Inova is a Swiss consulting and engineering firm specializing in supporting life sciences industries through high‑value expertise in quality, compliance, engineering and digital transformation. We help our clients maintain reliable, compliant and efficient manufacturing systems throughout their operational lifecycle.
Position Overview GMP Manufacturing Systems Owner
Company:
Inova (www.inova-sa.ch)
Location:
Switzerland
Contract Type:
Full‑time – On‑site
Start Date:
ASAP
About Inova Inova is a Swiss consulting and engineering firm specializing in supporting life sciences industries through high‑value expertise in quality, compliance, engineering and digital transformation. We help our clients maintain reliable, compliant and efficient manufacturing systems throughout their operational lifecycle.
Job Description We are seeking an experienced System Owner Support – Manufacturing Systems to support a pharmaceutical manufacturing site in Switzerland. The site’s Manufacturing System Owner is currently managing a high volume of documentation approvals, change controls, deviations, and system lifecycle activities, resulting in delays across critical manufacturing system processes. In this role, you will act as a deputy to the Manufacturing System Owner and take ownership of a significant portion of the operational and documentation workload across multiple manufacturing systems. You will review and approve documentation, manage changes and deviations, and verify that implemented system functionalities remain aligned with the approved User Requirements Specifications. This position requires extensive hands‑on experience in the ownership and lifecycle management of manufacturing systems such as MES, SCADA, Factory Layer, and related production applications.
Key Responsibilities
Act as deputy System Owner across multiple manufacturing and production systems
Perform documentation reviews and approvals on behalf of the Manufacturing System Owner
Manage change controls related to manufacturing systems from initiation through implementation and closure
Coordinate and manage system‑related deviations, investigations, corrective actions, and follow‑up activities
Assess the impact of proposed system changes on validated status, production activities, and GMP compliance
Verify that implemented system functionalities remain aligned with the original and approved User Requirements Specifications
Review system lifecycle, validation, operational, and quality documentation
Ensure that system documentation is complete, accurate, traceable, and inspection‑ready
Support the prioritization and resolution of documentation and approval backlogs
Coordinate with Manufacturing, Automation, IT, Engineering, QA, Validation, and external system suppliers
Support periodic reviews, access reviews, system assessments, and other lifecycle activities
Monitor open actions, deviations, changes, and documentation deliverables across assigned systems
Escalate compliance, operational, or delivery risks to the Manufacturing System Owner and relevant stakeholders
Support audits and regulatory inspections involving manufacturing systems
Profile Requirements
Degree in Engineering, Computer Science, Automation, Life Sciences, or a related discipline
Minimum 10 years of experience working with manufacturing systems in a pharmaceutical, biotechnology, or regulated production environment
Significant experience with systems such as MES, SCADA, Factory Layer, automation platforms, or comparable manufacturing applications
Previous experience as a System Owner, Business System Owner, Technical System Owner, or deputy owner for multiple manufacturing systems
Strong understanding of system ownership responsibilities throughout the computerized system lifecycle
Solid command of GMP documentation requirements
Extensive experience managing change controls and deviations
Ability to review system functionalities against approved User Requirements Specifications
Good understanding of computerized system validation, data integrity, and validated system maintenance
Ability to independently review, challenge, and approve complex technical and quality documentation
Strong organizational skills and the ability to manage a high volume of concurrent activities
Autonomous, reliable, and delivery‑focused working style
Strong communication and stakeholder coordination skills
Fluent English required
Why Join Inova
Take a central role in supporting the lifecycle management of critical manufacturing systems
Work across multiple MES, SCADA, automation, and shop‑floor applications
Help improve approval timelines and reduce operational documentation backlogs
Collaborate with experienced manufacturing, quality, automation, and IT teams
Join a company that values technical expertise, accountability, and pragmatic delivery
Inova is an equal opportunity employer. We welcome diverse perspectives and are committed to fostering an inclusive workplace.
#J-18808-Ljbffr
Position Overview GMP Manufacturing Systems Owner
Company:
Inova (www.inova-sa.ch)
Location:
Switzerland
Contract Type:
Full‑time – On‑site
Start Date:
ASAP
About Inova Inova is a Swiss consulting and engineering firm specializing in supporting life sciences industries through high‑value expertise in quality, compliance, engineering and digital transformation. We help our clients maintain reliable, compliant and efficient manufacturing systems throughout their operational lifecycle.
