Validation Engineer
Overview
At QIAGEN, we are driven by a simple but powerful vision: making improvements in life possible.
We’re dedicated to revolutionizing science and healthcare for the better. From our entrepreneurial roots to our current global presence, we've grown into a force for positive change. With thousands of employees across six continents, collaboration is our greatest strength. We’re always striving to identify talented individuals to join our exceptional teams.
We have played a pivotal role in shaping modern science and healthcare, and we're just getting started. If you're someone who thrives on new challenges, values diversity and wants to make a tangible difference in people's lives, then QIAGEN is the place for you.
At QIAGEN, every day is an opportunity to make a real-life impact.
Join us, grow with us, and together, let's shape the future of biological discovery.
About the opportunity
Join QIAGEN as a Validation Engineer and contribute to ensuring the quality, safety, and compliance of our manufacturing processes and equipment. In this role, you will lead validation activities for injection molding tools and processes across their lifecycle, working closely with cross-functional teams to maintain compliance with global regulatory standards such as ISO 13485 and GMP.
This is an onsite based role at QIAGEN Barcelona.
Please send your CV in English!
Your tasks include
Planning, executing, and documenting validation activities (DQ, IQ, OQ, PQ) for injection molding tools, equipment, and manufacturing processes
Developing and maintaining validation plans, protocols, and reports in line with GMP and internal quality standards
Ensuring compliance with regulatory requirements (e.g., ISO 13485, GMP) throughout the product lifecycle
Managing revalidation activities and assessing the impact of technical changes on validated systems
Investigating deviations, non-conformities, and out-of-specification results, including conducting root cause analysis and implementing CAPAs
Collaborating with Quality Assurance, R&D, and external partners to align validation strategies
Reviewing and approving technical documentation, including specifications, risk analyses (FMEA), and change requests
Supporting audits and inspections by providing validation documentation and technical expertise
Your profile
Degree in Engineering (e.g., Plastics, Mechanical, or Process Engineering) or a comparable technical qualification
Proven experience in validation within a regulated environment such as medical devices, pharmaceuticals, or life sciences
Strong knowledge of validation principles, risk management, and regulatory standards (e.g., ISO 13485, GMP)
Experience with manufacturing processes, ideally injection molding or plastics technologies
Familiarity with statistical methods and validation tools is advantageous
Fluent English required, German is a plus
What we offer
Meal voucher
Health Insurance (conditional to your role)
Bonus/Commission
Referral Program
Employee Assitance Program
Our people are the heartbeat of everything we do. Passion drives us as we push boundaries to innovate and evolve. We inspire with our leadership and make an impact with our actions. We cultivate a collaborative, supportive environment where each individual and team can flourish. We champion accountability and encourage entrepreneurial thinking.
QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.