Quality Engineer (f/m/d)

Avantor is looking for a meticulous and committed Quality Engineer to join our Quality Projects team at our key site in Gliwice. If you have experience in process validation, quality documentation, and want to make a real impact on product quality in the pharmaceutical, biotech, and research industries – this role is for you!

• Preparation & Execution of internal validation documentation.
• Reviewing & Approval of external qualification documentation.
• Contribute to the creation of Comparative Study Reports, Cause & Effects Matrix and Failure Modes Effects Analysis.
• Determination of Critical Process Parameters and Critical Quality Attributes. 
• Training operating personnel and teams involved in validation execution.
• Reviewing any deviations, CAPA’s, or amendments applicable to the validation documentation. 
• Reviewing all manufacturing and testing records for the completed lots under validation effort. 
• Support as subject matter expert during customer and regulatory inspections, reviews, and on-site meetings.
• Contribute to the creation of SOP's and or instructions in the area of responsibility.
• Support with Quality initiatives/investigations/risk assessments.
• Working in compliance with the current good manufacturing practices.
• Electronic data entry as well as updating and distribution of forms in the area of responsibility.
• Developing, modifying, applying, and maintaining quality evaluation and control systems/protocols.
• Providing technical and quality operations support to other departments.
• Developing, and analyzing trends to improve quality and continuous improvement.
• Performing other duties as assigned.

• Degree in Engineering or related discipline.
• Fluent English and Polish language skills (min. level of B2).
• Validation & Qualification Experience knowledge.
• Knowledge of statistical data analysis.
• Quality Management Systems knowledge (ISO 9001 / ISO 13485, 21 CFR 210 & 211, 21CFR 820 and GMAP 5) is nice to have.
• Good Manufacturing Practice knowledge.
• Very good working knowledge of MS Office.
• High level of organizational skills and attention to detail.
• Experience in quality assurance is preferred.
• Experience in chemical manufacturing or the pharmaceutical industry is preferred.

#LI-Onsite

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.
 
The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.
 
We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

EEO Statement:

We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at recruiting@avantorsciences.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

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By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.