Validation Engineer

Validation Engineer

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 Assistance 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.