Validation Engineer

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.