Senior Specialist Qualification and Validation

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.

For our site in **Krems**, we are currently looking for a:
**Senior Specialist** **Qualification and Validation (M/F/d)**

**temporary for 2 years**

The primary purpose of the position is to manage and drive Qualification and Validation related activities on site partnering with Site Validation Lead, Quality and Manufacturing whilst ensuring continued compliance with the principles of GMP as defined in current European and Austrian statute and guidance.

Qualification and Validation, Senior Specialist Term is responsible for implementing and managing C&Q-activities, qualification (DQ - IQ - OQ - PQ) as well as re-qualification; and validation as per the Project/Site Validation Master Plans. With expertise, provides support and coaching to the qualification and validation engineers in the team.

Based on the activities on site, this role should support Site Qualification and Validation Lead to setup/execute/track programs for the qualification, periodic review and re-qualification of equipment/systems, aseptic processing (Media Simulation) based on the site qualification and validation approach.

This role is for a 2-year period to support the Krems, Qualification and Validation department to ensure compliant facilities and equipment. The role includes strong partnership with the process experts of the IPTs as well as other stakeholders across the site.

**Main tasks**
- Leading assigned Qualification and Validation activities
- Responsible for being compliant with company safety guidelines and must be capable of recognizing unsafe situations and acting to be safe during job
- Issue, execution and maintenance qualification and validation plans to ensure continued compliance, including reports, in line with key site milestones
- Issue of Qualification Plans, Protocols and Reports; support different Equipment and Systems owner’s by providing technical knowledge
- Planning and execution of the qualification of equipment and systems as well as validation of processes together with the equipment
- and process owner (IPTs) for larger projects in corporation with supporting contractors and vendors
- Management of vendor for C&Q as well as validation activities
- Must be able to track qualification/re-qualification activities and must be able to communicate adequately (verbally/writing) at all levels within organisation
- Cooperation with peers and experts at site as well as within the company network
- Conducting periodic reviews and re-qualification programs are executed in a timely manner and deliverables (reports) are delivered as per the agreed schedule meeting compliance
- Perform Cycle development, Qualification and Re-Qualification of sterilization processes (thermal, chemical, other physical methods)
- Support / own the Risk Assessment Program for Qualification and Validation
- Participation and moderating in Risk Analysis of equipment, systems and processes
- Performing the equipment qualification basics including COTS and packaged equipment
- Responsible for training qualification and validation colleagues on respective topics. Potential to train staff on expertise in various areas
- Participating in Event/CAPA/Change control task management meetings. Providing input/information behalf of Validation department. Communicating the actions/proposals/information to the Validation department
- Supporting Change Management, Deviation Management process and CAPA management process on site and delivering assigned tasks in a timely manner
- Issue and maintenance of standards and standard operating procedures for qualification and validation based on internal and external guidelines and standards
- Planning and execution of Computerized Systems Validation (CSV) in corporation with IT and Process Automation - recipe qualification mínimal
- Supporting improvement projects and re-validation activities

**Qualification & Skills**
- Preferred 5 years of qualification experience in large scale production
- Degree in (bio)Chemistry/Process Technology, Biotechnology, Pharmaceutical Technology, Engineering; or comparable work experience
- Work experience in Manufacturing, Qualification/Validation and/or Aseptic Processing operations in a Pharmaceutical Company
- Strong Knowledge and Hands-On-Experience of (Bio) Process Technology; Microbiology, Aseptic Processing, and Equipment Design
- Experienced in the qualification and validation of cleanrooms, sterilization processes and aseptic process media simulation
- Relative experienced in CSV
- Hands on experience in typical installation qualification activities (PID walkdowns, Material certificate checks, isometric checks) and