Tipo di lavoro: Full-time

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Contenuto del lavoro

Job Title:HVAC / Utilities Engineer

Job Description:YOUR MISSION :
The HVAC / Utilities Engineer will interface between end user, technical staff and suppliers for all HVAC / Utilities systems. The Engineer is also in charge of managing external contractors during projects, preventive/corrective maintenance and qualification activities.
YOUR RESPONSIBILITIES:
  • Control and ensure HVAC / Utilities Engineering & Maintenance tasks according to building concepts, legal requirements, technical standards and GMP regulations
  • Assure the complete functionality of HVAC / Utilities systems
  • Support all colleagues for all other Facilities / Utilities systems
  • Perform the preventive and corrective maintenance on HVAC / Utilities installations ensuring that the maintenance meets business and quality requirements
  • Follow all interventions in GMAO system
  • Ensure validation / qualification / calibration status in line with cGMPs, 21 CFR Part 11 and GAMP5 for all HVAC systems and PLCs
  • Write related qualification protocols and reports, coordinate and execute qualification
  • Perform periodic evaluation for HVAC / Utilities systems qualified state; apply and implement related Corporate and ICH guideline
  • Follow and implement updates of the systems according to GAMP and Switzerland rules
  • Update the technical and validation documentation after modifications on systems
  • Establishment and up-date of SOP’s, CML, MML, technical standards for projects and FM and according to the C-SOP
  • Supervise and Manage external suppliers
  • Ensure efficient link between Production P3E, Product Supply and administration (HQ) teams
  • Responsible for opening, follow-up on handling of deviation, CAPA and Change Control according to applicable procedure
  • Responsible to propose improvement/correction from trending on deviation, CAPA, change control
  • Support industrial projects. This can include new Utilities/Facilities systems and modification of current Utilities/Facilities systems
  • Communicate the Safety Health and Environment Policy in line with EHS Policy (waste selective improvement, energy and water consumption, ergonomics at workplace, EHS Event and near miss records). Respect of these EHS rules
  • Participe to the ‘’Service de Piquet’’ for all Utilities / facilities / building installations
Projects:
  • Part project leading as a subject matter expert and monitoring of HVAC tasks including design phase, execution, commissioning, etc..
  • Prepare and manage project scope, budget, resource needs, economical evaluation and timeline (Use Project Manual)
  • During execution, ensure that projects meet business as well as quality requirements
  • Identify and manage project risks
  • Ensure efficient link between operation & Engineering team, define and contribute to projects selection
  • Up-date the technical documentation after modification on Utilities systems
REQUIRED EXPERIENCE & COMPETENCES:
  • Mechanical / CVS Engineer or related disciplines (HES, BTS or equivalent)
  • Minimum 3 to 5 years experience in the Pharmaceutical or Chemical industry / Engineering
  • Background / good knowledge in black & clean Utilities systems
  • Good knowledge in Autocad LT software and Oracle GMAO system
  • Good knowledge in Siemens S7, Desigo Insight
  • Pharmaceutical experience on documentation during project and operation phases strongly recommended
  • Management of external resources and Project Management
  • Ability to take decisions and work independently
  • Several years of experience in the field of the maintenance and in the exploitation of Pharmaceutical Utilities
  • Experience in cGMP subjects & Facility and in implementing GMP facilities
  • Mother tongue/Fluent in French and Technical English
  • Strong understanding of cGMPs
  • Autonomy in the daily business
  • Good verbal communication and communication skills (incl. English)
  • Able to make quality decision on time
Location:Switzerland SMP - St Prex
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Scadenza: 10-05-2024

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