Jobs

Validation Engineer

Discipline
Engineering
Sector
Life Science
Location
Belgium
Vacancy ID
57285

Responsibilities

  • As Validation Engineer you will be responsible for the qualification of designated systems (both utility and process).
  • 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 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 process & utility design for assigned systems through documentation & drawing review with Construction Management Team and team members.
  • You engage with the Commissioning Management Team to perform and document qualification activities as P&ID Walk Downs.
  • You perform qualification activities in a GMP biotech manufacturing facility.
  • You provide technical assistance to less experienced technicians/engineers.
  • You review and approve qualification documentation (e.g. vendor test documentation/commissioning documentation) for assigned systems.
  • You resolve protocol discrepancies and deviations.
  • You report, review and approve deviations and engage with technical support functions.
  • You participate in risk assessments and perform change controls.
  • You follow up changes via the applicable project change control procedure in your own domain and communicate them to the relevant functions
  • You will oversee activities performed by third parties.
  • You report on progress - frequency as per requested by validation Lead.

Requirements

  • Validation profiles with at least 3 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.
  • Understanding of validation using risk-based approach.
  • 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.

Let us handle the details

We at STAR are happy to take care of the details

01 // Education and development

Standing still in this fast-changing market is not an option. That's why you can combine this position at STAR with courses to further your specialist knowledge and skills. It's the best of all worlds: work, learn and be part of a challenging project all at the same time. Whether you need a springboard to launch your career or simply want to update your expertise, the training programmes offered by our STAR Academy ensure that your qualifications are always in line with your ambitions.

// Apply

Now it's your time to shine

Full speed ahead · Full speed ahead ·

Get in touch with our Consultant Nele

We've got more

View all jobs

Drop your resume in two clicks

View all jobs
// Get in touch

Drop your resume & chat

Drop your resume once and we'll find you the best project that fits you. Good enough is not enough for us. We go the extra mile

Full speed ahead · Full speed ahead ·

Get in touch with our Consultants