Job Title: HVAC and Cleanroom Lead - Role Profile
Start Date: as soon as possible
Location: canton Bern
Task of the Job:
The main responsibilities of this position are:
- The position holder acts as the Client HVAC and Cleanroom Lead and is responsible and accountable within the Project Team and through BOD, Detailed Design, Construction, Commissioning, Qualification and Start Up for the process building GLB.
- This is a project role of duration 24 months, with an initial contract of 12 months.
- The position holder will also lead all aspects of a number of Coldrooms. Where Cleanroom is specified in the text below, it shall mean Cleanroom & Coldroom, where relevant.
- The position holder leads the HVAC Design and the Cleanroom Design.
Main Responsibilities and Accountabilities:
- Responsible and accountable for leading the Process design, inputting across the HVAC and Cleanroom-Design in accordance with the approved design, local codes, EHS- as well as cGMP regulatory requirements.
- Contributing to the delivery of the company strategy as well as supporting the financial CapEx budgeting process for the engineering and Project Management Organization.
- Coordinate with project Leads (Bulk, Fill Finish, Utilities, Warehouse, HVAC, Automation, Construction, etc...) in the project in order to assure overall coordination of the timelines and resources.
- Ensure that the Facility design intent is reflected within quality driven design deliverables and in accordance with the Project Brief, User Requirements, Local Authority conditions, Global Regulatory requirements and industry best practice.
- Support of the Maintenance Groups in the definition of the maintenance system and the maintenance schedule for the HVAC-systems and Cleanrooms.
- Responsible and accountable for working according to cGxP, health, safety and environmental requirements as laid out in the CSL SOPs and procedures as well as all relevant external / governmental guidance.
- Liaises with customer groups on the project to ensure delivery according to user requirements, process best practices, in accordance with quality and safety requirements.
- Responsible and accountable for all projects (engineering) requirements specifications, requirement specifications etc. dealing with the HVAC and Cleanrooms of the site.
- Technical support for procurement, FAT & SAT of all HVAC-equipment
- Active involvement in issue resolution, assisting cross-functional teams and attending coordination meetings between the various engineering disciplines leads to ensure smooth installation, construction and commissioning of the facility.
- Coordinate the design / construction / commissioning for HVAC and Cleanroom elements including equipment in order to ensure that the mechanical completion and commissioning are achieved in line with the master schedule and support the startup of interdependent functional areas.
- At least 10 years HVAC experience in Pharma or Chemical Industry to include Design, overseeing Installation and C&Q experience.
- Experience with Building Services including Sprinklers and HVAC utility requirement.
- ideally on a Life Sciences I Pharma I Biotech Upstream/Downstream/Finish manufacturing facility.
- Greenfield experience
- Knowledge of Energy recovery and BMS
- Experience in Operation and Maintenance of HVAC systems meet End User requirement
- Proven experience and knowledge in biotech, process and infrastructure engineering.
- Strong leadership experience gained within the design, procurement, construction & qualification environment of a recombinant Biotech manufacturing facility.
- Proven experience in cGMP, GLP & cGxP and qualification.
- Degree (Bachelor, Masters or higher) in HVAC, mechanical or Building Services engineering, Dipl. lng. or M.Sc. or B.Sc. or equivalent.
- German and Enqlish fluent in writing and spoken
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.