QA Validation Engineer - Equipment, Process & Lifecycle
Abbott Zwolle, Overijssel, Netherlands
Hospitals and Health Care · 10,001+ employees
About the role
The Validation Engineer will coordinate and execute qualification and validation activities for equipment, processes, and systems throughout their lifecycle. They will also serve as a quality representative in multidisciplinary projects to ensure compliance with internal standards and regulatory requirements.
What they look for
Requirements
Candidates must hold a bachelor's degree in a relevant technical discipline such as Biotechnology, Pharmaceutical Sciences, or Engineering. Experience in a regulated manufacturing environment and knowledge of GMP and quality systems are required.
Benefits
Full 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.
If you are motivated to develop your validation expertise and contribute to a world-class manufacturing environment, we would love to hear from you.
The base pay for this position is
N/AIn 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
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Keyboard use (greater or equal to 50% of the workday)
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