Group Lead Qualification Engineer (m/f/d)

Job-ID: 61419
Location: Wien, AUT; Lingolsheim, FRA; Springe, DEU; Stockholm, SWE
Job Level: Professionals
Category: Technical
Employment Type: Permanent position

Become part of a vital chain and contribute to our common goal of making people's lives better. Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing medicines sourced from human plasma and human cell lines. We are a privately-owned company, where the warmth of family meets the scale of a global organisation.

Join us in shaping our vision to provide new health solutions advancing human life.

We are seeking a motivated and detail-oriented Group Lead Qualification Engineer to join the Group Technical Unit. In this role, you will lead and coordinate qualification activities for equipment, facilities, utilities, and technical systems across multiple sites. You will ensure that technical assets are installed, operated, and performing in accordance with company standards, regulatory expectations, and operational requirements. The position plays a key role in supporting global engineering projects, standardization initiatives, and continuous improvement programs throughout the organisation.

You will collaborate closely with various group functions, local qualification departments, project teams, and external suppliers to ensure alignment with company standards for capacity, efficiency, and operational excellence.

The position can be based in Vienna (Austria), Stockholm (Sweden), Lingolsheim (France) or Springe (Germany).

The position is part of the Group Technical Organization and reports directly to the Head of gTO.

Your main tasks and responsibilities

• Plan, execute, and oversee qualification activities, including IQ/OQ for systems and facilities
• Support the Group Technical Unit in global and multi-site engineering projects, expansions, and upgrades
• Develop and maintain qualification standards, templates, protocols, and reporting systems
• Coordinate and support the qualification of production equipment, utilities, automation systems, and infrastructure
• Review qualification documentation, deviation reports, risk assessments, and change controls
• Ensure compliance with internal engineering standards and applicable regulations, including GMP, ISO, FDA, and safety requirements
• Work closely with site engineering, maintenance, production, quality, and project teams
• Support troubleshooting and root cause investigations related to technical systems or failed qualifications
• Drive harmonization of qualification practices across multiple company locations
• Provide technical guidance and training to local engineering teams
• Identify opportunities to improve qualification efficiency and asset reliability

Your expertise and ideal skill set

• University degree in a technical field
• 5+ years of experience in qualification, validation, technical engineering, or manufacturing support
• Strong knowledge of IQ/OQ/PQ and lifecycle qualification principles
• Experience working with manufacturing equipment, utilities, or facility systems
• Experience in the pharmaceutical manufacturing industry
• Understanding of and experience with engineering development models and the preparation of related design documentation
• Ability to act independently while also collaborating effectively with cross-functional teams

Thrive with us

• You help save lives - Every day is meaningful as we produce life-saving medicines
• Family values - Long-term perspective for employees and relationships
• Be rewarded with market-related salary and benefits package
• You will have a high level of influence where you can make a difference and leave your footprint
• Work with skilled and fun colleagues in a relatively informal organization
• Skills development - We offer various internal and external employee and leadership trainings, trainee programs and digital solutions

It´s in our blood

We live diversity and stand for equal opportunities as an employer! We therefore look forward to receiving your application - regardless of age, gender, origin, sexual orientation, and religion.
Please apply in English.

Do you have any questions? Then get in touch with your contact person.

Mrs. Larissa Amling (Responsible Recruiter)
larissa.amling@octapharma.com

Additional information (Austria only):

The minimum gross wage according to the collective agreement (chemical industry) for your new job is EUR 4.270,14. 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. This is a legal requirement in Austria which is not applicable for other sites.

About Octapharma

Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. We employ more than 11,000 people worldwide to support the treatment of patients in 120 countries with products across three therapeutic areas: Immunotherapy, Haematology and Critical Care. With seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany, and Sweden, Octapharma also operates over 195 plasma donation centres across Europe and the US. With four decades of experience, we are committed to advancing patient care worldwide.

Apply now