Job-description Vacatures in Tilburg

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Are you ready to advance your career with a world-class team At Thermo Fisher Scientific we seek an ambitious highly skilled Validation Engineer II for our validation department in Tilburg. You will ensure flawless execution of equipment utilities facilities qualification and process validation activities. You will work closely with technical development quality and production teams to meet world-class validation standards.

Job Description :

Proven hands-on experience in Commissioning & Qualification and Validation gained in a highly regulated environment within a pharmaceutical setting or equivalent

Demonstrates expertise in crafting new equipment changing processes growing production and successfully implementing new products

Co-drafts User Requirement Specifications (URS) with suppliers and the multi-disciplinary team

Drafts validation plans and performs implementation of protocols for C&Q / IQ / OQ / PQ related to equipment utility facilities including final reports and advice on periodical review frequencies

Ability to extract information from systems and generate Periodic Review Reports for critical equipment / utilities / processes including Continued Process Verification (CPV)

Provides validation technical support within other departments

Drafts reviews and amends procedures Validation Master Plan and other validation audited documents

Responsible for ensuring the validated status of all cGMP-critical automated process applications and quality systems

Remains abreast of current developments and regulations for the pharmaceutical industry

Acts as a validation SME for internal and external audits

Qualifications requirements :

Preference for candidates with a bachelors degree or equivalent experience in technology science or a related field and a willingness to learn. Prior experience in validation GMP or pharmaceutical manufacturing is required. This role offers an outstanding opportunity for learning and growth in various areas.

Personal :

Integrity Intensity Innovation and Involvement are core characteristics we expect of all members of our organization. If you enjoy leading change and working within a matrix organization to improve internal processes you will discover happiness in this role!

Key Skills

Python,SOC,Debugging,C / C++,FDA Regulations,Minitab,Technical Writing,GAMP,OS Kernels,Perl,cGMP,Manufacturing

Employment Type : Full-Time

Experience : years

Vacancy : 1