use multiproduct equipment, robust cleaning processes are essential to prevent cross-contamination. Your responsibilities therefore also include establishing cleaning limits and supporting the validation and continuous improvement of cleaning methods.

You report to the Pilot Plant Quality and Compliance Lead and apply a phase-appropriate quality approach that reflects the product’s development stage and the available process and product knowledge.

This role is limited to two-year term.

Your Responsibilities

• Support pilot plant operations and the timely release of clinical batches and equipment.
• Coordinate and document deviation investigations.
• Facilitate root-cause analysis and the definition of corrective and preventive actions.
• Assess the impact of deviations on product quality and regulatory compliance.
• Support cleaning-limit calculations, cleaning validation, and the improvement of cleaning methods.
• Implement projects that maintain the compliance of pilot plant systems with evolving regulatory requirements.
• Contribute to lifecycle-management activities for systems including deviation management, equipment qualification, cleaning validation, and contamination control.
• Work closely with operations, engineering, maintenance, and Quality Assurance.

Qualifications and Skills

• A PhD or master’s degree in chemistry, chemical engineering, or a related field, or relevant experience in the pharmaceutical industry.
• Practical knowledge of current Good Manufacturing Practices and ICH Q7 is an asset.
• Understanding of process safety, pilot plant operations, process development, and engineering.
• Strong analytical and problem-solving skills.
• Ability to challenge existing practices and identify improvement opportunities.
• Strong communication and collaboration skills.
• Project-management skills and the ability to manage several priorities simultaneously.

Working in Belgium

Johnson & Johnson’s Belgian campus brings together approximately 5,000 employees and capabilities spanning the full drug-development lifecycle, from discovery through market access. This integrated environment offers broad opportunities to learn, collaborate, and build experience across different areas of drug development.

Our Offer

• A challenging role in an international and dynamic environment.
• Continuous learning and career-development opportunities.
• An attractive remuneration and benefits package, including hospital insurance and healthcare-related benefits.
• An inclusive workplace where different perspectives are respected and valued.
• A work environment that supports a healthy work-life balance.

The anticipated base pay range for this position is:

€60.000,00 - €96.255,00

Benefits:

• In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.