As Validation Operations Engineer you will oversee validation and qualification activities in compliance with cGMP and internal standards, direct external vendors, and act as backup for the Project Engineer and C&Q Supervisor.

Your main tasks

• Acting as Qualification/Validation Lead for defined areas
• Developing and justifying validation approaches based on risk and scientific rationale
• Ensuring compliance of equipment, systems, and processes with cGMP and internal standards throughout their lifecycle
• Authoring and reviewing qualification/validation documents (plans, protocols, reports, etc.)
• Executing or supervising validation/qualification activities across all site systems (QC, facilities, lab equipment, utilities, computerized systems
• Managing periodic requalification/revalidation activities
• Supporting the development and upkeep of site-specific procedures
• Aligning site validation strategies with global standards
• Leading risk assessments and managing mitigation plans
• Reviewing change controls and maintenance interventions for impact on validated systems
• Coordinating validation efforts with vendors and internal teams
• Supervising internal and external project resources
• Supporting onboarding and training for new team members
• Acting as expert during audits and inspection
• Driving continuous improvement initiatives and fostering collaboration across departments

Your profile

• Degree in Engineering, Technical discipline, or equivalent experience
• Minimum 5 years of experience in pharmaceutical validation
• Strong knowledge of international regulatory standards and cGxP requirement
• Solid understanding of ALCOA principles and data integrity
• Familiarity with pharmaceutical facilities (HVAC, utilities), manufacturing and lab equipment, and computerized system validation (CSV)
• Proactive and collaborative communication skills
• Problem-solving mindset with a strong sense of responsibility
• Effective team player with strong customer focus
• Good command of English; French skills preferred

Domagoj Odrljin is looking forward to receiving your application documents via our job portal (CV, diploma, reference letters; no motivational letter necessary).Full discretion is guaranteed and we will gladly answer any additional questions.