Associate Director Aseptic Process Support

vor 2 Wochen

Krems an der Donau, Österreich MSD Vollzeit

**Job Description**:
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.

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

For our site in Krems, we are currently looking for a:
**Associate Director, Aseptic Process Support**

We are looking for an Aseptic Process Support Program Lead for the Krems manufacturing site.

The role is supporting the strategic development of the Aseptic Process Solutions program and providing hands on implementation support for the indicated manufacturing site.

The Associate Director, Aseptic Process Support is responsible for the deployment of resources in the site and across the network to support successful implementation and sustainability of the program.

**Main tasks**
- Providing tactical leadership in the development, implementation, and maintenance of aseptic practices within the Krems site in the network
- Establish and direct deployment/implementation of proactive measures across Sterile facility to enhance and sustain aseptic programs
- Partner with the companies Sterile Councils to ensure compliance to internal standards and (local) regulatory guidelines
- Develop and lead with other APS colleagues the Sterile Community of Practice within the network
- Provide investigation support in case of Media Simulation failure, Sterility failure and other Aseptic Process-related deviations
- Provide hands on support in implementation of Aseptic Processing Policies and Standards
- Raising the level of Aseptic Robustness in the Krems site in areas of identified weakness (Technology, Operator Training, Engineering Design, etc.)
- Interact closely with the Krems Site Management team (in particular operations, quality operations and support functions) to support establishment and sustaining of procedures and practices allowing for a robust manufacturing process meeting relevant Aseptic Process standards in Krems site.

**Skills**
- Bachelor of Science degree in microbiology, engineering or a related discipline
- Minimum 5-10 years’ experience in the Manufacturing Industry, working in sterile environments with a strong background in microbiology and sterile process equipment design and/or biological production process development
- Required is extensive hands-on experience in the development of aseptic programs including Media simulations, Smoke studies, Clean Room Qualification, Steam-in-Place validation and Environmental Monitoring.
- knowledge and expertise in utilities systems (like e.g. clean steam and WFI) is required.
- strong analytical, problem solving, and technical writing skills required
- capability to guide contamination and AP-deviation investigations and lead the team to a proper problem-solving approach
- interpersonal skills including leadership, coaching and development, performance management, motivation, communications and negotiations.
- ability and experience to think at a global and strategic level and develop risk assessments, action plans, and position papers along with supporting rationale.
- fluent in English writing and verbal communication.
- Ability to communicate with Senior Site Management about strategy for the site to establish a robust (aseptic) manufacturing environment.
- hands on experience in the development and enhancement of sterile standards within the manufacturing environment.
- knowledge of current and upcoming Annex 1 requirements and translation into standards for Aseptic Processes in Operations and Quality Operations

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R253316

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