(Senior) Consultant Qualification & Validation

Arcondis Group; Deutschland; Vor Ort; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

Arcondis Group seeks a (Senior) Consultant Qualification & Validation to lead qualification and validation activities for equipment, utilities, facilities and processes in regulated life sciences environments.

The role combines technical delivery, project coordination and client engagement to deliver compliant, high-quality outcomes with a focus on risk-based approaches and modern digital tools.

Qualifikationen

• Bachelor’s, Master’s or PhD in Life Sciences, Engineering, Computer Science or related field is required.
• Experience leading qualification and validation for equipment, utilities, facilities and processes.
• Strong knowledge of GxP, data integrity and global regulatory expectations.

Aufgaben

• Lead qualification and validation activities for production equipment, utilities and facilities, including cleanrooms and warehouses.
• Prepare, review and approve qualification & validation documentation (plans, URS, IQ/OQ/PQ, reports).
• Execute and document testing per GxP standards and client requirements.
• Plan, execute and document process validation for manufacturing, labeling and packaging; analytical method validation; cleaning validation.

Kenntnisse

Project management

Analytical thinking

Risk assessment

Problem solving

Communication

Mentoring

German and English

Ausbildung

Bachelor’s/Master’s/PhD in Life Sciences or related field

Tools

ValGenesis

Kneat Gx

Jobbeschreibung

Overview

The (Senior) Consultant Qualification & Validation leads qualification and validation activities for equipment, utilities, facilities and processes within regulated life sciences environments. The role combines technical delivery, project coordination and client engagement to produce compliant, high-quality outcomes.

Overview

The (Senior) Consultant Qualification & Validation leads qualification and validation activities for equipment, utilities, facilities and processes within regulated life sciences environments. The role combines technical delivery, project coordination and client engagement to produce compliant, high-quality outcomes.

Key Responsibilities

• Lead qualification and validation activities for production and quality-control equipment, utilities and facilities, including cleanrooms and warehouses.
• Prepare, review and approve qualification and validation documentation, including plans, user requirements specifications, risk assessments, IQ/OQ/PQ protocols and reports.
• Execute and document testing in accordance with Good Documentation Practice, client requirements and applicable GxP standards.
• Plan, execute and document process validation for manufacturing, labelling and packaging, analytical method validation for QC and IPC, and cleaning validation for production lines and equipment.
• Troubleshoot qualification and validation issues, identify root causes and recommend practical, compliant solutions.
• Manage project timelines, resources, deliverables and communications.
• Act as the main client contact for qualification and validation topics and lead workshops with clients and vendors.
• Support clients with regulatory changes, new technologies and related change-management activities.
• Build client relationships, maintain client satisfaction and identify additional business opportunities.
• Mentor junior colleagues and contribute to improved methodologies, digital tools, automation, knowledge management and thought leadership.

Qualifications

• Bachelor’s, Master’s degree or PhD in Life Sciences, Engineering, Computer Science or a related field.

Skills

• Strong project and time-management skills, with the ability to manage multiple qualification and validation projects in parallel.
• Strong analytical, root-cause analysis and risk-assessment skills.
• Excellent problem-solving skills and the ability to recommend innovative, compliant solutions.
• Strong communication and presentation skills, including leading client meetings, workshops and audit discussions.
• Ability to mentor junior colleagues and support their development.
• Adaptability, self-reflection and a continuous-improvement mindset.
• Cultural awareness and the ability to work effectively in diverse international teams.
• Flexibility and mobility to work on site at client locations.
• Very good written and spoken German and English; German is mandatory.

Experience and Knowledge

• 3 - 5 years of hands-on qualification and validation experience within pharmaceutical, biotechnology, medical technology or another life sciences environment.
• Experience leading qualification and validation activities for equipment, utilities, facilities and processes.
• Experience managing client-facing projects and client relationships.
• Experience with risk-based qualification and validation approaches and current expectations including FDA 21 CFR Part 11, EU Annex 11 and ISPE GAMP 5.
• Practical experience authoring, reviewing and approving qualification and validation plans, user requirements, IQ/OQ/PQ protocols and reports.Strong knowledge of GxP, data integrity and global regulatory expectations, including FDA, EMA and WHO requirements.
• Experience using qualification and validation lifecycle tools such as ValGenesis or Kneat Gx.
• Experience implementing digital qualification and validation solutions or process optimisation initiatives.

Advantageous

• GAMP 5 Practitioner, Computer System Validation or similar relevant certification.