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Validation and Qualification Engineer
vor 4 Monaten
Job Description:
Our Manufacturing & Supply Division aims to be the most reliable supplier of biopharmaceuticals globally. The facilities, along with contractors, suppliers, and partners, form a robust global manufacturing network dedicated to delivering top-notch products to customers and patients consistently on schedule.
Our Manufacturing Operations teams are the backbone of our product creation. We operate in manufacturing plants with a mindset of "Safety First, Quality Always", always striving for enhancement. We collaborate with the local plant, ensuring top-notch quality of raw materials, intermediates, and finished products as part of our global manufacturing network.
For our location in Krems, we are currently seeking a:
Validation and Qualification Engineer (m/f/d)
for a two-year contract, starting at your earliest availability
Main Responsibilities:
- Leading assigned Commissioning, Qualification, and Validation (CQV) activities such as equipment, processes, cycles, sterilization, transport, etc.
- Developing and approving CQV Plans and Reports.
- Supporting equipment and systems owners with technical expertise.
- Establishing and/or participating in risk analysis and assessment to bolster CQV activities and change management.
- Backing Change Management, Deviation Management, and CAPA Management process on-site and ensuring timely task completion.
- Adhering to GMP, company, and local safety and CQV regulations.
- Potentially serving as a sub-system owner for qualification and validation topics.
- Supporting the site's CQV program through reviews, requalifications, Sanitization/Sterilization in Place (SIP), and Performance Qualifications (PQs) among others.
- Working collaboratively with a team and stakeholders to maintain the facility and equipment's qualified and validated status.
- Initiating and supporting continuous improvement activities within CQV and the site.
- Supporting the site in various Qualification and Validation aspects based on production needs during the two-year period.
Requirements:
- Minimum 3 years of experience in large-scale production qualification and validation.
- Degree in (Bio)Chemistry, Process Technology, Biotechnology, Pharmaceutical Technology, Engineering or relevant field.
- Fluency in written and spoken German and English along with proficiency in MS-Office applications.
- Experience in a Pharmaceutical Company, particularly in Aseptic Processing operations.
- Hands-On-Experience or knowledge in CQV, (Bio) Process Technology, Microbiology, and Aseptic Processing Equipment Design.
- Expertise in the qualification and validation of sterilization processes and aseptic media simulation.
- Knowledge in risk management, change management, deviations, and CAPAs management.
- Strong team player with strategic, analytical, and problem-solving skills.
We offer an attractive salary, outstanding social benefits, and a dynamic work environment with diverse tasks in an international setting. The minimum annual salary for this role is EUR 44.100,- and is subject to the candidate's qualifications and experience. We look forward to receiving your application.
