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Validation - Engineer (m/f/d)(Remote/Hybrid)

Bad Vilbel, Germany

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Company Overview


Join FrontWell Solutions, a leader in Laboratory Information Management Systems, Manufacturing IT, and Quality Assurance solutions for the life sciences sector. As a trusted consulting partner, we deliver advanced, compliant, and innovative digital solutions that drive operational excellence and regulatory success for our clients. Our expertise spans the full spectrum of pharmaceutical and biotech IT, with a focus on quality, compliance, and digital transformation.

Position Overview

FrontWell Solutions is seeking a highly skilled Senior Validation Engineer to join our growing team. In this role, you will lead and execute validation projects for computerized systems and manufacturing processes in regulated environments, ensuring compliance with GMP, GLP, GxP, and GCP standards. You will play a pivotal role in modernizing quality management systems, implementing Pharma 4.0 methodologies, and driving paperless validation initiatives using leading platforms such as Kneat, Valgenius, Polarion, DevOps, and Jira. Your expertise will help bridge the gap between regulatory requirements and digital innovation, supporting both consulting and in-house projects.

Customer Relationship
Personal Evolution
Autonomy
Administrative Work
Technical Expertise

Key Responsibilities

  1. Lead the planning, execution, and documentation of validation activities for computerized systems, equipment, and processes in compliance with GAMP5, CSV/CSA, and relevant regulatory standards. 
  2. Generate and review validation deliverables, including validation plans, user requirements, specifications, risk assessments, test protocols (IQ/OQ/PQ), and summary reports. ​
  3. Implement and support paperless validation solutions (e.g., Kneat, Valgenesis, Polarion, DevOps, Jira), driving efficiency and data integrity in validation processes. 
  4. Advise on and execute strategic validation QA initiatives, including QMS modernization and adoption of new methodologies aligned with Pharma 4.0.
  5. Provide quality control and QA IT support, ensuring robust compliance in pharmaceutical manufacturing and laboratory environments.
  6. Collaborate with cross-functional teams, including MES/LIMS/SAP specialists, to ensure seamless integration and validation of enterprise systems.
  7. Mentor and train team members and clients on validation best practices, regulatory requirements, and digital validation tools.
  8. Support audits and inspections, providing expert guidance on validation documentation and compliance strategies.

Qualifications


  • Bachelor’s or Master’s degree in Engineering, Life Sciences, Computer Science, or a related field. 
  • 3 to 5 years of experience in validation engineering within the pharmaceutical, biotech, or regulated life sciences industries. 
  • Deep knowledge of GMP, GLP, GxP, GCP, and GAMP5 standards, with a proven track record in computer system validation (CSV/CSA). 
  • Hands-on experience with paperless validation platforms (Kneat, Valgenius, Polarion, DevOps, Jira, Kneat GxP, Automated Testing tools). 
  • Familiarity with MES, LIMS, and SAP systems as secondary skills. 
  • Strong technical writing skills and experience generating validation documentation and deliverables. 
  • Demonstrated ability to lead validation projects, modernize QMS, and implement new validation methodologies. 
  • Excellent communication skills, with the ability to work effectively in both consulting and in-house environments. 
  • Professional fluency in English and German (B2 or higher) is preferred. 
  • Solid understanding of pharmaceutical manufacturing processes, quality control, and regulatory requirements.

Why Join FrontWell Solutions?


At FrontWell Solutions, we offer more than just a competitive salary. We are committed to fostering a transparent, supportive, and innovative work environment where your expertise is valued and your career can thrive. With us, you will benefit from: 

  • Fair Work Conditions: Transparent and equitable policies for all employees. 
  • Remote Work Infrastructure: Advanced tools and support for seamless remote collaboration. 
  • Innovative Culture: A start-up spirit that encourages creativity, continuous learning, and the adoption of cutting-edge technologies. 
  • Empowerment and Feedback: A culture built on trust, empowerment, and constructive feedback to support your personal and professional growth. 
  • Career Growth: Tailored career development plans, early responsibility, and opportunities to lead impactful projects. 
  • Work-Life Harmony: Flexible arrangements to support your work-life balance and personal preferences. 

Ready to shape the future of validation in life sciences? For more information or to apply, contact us directly. 

Your FWS Team! 


Apply Now!