(Senior) Consultant Qualification & Validation

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Join to apply for the (Senior) Consultant Qualification & Validation role at Arcondis Group

Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries. Headquartered in Basel, Switzerland, the company has a global footprint with offices in North America, APAC and across Europe. We have been managing challenges and solving problems for our clients in compliance, business processes, information technology, and digital transformation since 2001. Our focus lies in creating value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.

We are a medium-sized international consulting firm dedicated to Life Sciences, with a unique and inspiring culture. Our distinctive culture is the driving force behind our success; it is deeply rooted in our purpose and behaviours. We are owned by a charitable Foundation; our key differentiator is that we contribute to social causes every year. This ethos is not just a part of our identity; it is our way of life. Our motto, "We make healthcare better," reflects the unwavering commitment we have to improving the lives of people through the work we do.

Our culture fosters collaboration, innovation, and a sense of community that sets us apart from the rest. We are living our values every day. Our leadership is expected to lead by example, demonstrating a dedication to our mission and values.

We embrace diversity and inclusiveness, and we believe in giving back to the community. Together, we are not just consultants; we are agents of change, and our culture is the driving force behind our shared purpose.

Responsibilities

• Independently lead validation and qualification activities for equipment, utilities, facilities, computerised systems and processes
• Ensure high-quality, compliant deliverables according to GxP standards and regulatory requirements (e.g. FDA, EMA, WHO, ISPE GAMP 5)
• Prepare, review and approve validation documentation, including Validation Plans, Risk Assessments, URS, IQ/OQ/PQ protocols and Validation Reports
• Troubleshoot validation-related issues, identify root causes and propose pragmatic, compliant solutions
• Prepare, execute and document processes validation for Manufacturing, Labelling and Packaging
• Prepare, execute and document Method validation for Analytical Methods in QC and IPC
• Prepare, execute and document cleaning validation for Production line and equipment like cleaning, mobile & multipurpose
• Manage project timelines, resources and deliverables to ensure successful project execution
• Act as the main client contact for validation-related topics, leading client meetings, workshops and project communications
• Build and maintain strong client relationships, ensuring client satisfaction and identifying additional business opportunities
• Mentor and support junior team members in validation best practices, documentation standards and regulatory expectations
• Contribute to the continuous improvement of validation and qualification methodologies and internal processes
• Participate in internal initiatives, such as knowledge management, tool evaluations and thought leadership (e.g. whitepapers, webinars)
• Lead quality assurance activities within validation projects, ensuring adherence to internal and client-specific quality standards
• Support change management activities related to validation projects, helping clients manage regulatory changes and new technologies
• Identify areas where digital tools and automation could enhance validation efficiency and propose appropriate solutions

Qualifications and Experience

• Bachelor’s, Master’s degree or PhD in Life Sciences, Engineering, Computer Science or a related field
• Additional certifications (advantageous): e.g. GAMP5 Practitioner, Computer System Validation (CSV) certifications, Six Sigma Green Belt
• 3–5 years of hands-on experience in Validation and Qualification within the Life Science industry (e.g. pharma, biotech, medtech)
• Proven experience leading validation and qualification activities (equipment, utilities, facilities, computer systems, processes)
• Demonstrated track record in managing client-facing projects, including client communication and relationship management
• Experience in risk-based validation approaches and knowledge of current regulatory expectations (e.g. FDA 21 CFR Part 11, EU Annex 11, ISPE GAMP 5)
• Practical experience in authoring, reviewing and approving validation documentation (Validation Plans, URS, IQ/OQ/PQ protocols, Validation Reports)
• Deep understanding of GxP, data integrity and regulatory requirements across global markets (FDA, EMA, WHO)
• Advanced knowledge of validation project management methodologies (traditional and agile approaches)
• Proficiency with validation lifecycle management tools (e.g. ValGenesis, Kneat Gx)
• Strong analytical skills, including root cause analysis and risk assessment in validation contexts
• Ability to implement digital validation solutions and drive process optimisation initiatives
• Strong communication and presentation skills, including the ability to lead client meetings, workshops and audits
• Excellent problem-solving skills, with the ability to propose innovative, compliant solutions
• High adaptability to manage change and ambiguity in dynamic project environments
• Strong time management skills with the ability to handle multiple validation projects in parallel
• Ability to mentor junior colleagues and support their development
• Strong self-reflection and continuous improvement mindset
• Cultural awareness and the ability to work effectively in diverse, international teams
• Very good command of English and German

Why Arcondis

• An opportunity to shape the future of healthcare by spearheading transformative deals
• A collaborative and innovative work environment, where your ideas are valued, and your contributions make a significant impact
• Flexible working environment, enabling work-life balance
• Attractive compensation package, inclusive of performance-based incentives that reward exceptional achievements
• Professional growth and development opportunities

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Consulting

• Industries

  Business Consulting and Services

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Global MSAT Drug Product Qualification and Validation Lead 80-100% (m/f/d)

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