Manufacturing Operations Specialist

Vor 7 Tagen

Wien, Wien, Österreich Talentor Austria GmbH Vollzeit

Join our client, a pioneer in the life science sector, as they continue to drive innovation and growth in their field. Located in Vienna, this exciting opportunity is perfect for an expert in formulation and aseptic filling who wants to take on new challenges and responsibilities.

About the Company

Our client is characterized by a fast-paced environment, innovative approach, and strong team spirit. As a leader in their field, they offer a diverse range of tasks and opportunities for growth and development.

This role involves assisting senior team members in daily technical activities, supporting project management initiatives, and contributing to the development of technical plans aligned with product strategies. If you are a hands-on, results-oriented professional with extensive project management skills, we encourage you to apply.

The ideal candidate will have experience in a cGMP manufacturing environment, preferably in technical operations or large-scale commercial pharmaceutical manufacturing. Knowledge of pharmaceutical manufacturing processes, particularly sterile injectable products, is also essential.

A few years of experience working with external suppliers or within a cross-functional organization would be beneficial. The successful candidate will be fluent in English, with German being a plus. Willingness to travel from time to time is required.

Job Description

This newly created position offers a unique opportunity to actively shape the company's success. You will assist as a technical contact for assigned external partners and internal departments across downstream and upstream manufacturing sites.

  • Support senior team members in daily technical activities for commercial manufacturing, such as reviewing process change requests and deviation reports.
  • Assist in managing projects related to vaccine production, including process improvements, capacity expansion, and product introductions.
  • Conduct technical evaluations, such as deviations and CAPAs.
  • Contribute to the development and implementation of technical plans aligned with product strategies.
  • Support risk management activities and product lifecycle processes, including tech transfers and product launches.
  • Participate in troubleshooting and problem-solving initiatives under the guidance of senior colleagues.
  • Provide support for Change Control processes and prepare technical impact assessments.
Requirements

To succeed in this role, you should have:

  • A few years of experience in a cGMP manufacturing environment, ideally in technical operations or large-scale commercial pharmaceutical manufacturing.
  • Knowledge of pharmaceutical manufacturing processes, particularly sterile injectable products, with hands-on experience in a plant setting.
  • Experience working with external suppliers or within a cross-functional, matrix organization.
  • Eager to learn and grow under the guidance of experienced team members.
  • Hands-on, results-oriented, and dynamic team player with extensive project management skills.
  • Understanding of cGMP, post-approval changes, ICH guidelines, and regulatory validation.
  • Fluent in English; German is a plus.
  • Willingness to travel from time to time.
Salary and Benefits

We offer a competitive gross annual salary of €70,000 (excluding bonus), which may be adjusted based on your qualifications and work experience. Our company provides a diverse range of tasks, a promising pipeline, and the opportunity to actively shape its success. Successful candidates can expect a dynamic and supportive work environment, with opportunities for growth and development.

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