For our client, an innovative pharmaceutical company with its international headquarter based in the French part of Switzerland, we are searching for a:
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.
AurigaVision AG
Herr Domagoj Odrljin
Baarerstrasse 139
6300 Zug
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