QA Validation Engineer - Manufacturing Systems

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

Job summary

Abbott Nutrition Zwolle is seeking a Validation Engineer specializing in automation and digital systems to qualify equipment, processes, and systems across their lifecycle. You will work with Engineering, Operations, Quality Assurance and project teams on projects from upgrades to automation initiatives.

Strong background in GMP and validated environments is required; fluency in Dutch and English; experience in qualification/validation activities and multidisciplinary collaboration are

Qualifications

• Regulated manufacturing environment experience.
• GMP and quality system knowledge.
• Experience with qualification and validation activities.
• Fluent Dutch and English communication skills, both written and spoken.

Responsibilities

• Coordinate and execute qualification and validation activities for manufacturing equipment, facilities and automated systems.
• Develop and review validation protocols and reports, including IQ, OQ, PQ and Process Validation documentation.
• Support change control activities and assess validation impact throughout the lifecycle of validated systems.
• Participate in risk assessments and FMEA activities.
• Collaborate with Engineering, Automation, Operations and Quality teams to ensure compliant implementation of new and modified systems.
• Support automated manufacturing, digitalization and continuous improvement projects.
• Maintain validation compliance of existing systems through periodic review and lifecycle management activities.
• Monitor project progress and validation deliverables within multidisciplinary project teams.
• Support audits and inspections by providing validation subject matter expertise.

Education

Bachelor’s degree (HBO) or equivalent in Biotechnology, Pharmaceutical Sciences, Food Technology, Process Technology, Chemical Engineering, Automation Engineering, Mechatronics, Industrial Engineering, or related technical discipline

Tools

PLC

SCADA

MES

CSV

Job description

JOB DESCRIPTION:

Abbott Nutrition is continuously investing in manufacturing technology, automation and process improvements. To support these initiatives, we are looking for a Validation Engineer with an interest in automation and digital systems who can help ensure our equipment, processes and systems remain compliant throughout their lifecycle.

Within our QA Validation team, you will work closely with colleagues from Engineering, Operations, Quality Assurance, and project teams to support projects ranging from process improvements and equipment upgrades to automation and digitalization initiatives. While experience with automated systems is valuable, we are primarily looking for a strong validation professional who understands regulated manufacturing environments and enjoys working on a broad variety of projects. 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 Automation & Digital Systems, you will be responsible for qualification and validation activities throughout the lifecycle of equipment, processes, and systems associated with automated systems and process improvements. 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 qualification and validation activities for manufacturing equipment, facilities and automated systems.
• Developing and reviewing validation protocols and reports, including IQ, OQ, PQ and Process Validation documentation.
• Supporting change control activities and assessing validation impact throughout the lifecycle of validated systems.
• Participating in risk assessments and FMEA activities.
• Collaborating with Engineering, Automation, Operations and Quality teams to ensure compliant implementation of new and modified systems.
• Supporting automated manufacturing, digitalization and continuous improvement projects.
• Maintaining validation compliance of existing systems through periodic review and lifecycle management activities.
• Monitoring project progress and validation deliverables within multidisciplinary project teams.
• Supporting audits and inspections by providing validation subject matter expertise.

What you’ll bring

We are looking for a Validation Engineer with a strong quality mindset, solid manufacturing knowledge and an interest in automation and computerized systems.

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.
• Experience with manufacturing processes, equipment and automated production environments.
• 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 qualification and validation of automated manufacturing systems.
• Familiarity with PLC, SCADA, MES or other industrial automation systems.
• Experience with Computerized System Validation (CSV).
• Experience with System Life Cycle (SLC) methodologies.
• Knowledge of data integrity principles.
• Experience with risk assessment methodologies such as FMEA.

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.

Within QA Validation, you will have the opportunity to:

• Work on a wide variety of manufacturing, automation and improvement projects.
• Develop expertise in validation, automation and system lifecycle management.
• Collaborate with Engineering, Operations, Automation and Quality professionals.
• Contribute to the implementation of new technologies in a highly regulated environment.
• Grow your career within a global healthcare company committed to quality, innovation and continuous improvement.

If you enjoy combining validation expertise with technology, process improvement and cross-functional collaboration, we would love to hear from you.

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

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)