Validation Operations Engineer - Pharma Industry 100% E/F (Ref. 2549) - 3 months contract, Grand-Region Neuchâtel

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.