Group Lead Qualification Engineer

Octapharma

Group Lead Qualification Engineer at Octapharma leading qualification activities for technical systems across multiple sites. Collaborating with cross-functional teams to maintain compliance and improve operational efficiency.

Posted 5/22/2026full-timeVienna • 🇦🇹 AustriaSenior💰 €4,270 per monthWebsite

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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

Benefits

Comp & perks

Family values - Long-term perspective for employees and relationships
Be rewarded with an attractive salary and benefits package
Skills development - We offer various internal and external employee and leadership trainings, trainee programs and digital solutions

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

qualification activitiesIQ/OQqualification standardsprotocolsrisk assessmentschange controlsqualification efficiencyasset reliabilitytechnical guidancetroubleshooting

Soft Skills

collaborationindependencecommunicationtechnical supportproblem-solvingtrainingproject managementleadershipcross-functional teamworkorganizational skills