Senior Project Engineer Commissioning & Qualification

Johnson & Johnson Innovative Medicine; Geel; On-site; EUR 73,000 - 115,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Job summary

Johnson & Johnson Innovative Medicine in Geel/Beerse, Belgium, is seeking a Senior C&Q Engineer to lead end-to-end qualification for Atlas process equipment within GET. You will coordinate deliverables and partner with cross-functional teams to ensure compliance and timely project outcomes.

The role requires deep FDA/EMA qualification knowledge, hands-on project experience, and strong communication skills. Dutch and English proficiency are essential, with a Master’s in Engineering or Science and

Qualifications

• FDA/EMA equipment qualification knowledge and standards (ICH Q7, ISPE C&Q, GAMP 5, ASTM E2500).
• Hands-on experience leading commissioning and qualification activities.
• Strong communication and collaboration skills across teams.
• Proficient in Dutch and English.

Responsibilities

• End-to-end ownership of Atlas equipment qualification strategy.
• Define and review qualification deliverables (PV plan, URs, risk & impact assessments, DQ/IQ/OQ/PQ, Quality Summary).
• Coordinate qualification activities with external Architect/Engineer partner.
• Apply risk-based qualification per internal standards and regulatory expectations.
• Partner with Process Engineering, Automation, Technical Safety, Maintenance, MSAT, Operations, and QA.
• Manage risks, deviations and remediation related to Atlas equipment qualification.
• Act as SME for the KNEAT digital validation tool.
• Represent the company in regulatory inspections and client audits.
• Participate in J&J community of practice for risk-based qualification.

Skills

QA standards

Commissioning

Communication skills

Languages: Dutch/English

Education

Master’s degree in Engineering or Science

Tools

KNEAT

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

Supply Chain Engineering

Job Sub Function

Quality Engineering

Job Category

Scientific/Technology

All Job Posting Locations:

Geel, Antwerp, Belgium

Job Description

Johnson & Johnson is recruiting for a Senior C&Q Engineer within Global Engineering and Technology (GET) in Geel/Beerse, Belgium.

Our Commercial API (Active Pharmaceutical Ingredient) Plants at the Geel site, together with our Chemical Development Plants in Geel and Beerse, are important in driving forward the development of new medicines. Our primary goal is to ensure the safe, efficient, and competitive delivery of lifesaving medications to patients at all times. In addition to scaling up Active Pharmaceutical Ingredients (APIs) from lab scale to commercial production, the pilot plants and commercial plants also play a significant role in supplying medicines necessary for vital clinical studies before a product launch. To fulfil our mission, we consistently invest in groundbreaking technologies, dedicated individuals, and strategic partnerships.

Our teams work together in a dynamic environment where your contributions will be valued, and you’ll collaborate with hardworking colleagues who share a ‘can-do’ mentality.

Key Responsibilities

As a C&Q Engineer, your primary objective is to be accountable end to end within GET for the C&Q aspects of Atlas process equipment. ATLAS is a strategic capacity expansion at the Geel site. It includes the replacement and expansion of reactors; the installation of centrifuges, dryers, and filter dryers; and the utility and infrastructure modifications needed within existing production buildings. The new multipurpose installations will increase operational flexibility, support future demand, and meet evolving compliance expectations.

Your Role Will Include

• End-to-end ownership of qualification strategy for Atlas process equipment.
• Define and review qualification deliverables (Project Validation Plan, User Requirements, Risk Assessment, Impact Assessment, DQ/IQ/OQ/PQ protocols, Quality Summary Report, etc.).
• Coordinate qualification activities delivered by the A/E partner (Architect/Engineer partner, the external engineering contractor responsible for design and engineering execution).
• Guide project teams in applying risk-based qualification in alignment with our internal standards, quality requirements, and regulatory expectations.
• Partner with Process Engineering, Automation, Technical Safety, Maintenance, MSAT, Operations, and QA.
• Manage risks, deviations, and remediation activities related to Atlas equipment qualification.
• Act as an SME for the digital validation tool (KNEAT).
• Act as a spokesperson during regulatory inspections and client audits, including audit preparation.
• Be an active member of the J&J community of practice for the risk-based qualification approach.

Qualifications, Experience, And Skills

• Deep understanding of FDA and EMA equipment qualification requirements and industry standards such as ICH Q7, ISPE C&Q guidelines, GAMP 5, and ASTM E2500.
• Preferably, hands-on experience leading the execution of commissioning and qualification activities in projects.
• Strong communication and interpersonal skills, with the ability to collaborate effectively and contribute to an energetic work environment at all levels of the organization.
• Proficient in Dutch (or willing to learn Dutch) and English.
• A master’s degree, or equivalent experience, preferably in Engineering or Science.

What You Can Expect From Us

Employees are vital to our organization. You will be part of an enthusiastic team in an innovative environment that values personal and professional development. In this role, you will have the potential to transform both our business and your career. We encourage you to think big and go after your goals. Through on-the-job training, e-learning, and various projects and programs, we support your personal growth by focusing on your talents and empowering you to take control of your career and where it leads you.

#SCEngineer

The Anticipated Base Pay Range For This Position Is

€72,500.00 - €115,230.00

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.