Equipment Qualification & Validation Specialist

QbD Group

Barcelona

On-site

EUR 52,000 - 76,000

Full time

27 hours ago
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Job summary

QbD Group in Barcelona is seeking a Qualification & Validation Specialist who thrives on quality, precision, and compliance to ensure life sciences systems and equipment meet the highest standards from installation through performance.

You will lead validation activities (IQ/OQ/PQ), support CSV, drive CAPA investigations, and help maintain audit-ready documentation, data integrity, and change control across projects in pharma, biotech, and medical devices.

Qualifications

  • QA, computer system validation (CSV), and automated processes experience.
  • Validation of products, equipment, processes, risk management, and data integrity.
  • Proficiency navigating GMP, FDA, EMA and local quality guidelines; Annex 1 awareness.
  • Proactive, results-oriented, and detail-focused; capable of independent and collaborative work.

Responsibilities

  • Bring a quality-first mindset to validation and qualification activities, ensuring alignment with internal policies and regulatory standards.
  • Collaborate on IQ/OQ/PQ validations and test method validations, turning technical precision into shared success.
  • Drive nonconformance and CAPA investigations with clear action plans and timely resolution.
  • Proactively share insights to enhance quality policies and validation procedures, helping the team grow stronger.
  • Represent QA as a trusted partner in cross-functional projects with expertise and enthusiasm.
  • Provide hands-on training, coaching, and support in validation, quality systems, and CSV.
  • Ensure change control processes are followed and audits remain ready throughout lifecycle.
  • Monitor performance with regular system reviews to ensure ongoing compliance and improvements.
  • Implement data integrity and traceability controls to tell the full quality story.
  • Step up as SME during internal and external audits with confidence and clarity.

Skills

QA experience
CSV expertise
GMP knowledge
Regulatory knowledge
CAPA investigations

Education

BSc in Life Sciences
BSc in Exact Sciences
BSc in Computer Science
BSc in Engineering

Job description

Are you the kind of person who won’t rest until every system, process, and piece of equipment runs exactly as it should — and can prove it?

We’re looking for a Qualification & Validation Specialist who’s passionate about quality, precision, and ensuring that life-saving products are backed by rock-solid compliance.

In this role, you’ll play a vital part in guaranteeing that critical equipment and systems meet the highest standards — from installation to performance. If you thrive on structure, enjoy solving technical challenges, and want to make a real impact in the pharmaceutical or life sciences world, then this could be the perfect next step in your career.

What’s in it for you?

Make a real impact: Contribute to shaping the future of the Life Sciences industry by supporting innovative projects and clients across pharma, biotech and medical devices

Grow within a community of experts: Benefit from knowledge-sharing, mentoring, and exposure to diverse, challenging assignments that broaden your expertise.

Build a meaningful career: As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.

A fair, competitive package: We offer tailored, transparent compensation aligned with your expertise, preferences, and local market regulations — because your contribution deserves to be valued.

What you’ll be doing
  • Bring a positive, quality-first mindset to validation and qualification activities, ensuring full alignment with internal policies and regulatory standards
  • Collaborate closely on process validations (IQ/OQ/PQ) and test method validations, turning technical precision into shared success
  • Drive nonconformance and CAPA investigations with focus and ownership, ensuring clear action plans and timely resolution
  • Proactively share your insights to enhance our quality policies and validation procedures, helping the team grow stronger together
  • Represent QA as a trusted partner in cross-functional projects, contributing with expertise and enthusiasm
  • Empower others by delivering hands-on training, coaching, and support in validation, quality systems, and CSV
  • Ensure change control processes are followed with care and discipline — keeping systems validated and audit-ready throughout their lifecycle
  • Keep a close eye on performance through regular system reviews, ensuring compliance is maintained and improvements are made
  • Put controls in place to protect data integrity and traceability, making sure our quality records tell the full story
  • Step up as a subject matter expert during internal and external audits — including the high-stakes ones — with confidence and clarity
What you bring
  • You bring a solid academic foundation with a BSc degree in Life Sciences, Exact Sciences, Computer Science, or Engineering
  • You have hands-on experience in QA, computer system validation (CSV), or automated processes, and a practical understanding of validating products, equipment, processes, risk management, and data integrity
  • You’re confident navigating regulatory landscapes, with working knowledge of GMP, FDA, EMA, and local quality guidelines. You have a good understanding of Annex 1 guidelines for validation purpose.
  • You’re proactive, results-oriented, and flexible — someone who pays attention to the details, takes ownership, and thrives both independently and in close collaboration with others
Who you are
  • You’re resilient and tackle challenges with a positive mindset
  • You’re curious and always up for learning something new
  • You have a no non-sense approach honest, clear, respectful
  • You’re innovative and bring ideas, not just opinions
  • And above all, you’re serious about your work, but not too serious about yourself

We support life sciences companies from idea to patient — offering tailored solutions in development, clinical, regulatory, compliance, production, and distribution. With 500+ experts across 8 countries, we help drive innovation in ATMP, biotech, medical devices, diagnostics, digital health, and pharma.

We believe in JPEG:

Joy. Partnership. Going the Extra Mile. Getting Things Done.

You won’t just be taking a job — you’ll be joining a community where people grow, laugh, build, and contribute to something bigger.

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