Quality Technician Validations and Qualifications

Quality Technician Validations and Qualifications

What we do

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated.  We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here.

Role reports to:

Quality Assurance Lead & QP

Location:

Europe/Middle East/Africa, Spain, Community of Madrid, Madrid

Work Location:

Fully Onsite

What you will do

The Quality Technician Validations and Qualifications is responsible for supporting validation and qualification activities, analyzing data trends, and assisting in the development and review of quality and validation documentation to ensure compliance with company standards and continuous improvement. You will also provide technical support and backup for product release and other QA functions:

Key Responsibilities

• Validation and Qualification Oversight. Responsible for the oversight of production and laboratory equipment qualifications, computerized system validation (CSV), process and cleaning validation, and facility and utility qualifications. This includes participation in validation and qualification strategy development, ensuring compliance with applicable regulatory requirements, reviewing and approving qualification and validation documentation, periodic reviews, and annual monitoring reports. Responsibilities also include the review of SCADA system configurations and participation in troubleshooting, continuous improvement, and equipment-related initiatives.

• Collaborate with cross-functional teams to develop, refine, and ensure validation and qualification strategies meet customer, organizational, and operational efficiency expectations.

• Oversight and support for calibration and maintenance activities. Approval of calibration and maintenance plans and spare parts/replacements. Review of compliance with monthly calibration and maintenance schedules.

• Identify, escalate, and resolve validation and quality issues promptly to maintain operational efficiency and promote a culture of continuous improvement.

• Maintenance of the site's annual Validation Master Plan (VMP). Oversight of annual validation and qualification plans across different functional areas.

• Perform comprehensive reviews of manufacturing and batch documentation to ensure compliance with quality standards and regulatory requirements. Manage any deviations or non-compliance issues in accordance with established local procedures.

• Documentation Updates. Review, update, and/or approve local Standard Operating Procedures (SOPs) and SOPs from other functional areas related to GMP, ensuring compliance with current regulatory requirements and corporate policies.

• Shutdowns. Ensure that, following an extended manufacturing plant shutdown, all necessary actions have been completed to guarantee regulatory compliance and product quality requirements are met before production operations are resumed.

• Engage in continuous learning and application of emerging quality assurance technologies and actively participate in business initiatives aimed at enhancing service excellence and operational effectiveness.

• Create, maintain, and support dynamic documentation, reporting tools, and statistical summaries to streamline compliance, audit readiness, and quality assurance initiatives.

• Provide technical support, training, and clear communication on validation requirements to optimize data management, reporting, and stakeholder engagement.

• Monitor, analyze, and interpret data trends from validation activities, service, and complaint databases to identify areas for process improvement, risk mitigation, and continuous improvement opportunities.

What we are looking for

Required Qualifications

• Bachelor’s degree in pharmacy

• At least 6 years of experience in quality assurance and validation/qualification departments

• Thorough knowledge of good manufacturing practices and quality system standards, including ISO standards and ISPE and GAMP5 guidelines.

• Professional proficiency in Spanish and English (written and spoken) is required to effectively operate in a multilingual and international environment.

• Effective communication skills to collaborate with cross-functional teams.

Desired Qualifications

• Proficiency in Microsoft Office applications.

• Proficiency in data analysis and the ability to interpret complex datasets to drive quality decisions.

• Strong problem-solving skills with a creative mindset to develop novel approaches to validation challenges.

• Capability to identify trends, troubleshoot issues, and contribute to continuous improvement initiatives.

• Excellent communication skills to effectively collaborate with multidisciplinary teams and document technical findings.

• Previous experience with computerized systems, including Symphony, Veeva, SAP, LIMS, and DeltaV, is highly desirable.

• Experience with liquid, solid, and semi-solid pharmaceutical dosage forms will be considered an advantage.

• Previous experience in project management is considered an asset.

What’s in it for you

• Competitive Benefit Package*        
• Medical Insurance
• Pension Plan   
• Learning & Development Opportunities        
• Kenvuer Impact Networks        
• Canteen onsite

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.