HVAC Validation Engineer

  • TG23937
  • Geel
Solliciteren

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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, on behalf of Sanofi, 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.

Profiel

We are looking for validation profiles with at least 5 years of experience in Qualification/validation
Knowledge of cGMP in a regulated environment is a must
Knowledge of the ISO 14644 standards is a must
The position requires daily interaction with other project team members (system owner, project engineer, …), so we are looking for team players with good communication skills.
Degree of Masters Qualification in Science or Engineering is a plus
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.

This includes:
Adhering to all applicable laws and regulations and Sanofi policies and procedures.
Being honest and treating people with respect and courtesy.
Constantly striving to make Sanofi a great place to work, respect for the quality of its people and products.
Acting as role models for our fellow employees by acting responsibly, fairly and honestly in our dealings and exercising sound judgment in performing our jobs.
Continuously looking for best practices and areas for improvement.

Basic Qualifications:
A minimum of 5 years' experience in a process or start-up role in the pharmaceutical industry.
Strong interpersonal, organizational, and technical skills.
Capability to work both independently and in a team environment.
Strong analytical and communication skills are required.
Strong Quality & Safety focus
Proficiency in Microsoft Office incl. Word, Excel, PowerPoint, Project and Visio.
Capable of leading teams to deliver results, including project management and KPI reporting
Excellent written and verbal presentation skills to support interactions with senior leadership and inspectors.

Preferred Qualifications:

Familiarity with applicable regulatory compliance requirements for biotech operations incl. area classifications etc.
Ability to read/interpret engineering drawings and design documents.
Management of medium to large size projects.
Excellent technical writing and verbal communication skills.
Knowledge of process & clean utility design
Knowledge of Validation Lifecycle Approach.
Strong mentoring and development experience.
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.
Understanding of Validation using risk-based approach
Demonstrated success working across organizations in highly cross-functional team environment.

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