Quality Manufacturing Engineer

Real; Groningen; On-site; EUR 60,000 - 90,000; Full time

Job summary

Johnson & Johnson Innovative Medicine is seeking a hands-on Quality Manufacturing Engineer to support Groningen shopfloor operations. You will act as the quality representative on the production floor, partnering with Operations and Manufacturing Engineering to ensure compliance, investigate quality events, and drive continuous improvement.

This role involves managing deviations, non-conformities, CAPAs and change controls within a highly regulated pharmaceutical manufacturing environment.

Qualifications

• Minimum 5 years of relevant work experience.
• Quality experience within a manufacturing environment.
• Experience in regulated industries (Pharma/Medical Device/GMP) is preferred.
• Strong knowledge of Deviations, CAPAs, Change Control, GMP.
• Professional English communication.
• Ability to read and understand Dutch manufacturing documentation.

Responsibilities

• Provide day-to-day quality oversight to manufacturing operations.
• Investigate and manage deviations and non-conformities.
• Support planned deviations from established manufacturing processes.
• Coordinate and manage internal quality escalations.
• Review and approve production process changes per GMP requirements.
• Lead root cause investigations and CAPA activities.
• Analyse manufacturing reject and deviation trends for continuous improvement.
• Ensure compliance with quality standards, regulatory requirements and site procedures.
• Communicate quality risks, trends and improvements to management and cross-functional teams.
• Support SOPs and manufacturing documentation revision and optimisation.
• Drive initiatives to improve product quality and reduce process variation.

Skills

Quality oversight

CAPA management

GMP knowledge

Root cause analysis

Shopfloor collaboration

Regulatory compliance

Stakeholder management

English proficiency

Job description

Location | Contract | Languages

• Location: Groningen, The Netherlands
• Contract: 12 Months
• Work Model: 100% onsite
• Interview Process: Onsite interview required
• Languages: Dutch (reading and understanding required) and English

About the Role

At Johnson & Johnson Innovative Medicine, quality is at the heart of everything we do. We are looking for a hands-on Quality Manufacturing Engineer to support manufacturing operations on the shopfloor in Groningen.

In this role, you will act as the quality representative within production, working closely with Operations and Manufacturing Engineering to ensure compliance, investigate quality events, and drive continuous improvement. You will play a key role in managing deviations, non-conformities, CAPAs, and change controls within a highly regulated pharmaceutical manufacturing environment.

This opportunity is ideal for someone who enjoys being close to the operation, partnering with production teams, and solving quality challenges where they occur: on the shopfloor.

What You'll Do

• Provide day-to-day quality oversight and support to manufacturing operations.
• Investigate and manage deviations and non-conformities within production.
• Support and guide planned deviations from established manufacturing processes.
• Coordinate and manage internal quality escalations.
• Review and approve production process changes in accordance with GMP requirements and internal procedures.
• Lead and support root cause investigations and CAPA activities.
• Analyse manufacturing reject and deviation trends to identify continuous improvement opportunities.
• Ensure compliance with quality standards, regulatory requirements, and site procedures.
• Communicate quality risks, trends, and improvement opportunities to management and cross-functional teams.
• Support the development, revision, and optimisation of SOPs and manufacturing documentation.
• Drive initiatives focused on improving product quality and reducing process variation.

What You'll Bring

• Minimum 5 years of relevant work experience.
• Quality experience within a manufacturing environment.
• Experience working in a highly regulated industry such as Pharmaceutical, Medical Device, Biotechnology, or GMP-regulated manufacturing.
• Strong knowledge of:
• Deviations
• CAPAs
• Change Control
• GMP requirements
• Comfortable working directly with operators and production teams on the shopfloor.
• Strong communication and stakeholder management skills.
• Ability to work independently while collaborating effectively with multidisciplinary teams.
• Professional English communication skills.
• Ability to read and understand Dutch manufacturing and quality documentation.