Jobs for life scientists

Senior Computer System Validation Manager (f/m/d)

Octapharma specializes in the development of highly pure pharmaceuticals made of human blood plasma. As part of a family-owned enterprise, Octapharma in Vienna is not only the largest production site, but also a successful research location of the Octapharma Group. Since our company continues to grow, we are now hiring for our team:

Senior Computer System Validation Manager (f/m/d)

Your new challenges which will inspire you:

  • Plan and manage assigned computer system validation projects ensuring the validation of corporate computerized systems used across GxP-operations are conducted in compliance with applicable regulatory requirements and internal procedures.
  • Track validation deliverables and provide periodic progress reports to stakeholders
  • Author, review and/or approve applicable documentation such as specifications, SOPs, validation plans and reports, test protocols and reports
  • Executes/facilities gap analysis and/or risk assessments to ensure evaluation of current computer systems to ensure compliance with part 21 CFR Part 11, Annex 11, and GAMP 5.
  • Conduct impact assessments for changes impacting validated computerized systems. Acts as change owner for assigned projects
  • Act as subject matter expert during regulatory inspections
  • Provide coaching, training and/or mentoring to System Administrators, IT Technicians and Contractors

Your profile that will convince us: 

  • Bachelor’s Degree in Computer Science, Electrical Engineering, Chemical Engineering or other Technical Science with minimum 5 years experience in the field of pharmaceutical industry related to qualification and validation practices
  • Experience in planning, deploying, managing and sustaining computer system validations
  • Ability to manage validation and qualification activities and good business process understanding
  • Experience from ERP/SAP and MES systems is a strong advantage
  • Excellent command of English
  • Strong collaboration skills through international organizations and team player mindset

Our attractive benefits for you:

  • Wide range of tasks in an international setting, flexibility and personal responsibility
  • Reliable employer with generous employee benefits and a salary customary in the market.
  • Familiar setting of a family-owned enterprise with benefits such as Do & Co staff restaurant, extraordinary staff events and many more:

Additional information:

The minimum gross wage according to the collective agreement (chemical industry) for your new job is EUR 3.557,47. We strive to adapt your salary to your range of tasks and to your profile, which is why we are ready to pay wages higher than collectively agreed.

We are looking forward to new, committed employees who join forces with us to promote our strong growth in order to keep enabling our patients to live a better life – because it is in our blood! Is it in your blood too? We are looking forward to receiving your application via our online career portal.

Your contact:

Manfred Weinzerl, MSc
Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Straße 235, 1100 Wien,
T: +43 (1) 610 31 – 4515

About Octapharma

Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines.

Octapharma employs around 10,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Hematology, Immunotherapy and Critical Care.

Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 180 plasma donation centers across Europe and the US.

Fore more information, please visit www.octapharma.com

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Company Information
  • Total Jobs 43 Jobs
  • category Private Company
  • region A-Austria
  • full address Oberlaaer Straße
  • company-video
  • number of employees 8.300 global
  • branche Pharmazeutische Industrie
  • Foto credits (c) Octapharma

Branches

health, environmental and food sector, agriculture and forestry, pharmaceuticals, resource and environmental management, etc. All branches in a life science context.

Positions

Management, Research & Development, Sales, Administration, – all positions, which request know-how in bio-sciences.

fields of competences

Biochemistry, bioinformatics, biology, biotechnology, chemistry, data sciences, environmental technology, environmental science, food technology, forestry, agriculture, life sciences, mathematics, medicine, medical engineering, microbiology, molecular biology, natural sciences, nutritional sciences, pharmaceuticals, physics, psychology, statistics, resource and environmental management , process engineering, veterinary medicine, and comparable

Contact

life-science Karriere Services
E: web@life-science.eu
T: +43 (0)699 111 600 18
Wien / Vienna – Austria

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