As HVAC Validation Engineer you will be responsible for the qualification of designated HVAC systems.
You will guide a small team and be part of the larger ICV organization and you engage with various groups including design, construction, manufacturing, quality and engineering for the project.
You 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).
You write, review and approve validation & qualification protocols and reports, as well as execute protocols.
You 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.
You familiarize oneself with all elements of the HVAC design through documentation & drawing review with Construction Management Team and team members.
You will be a contact person for third parties related to HVAC and overseeing activities performed by third parties.
You will prepare and follow up a PQ and EQ sampling plan according to ISO standards, together with QC environmental monitoring and contamination control department.
You perform qualification activities in a GMP biotech manufacturing facility.
You provide technical assistance to less experienced technicians and engineers.
You review and approve qualification documentation (e.g. vendor test documentation/commissioning documentation) for assigned systems.
You approve protocol discrepancies and deviations.
You report, review, approve and follow up deviations and engage with technical support functions.
You participate in risk assessments and perform change controls.
You follow up on changes via the applicable project change control procedure in your own domain and communicate them to the relevant functions.
You report on progress - frequency as per requested by validation Lead.
Validation profiles with at least 5 years of experience in qualification/validation and preferably in a process or start-up role in the pharmaceutical industry.
Degree of Masters Qualification in Science or Engineering is a plus.
Demonstrated success working across organizations in highly cross-functional team environment.
Capable of leading teams to deliver results, including project management and KPI reporting.
Familiarity with applicable regulatory compliance requirements for biotech operations incl. area classifications etc.
Ability to read/interpret engineering drawings and design documents.
Must be able to establish strong working relationships with stakeholders (Commissioning, Manufacturing and MSAT) to ensure high quality deliverables meeting CGMP and site quality requirements.
Experience with the Kneat application is a plus.
Knowledge of (use) DeltaV / BMS is a plus.
Knowledge of cGMP in a regulated environment and knowledge of the ISO 14644 standards is a must.
Knowledge of process & clean utility design.
Knowledge of Validation Lifecycle Approach.
Strong interpersonal, organizational, analytical and technical skills.
Proficiency in Microsoft Office incl. Word, Excel, PowerPoint, Project and Visio.
Good technical writing and communication skills in English and knowledge of Dutch is a plus.
Strong quality and safety focus.
Capability to work both independently and in a team environment.