Senior Product and Validation Expert 

Location: Onsite in Vienna, Austria 

Albion Rye Associates are proud to be partnered with a global leader within the pharmaceutical industry who are at the forefront of R&D and Innovation within medications and vaccines.

Responsibilities

• End to end responsibility for specific product(s)/product group(s)
• Project management as the product expert
• Permanent optimization of production processes (granulation, tableting, coating of tablets, mixing)
• Evaluation and implementation of process changes, alternative suppliers for APIs (Active Pharmaceutical Ingredients), and selection of production facilities with regard to new technologies
• Implementation of product transfers, design of experiments (DoEs) and execution of test batches, definition of process parameters
• Owner of change requests, CAPAs, and events, preparation of registration documents
• Contact person for authority inspections (FDA, AGES…) regarding process validations and production processes.

Requirements

• 4+ years’ experience in process validation within the Pharmaceutical Industry
• Experience with Product Transfer, Process Transfer, process changes and CAPA
• Experience in project management and/or as a process optimization expert is strongly preferred.
• Completed technical or scientific studies required.
• Several years of experience in the pharmaceutical industry as well as experience in process validation
• Can speak German and English
• Experience with regulatory inspections
• Knowledge of the production processes of solid dosage forms an advantage.
• Problem-solving skills, personal responsibility, and decision-making ability.