Experienced Plant Engineer - #47897

Founded in 1968, SKAN is a pioneer in cleanroom equipment and the development of isolators for the pharmaceutical industry. Innovative products, tailor-made solutions and an effective service organisation have made SKAN a market leader and a key partner to industry and research laboratories
Overview
To support the development of our newly established subsidiary “maeven AG,” we are seeking an experienced professional with expertise in equipment qualification and CSV within the GxP pharmaceutical environment. In this role, you will be responsible, among other things, for implementing and executing the qualification strategy for our process equipment. Your responsibilities will also include overseeing and coordinating FATs as well as preparing the necessary qualification documentation. You can expect to join a dynamic and dedicated team. In this role, you will make a decisive contribution to the successful completion of our projects
Responsibilities

• Establishing new processes and equipment in the field of sterile manufacturing and its infrastructure
• Specifying new systems and components
• Supporting operational readiness
• Ensuring the technical availability of production and infrastructure facilities in accordance with applicable regulations (cGMP, safety), including spare parts management
• Ensuring and overseeing the performance of calibrations, maintenance, and support for the qualification of production and infrastructure facilities, such as isolator filling systems, autoclaves, ventilation systems, and ultrapure water systems
• Supporting regulatory and customer inspections
• Coordinating and supervising external and internal service providers
• Continuously improving system availability, including updating and reviewing system documentation, as well as implementing corrective and proactive measures
• Processing change requests and deviation reports
• Potential on-call duty

Hardskills

• Bachelor’s or Master’s degree in engineering (mechanical engineering/process engineering, automation/systems engineering, chemistry, biology, pharmaceutical engineering, computer engineering), or equivalent technical training
• Extensive experience in a GMP environment (ideally in sterile/aseptic production)
• Experience in project management and the implementation of new equipment/processes
• Proficiency in working with systems such as Kneat and control systems
• Business-level English proficiency; German skills are a plus

Softskills

• Strong problem-solving skills and ability to work independently
• High standards of quality (with a focus on patient safety)
• Open communication and the ability to collaborate within a dynamic team
• Competent and professional demeanor when interacting with clients and government agencies
• Precise and meticulous work ethic

We offer you

• An open and collaborative corporate culture
• Freedom to contribute and develop ideas
• Opportunities to participate in sports and social activities
• Professional development and continous learing opportunities, especially at our SKAN Academy
• Comprehensive and career-focused onboarding
• Quick decision-making paths and flat hierarchies
• Transparent and open communication
• 5 weeks of vacation, with the option to take additional leave

Additional information
We look forward to receiving your complete application documents (CV, diplomas and employment references) via our career page.
For this position, we are focusing on direct applications and are not working with external agencies. Any dossiers submitted by agencies will not be processed
For questions please contact Viviane Braxton