HVAC validation engineer

Functieomschrijving

The HVAC Validation Engineer will be responsible for the qualification of designated systems. The role will involve guiding a small team, as well as part of the larger ICV organization and engaging with various groups including design, construction, manufacturing, quality & engineering for the project.

The role of the HVAC validation engineer will be one of direct responsibility for the successful qualifications of the HVAC systems in scope of the project.

Reporting to the validation Lead or manager, the role of the HVAC Validation engineer will be as follows:

Core responsibilities:

• Plan and coordinate the qualification of HVAC systems (HEPA filter integrity test, air speed velocities, air changes, particle counting and classification of clean rooms and decontamination time according to ISO 14644 standards, measurement of temperature, relative humidity, differential pressure, microbiological tests of air and surfaces)
• Write, review and approve Validation & qualification protocols and reports, as well as execute protocols.
• Work together with a small team of start-up personnel (incl. engineers, mechanical craft persons, E&I technicians, etc.) and sometimes alone, to successfully execute qualification activities safely and to a high quality, based on the overall ICV schedule, for assigned systems.
• Familiarize oneself with all elements of the HVAC design. This to be achieved through documentation & drawing review with, Construction Management Team & Sanofi team members.
• Contact person for third parties related to HVAC and overseeing activities performed by third parties.
• Set up PQ and EQ sampling plan according to ISO standards, together with QC environmental monitoring and contamination control department and follow up on PQ and EQ sampling.
• Perform Qualification activities in a GMP biotech manufacturing facility
• Provide technical assistance to less experienced technicians/engineers.
• Review/approve Qualification documentation (e.g. vendor test documentation/commissioning documentation) for assigned systems
• Resolve protocol discrepancies and deviations.
• Generate, review and approve deviations
• Report & follow up on deviations, solving technical problems
• Participate in risk assessments
• Perform change control assessment
• Follow-up of changes via the applicable project change control procedure
• Follow up on changes in own domain and communicate them to the relevant functions
• Overseeing activities performed by third parties
• Engage with technical support functions (e.g. process, automation etc.) to resolve issues quickly as they arise through commissioning execution.
• Report on progress - frequency as per requested by validation Lead.

Jouw profiel

• 5 years of experience in Qualification/validation
• Knowledge of GMP in a regulated environment is a must
• Degree of Masters Qualification in Science or Engineering is a plus
• Knowledge of the ISO 14644 standards is a must
• Knowledge of English is a must, knowledge of Dutch is a plus.
• Experience with the Kneat application is a plus
• Knowledge of (use) DeltaV / BMS is a plus
• Responsible for qualification activities related to one or more of the following areas: DQ, IQ, OQ, PQ, and EQ activities for HVAC utilities.

Wij bieden jou

In addition to a contract of indefinite duration with an attractive tailor-made salary, we offer you:

• meal vouchers of 8 euros per day worked;
• flat-rate reimbursement of expenses;
• company car and fuel card;
• hospitalisation and group insurance;
• eco-cheques with a max. of 250 euros per year;
• the chance to build a large network;
• the opportunity to share your experience and knowledge with other TEC consultants

Over ons

We are TEC, your strategic partner for engineering projects in the construction sector, industry, pharmaceuticals, (petro)chemistry, IT and telecom. Our mission? Creating added value for our customers. With us, passion, integrity, teamwork and creativity are paramount. Thanks to our extensive network and years of recruitment experience, we offer interesting jobs tailored to your expertise and expectations. Our team is ready for an excellent follow-up! In this way we guarantee an exciting and pleasant working environment for all our consultants.