association ARQHA « Agence Régionale pour la Qualité et l'Hygiène Alimentaire »
Swisslinx AG
Plant Engineer
Descrizione del posto
For our client, we are seeking a Plant Engineer to provide engineering expertise, support and continuously improve site operations, and ensure reliable, compliant production in line with cGxP standards.
Plant Engineer
Job description:
As a Plant Engineer, you will provide engineering expertise to support and continuously improve site operations, ensuring reliable and compliant production in line with cGxP standards. You will play a key role in maintaining and optimizing facilities and utilities systems while supporting cross-functional projects across the site.
In this role, you will directly contribute to the reliability, safety, and performance of a highly regulated production environment, ensuring continuous operations and supporting the delivery of high-quality products to patients.
- Act as Subject Matter Expert (SME) for assigned facilities and utilities systems, serving as the main technical contact
- Provide expertise across building systems, HVAC, black utilities (e.g. chillers, boilers), clean utilities, and chemical storage & distribution
- Support and lead investigations, troubleshooting, and resolution of recurring technical issues
- Drive continuous improvement, optimization, and modification of equipment and installations
- Contribute to the design, installation, commissioning, and qualification (IQ/OQ/PQ) of systems and upgrades
- Ensure equipment and systems remain fit for use, proactively identifying risks and implementing corrective actions
- Coordinate and execute maintenance improvements, upgrades, and engineering changes
- Ensure full compliance with cGMP, GEP, safety, and industry standards (e.g. SUVA/ASIT)
- Develop and implement engineering procedures and best practices
- Support the execution of site, divisional, and corporate standards and processes
- Participate in internal and external audits as a technical expert
- Contribute to engineering projects of varying complexity across site operations
About the customer:
A leading global biopharmaceutical company focused on developing and delivering innovative therapies for patients worldwide, with a strong presence in advanced biologics manufacturing and a commitment to high-quality standards and continuous improvement.
Requirements:
- Degree in Engineering (BSc/MSc or equivalent), preferably in Biotechnology, Chemistry, Food Processing, Mechanical Engineering, or a related field
- Minimum 5 years of experience in the pharma or biotech industry, within process, plant, or engineering environments
- Proven experience in the installation, commissioning, and validation of pharmaceutical facilities, with a strong focus on Facilities & Utilities
- Experience in maintenance and utilities systems is a strong advantage
- Proficient in MS Office and MS Project
- Solid knowledge of Good Engineering Practices (GEP), cGxP, FDA, ISPE, ASTM E2500 and ASME/BPE standards
- Strong problem-solving skills with a hands-on, solution-oriented mindset
- Comfortable working in a fast-paced, highly regulated environment
- Team-oriented, proactive, and action-driven approach
- Eagerness to continuously learn and develop technical expertise
- Willingness to be hands-on and close to operations
- Fluent in French and English (spoken and written); German is a plus
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