Senior Quality Engineer (Qualification & Validation – Equipment & Facilities)

Location: Courcelles, Hainaut, Belgium

Remote Type: Hybrid Work

Time Type: Full time

Job Description

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 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.

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Lead Quality – Qualification & Validation (Distribution Center)
Location: Courcelles (EMEA) — Hybrid (3 days onsite / 2 days remote)
Contract: CDI / permanent contract

Join a high‑impact Quality team at a global MedTech leader and own the technical delivery of equipment qualification & validation at a strategic European Distribution Center. This is a hands‑on, visible role where your expertise in IQ/OQ/PQ, process qualification and operational quality will directly improve patient safety, reduce regulatory risk and raise operational excellence across repack/relabel and distribution activities.

What you will do (core responsibilities)

• Lead and coordinate qualification, validation and calibration activities for equipment and facilities used in distribution and repack/relabel operations (new equipment qualification and periodic re‑qualification).

• Act as the operational Quality expert on the floor: Gemba walks, weekly operational kick‑offs and direct coaching of warehouse teams.

• Drive and follow up internal & external audits and inspections; perform proactive gap analyses and implement CAPAs to secure business continuity.

• Own Change Control activities related to DC and repackaging processes and ensure robust documentation and approvals.

• Maintain and improve QMS elements: SOPs, Work Instructions, document control, training, CAPA, investigations and KPI tracking.

• Analyze NC/CAPA and delivery service trends, propose corrective/preventive actions and feed the Quality Improvement Plan (QIP) and Quality System Management Review (QSMR).

• Participate in cross‑functional projects (new equipment, process automation), ensuring validation and regulatory requirements are met. 

• Identify, assess and mitigate quality risks tied to QA and operational processes.

Who we are looking for (must‑have profile)

• Proven experience in a regulated environment (pharmaceuticals, medical devices or healthcare operations) with a clear focus on QUALIFICATION & VALIDATION of equipment and facilities.

• Demonstrated track record executing IQ/OQ/PQ protocols, preparing validation dossiers and leading equipment requalification programs.

• Strong knowledge of quality system processes: Change Control, CAPA, Investigations, Document Management, Training and Audit.

• Familiarity with GDP/GMP requirements and ISO 13485.

• Analytical mindset, risk‑based approach, excellent written & verbal communication, ability to influence cross‑functional stakeholders.

• Able to work independently, organize priorities and escalate appropriately.

Technical tools & experience (advantageous)

• Experience with JDE, ETQ (or equivalent QMS), Windchill, Summit or similar systems.

• Strong Excel and Microsoft Office skills.

• Lean/process improvement experience is valued.

Languages

• English only is sufficient to apply.

• French is a strong advantage (local interactions & documentation).

Remuneration & benefits

• Indicative base salary: €60,000 – € 96,255 gross per year (depending on experience).

• Comprehensive J&J benefits package: performance bonuses, health and pension benefits, local employee benefits (e.g., meal vouchers / mobility allowances where applicable / internet allowance /eco-cheques / leisure cheques).

• Career development and international mobility opportunities within the EMEA network.

Working arrangement

• Hybrid: 3 days onsite at Courcelles / 2 days remote per week.

• Close collaboration with Operations, Supply Chain and EMEA Deliver teams.

Why join us 

• High visibility role with direct impact on compliance, safety and operational efficiency.

• Blend of technical validation work, process ownership and cross‑functional project delivery.

• Opportunity to shape best practices on Qualification and Validation processes

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