Key Responsibilities:
Serve as the primary contact (Subject Matter Expert - SME) for users of assigned installations regarding technical aspects, including HVAC systems, Water Systems (WFI), Cooling systems and loops, Chillers, Process Gases, and Building Utility Systems (all critical GMP utilities).
Actively participate in investigations, deviations, and CAPAs related to quality and EHS, ensuring compliance with cGMP, GEP, SUVA / ASIT, etc.
Lead and/or support the design and qualification of improvements, changes, or upgrades to equipment and plant facilities. Monitor, evaluate, and approve supplier interventions for functional unit (FU) equipment.
Ensure all engineering work packages are delivered according to the project schedule.
Proactively challenge over-engineered design solutions.
Review and approve design deliverables.
Manage scope, risk, and stakeholder engagement within his/her work scope.
Be responsible for the project management of his/her backup organization.
Respect the escalation process.
Contribute effectively to the portfolio lifecycle management policy.
Key Requirements:
Knowledge of a GMP environment.
Engineering degree (BS, MS, or equivalent) in mechanical, automation/technical engineering, biotechnology, or related sciences (chemistry, physics, etc.).
At least 5 years of experience in the Pharma, Biotech, Chemical, or Energy industries.
Strong organizational and communication skills.
Project management experience.
Fluent in French and English (spoken and written); German is a plus.
PLC/Automation programming experience (Siemens, Johnson Controls, or Allen Bradley) is a plus.
Proficient in MS Office products.
Holds an EU passport or valid Swiss work permit.
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