Job Description We are seeking an experienced System Owner Support – Manufacturing Systems to support a pharmaceutical manufacturing site in Switzerland. The site’s Manufacturing System Owner is currently managing a high volume of documentation approvals, change controls, deviations, and system lifecycle activities, resulting in delays across critical manufacturing system processes. In this role, you will act as a deputy to the Manufacturing System Owner and take ownership of a significant portion of the operational and documentation workload across multiple manufacturing systems. You will review and approve documentation, manage changes and deviations, and verify that implemented system functionalities remain aligned with the approved User Requirements Specifications. This position requires extensive hands‑on experience in the ownership and lifecycle management of manufacturing systems such as MES, SCADA, Factory Layer, and related production applications.
Key Responsibilities
Act as deputy System Owner across multiple manufacturing and production systems
Perform documentation reviews and approvals on behalf of the Manufacturing System Owner
Manage change controls related to manufacturing systems from initiation through implementation and closure
Coordinate and manage system‑related deviations, investigations, corrective actions, and follow‑up activities
Assess the impact of proposed system changes on validated status, production activities, and GMP compliance
Verify that implemented system functionalities remain aligned with the original and approved User Requirements Specifications
Review system lifecycle, validation, operational, and quality documentation
Ensure that system documentation is complete, accurate, traceable, and inspection‑ready
Support the prioritization and resolution of documentation and approval backlogs
Coordinate with Manufacturing, Automation, IT, Engineering, QA, Validation, and external system suppliers
Support periodic reviews, access reviews, system assessments, and other lifecycle activities
Monitor open actions, deviations, changes, and documentation deliverables across assigned systems
Escalate compliance, operational, or delivery risks to the Manufacturing System Owner and relevant stakeholders
Support audits and regulatory inspections involving manufacturing systems
Profile Requirements
Degree in Engineering, Computer Science, Automation, Life Sciences, or a related discipline
Minimum 10 years of experience working with manufacturing systems in a pharmaceutical, biotechnology, or regulated production environment
Significant experience with systems such as MES, SCADA, Factory Layer, automation platforms, or comparable manufacturing applications
Previous experience as a System Owner, Business System Owner, Technical System Owner, or deputy owner for multiple manufacturing systems
Strong understanding of system ownership responsibilities throughout the computerized system lifecycle
Solid command of GMP documentation requirements
Extensive experience managing change controls and deviations
Ability to review system functionalities against approved User Requirements Specifications
Good understanding of computerized system validation, data integrity, and validated system maintenance
Ability to independently review, challenge, and approve complex technical and quality documentation
Strong organizational skills and the ability to manage a high volume of concurrent activities
Autonomous, reliable, and delivery‑focused working style
Strong communication and stakeholder coordination skills
Fluent English required
Why Join Inova
Take a central role in supporting the lifecycle management of critical manufacturing systems
Work across multiple MES, SCADA, automation, and shop‑floor applications
Help improve approval timelines and reduce operational documentation backlogs
Collaborate with experienced manufacturing, quality, automation, and IT teams
Join a company that values technical expertise, accountability, and pragmatic delivery
Inova is an equal opportunity employer. We welcome diverse perspectives and are committed to fostering an inclusive workplace.
#J-18808-Ljbffr
GMP Manufacturing Systems Owner Arbeitgeber: Inova Consulting
Inova ist ein hervorragender Arbeitgeber, der Ihnen die Möglichkeit bietet, eine Schlüsselrolle in strategischen Industrieintegrationsprojekten zu übernehmen. Mit einem Fokus auf Präzision, Autonomie und Zusammenarbeit fördert Inova eine positive Arbeitskultur, in der Sie mit erfahrenen Projekt-, Ingenieur-, Automatisierungs- und Qualitätsteams zusammenarbeiten können. Zudem profitieren Sie von umfangreichen Entwicklungsmöglichkeiten in einem dynamischen Umfeld, das sich auf die Zukunft der Lebenswissenschaften und Industrie konzentriert.
