Validation Engineer II, Production Equipment & Utilities GMP

Work Schedule

Environmental Conditions

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 production equipment(hardware) and utilities (HVAC, purified water, nitrogen, compresses air), 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 bachelor's 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!