QA Validation Engineer - Equipment, Process & Lifecycle

Abbott; Zwolle; On-site; EUR 65,000 - 90,000; Full time

Job summary

Abbott Nutrition Zwolle is a leading nutrition manufacturing site delivering products globally. As a Validation Engineer, you will lead qualification and validation activities for equipment, processes and systems, ensuring compliance with GMP and internal standards.

You will collaborate with Engineering, Operations and QA on risk assessments, change controls and continuous improvement, participate in audits, and help lifecycle management of validated assets.

Qualifications

• Bachelor’s degree HBO or equivalent in a technical discipline.
• Experience in regulated manufacturing and qualification/validation activities.
• Knowledge of GMP and quality systems.
• Fluent Dutch and English communication skills.

Responsibilities

• Coordinate and execute equipment qualification and validation activities.
• Develop and review validation protocols and reports (IQ, OQ, PQ, Process Validation).
• Support change control activities for validated systems and processes.
• Participate in risk assessments and FMEA activities.
• Collaborate with Engineering, Operations and QA to implement changes in a controlled manner.
• Support lifecycle management of validated systems.
• Monitor validation status and ensure timely completion of deliverables.
• Contribute to continuous improvement within validation and quality systems.
• Assist audits and inspections with validation expertise.

Skills

Analytical thinking

Problem solving

Dutch language

English language

Education

Bachelor’s degree HBO or equivalent

Job description

JOB DESCRIPTION:

At Abbott, we believe good health is the foundation for everything.As a Validation Engineer, you will contribute to ensuring that our manufacturing processes, equipment, and systems consistently meet the highest quality and compliance standards.

Within our QA Validation team, you will work closely with colleagues from Engineering, Operations, Quality Assurance, and project teams to support both day-to-day operations and strategic improvement initiatives. This is an excellent opportunity for a validation professional who enjoys working in a dynamic manufacturing environment and wants to contribute to products that make a meaningful difference in people’s lives.

What you’ll do

As a Validation Engineer, you will be responsible for qualification and validation activities throughout the lifecycle of equipment, processes, and systems. You will serve as a quality representative in multidisciplinary projects and help ensure compliance with internal standards and regulatory requirements.

Your responsibilities include:

• Coordinating and executing equipment qualification and validation activities.
• Developing and reviewing validation protocols and reports, including IQ, OQ, PQ and Process Validation documentation.
• Supporting change control activities for validated systems and processes.
• Participating in risk assessments and FMEA activities.
• Collaborating with Engineering, Operations and QA to implement changes in a controlled and compliant manner.
• Supporting the lifecycle management of validated systems.
• Monitoring validation status and ensuring timely completion of validation deliverables.
• Contributing to continuous improvement initiatives within the validation and quality systems.
• Supporting audits and inspections by providing validation subject matter expertise.

What you’ll bring

We are looking for a team player with a strong quality mindset and the ability to work independently within a regulated manufacturing environment.

Required:

• Bachelor’s degree (HBO) or equivalent working and thinking level in:
  • Biotechnology
  • Pharmaceutical Sciences
  • Food Technology
  • Process Technology
  • Chemical Engineering
  • Automation Engineering
  • Mechatronics
  • Industrial Engineering
  • or a related technical discipline.
• Experience working in a regulated manufacturing environment and participation in qualification and validation activities.
• Knowledge of GMP and quality systems.
• Strong analytical and problem-solving skills.
• Ability to work effectively in multidisciplinary project teams.
• Fluent Dutch and English communication skills, both written and spoken.

Preferred:

• Experience with IQ/OQ/PQ execution.
• Knowledge of risk analysis methodologies such as FMEA.
• Experience with change control processes.
• Familiarity with automated manufacturing systems.
• Experience within the food, pharmaceutical, medical device, biotechnology or process industry.

What you’ll find at Abbott

Abbott Nutrition Zwolle is one of Abbott’s largest nutrition manufacturing sites worldwide. We produce high-quality nutritional products that are distributed across the globe.

Joining Abbott means becoming part of a company that values:

• Quality and compliance.
• Continuous improvement.
• Professional development.
• Cross-functional collaboration.
• A culture where people can grow and make a real impact.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

ANSC Nutrition Supply Chain

LOCATION:

Netherlands > Zwolle : Building 1

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Keyboard use (greater or equal to 50% of the workday)