Scientist - QC Validations

At Avantor, people are the most important part of our success because they drive our global performance. Thats why our Operations, Lab Services, Sales, and many other Avantor teams rely on our talent acquisition initiatives to attract, engage and hire the right talent. Avantors Quality Control & Validation vertical is a crucial part of this mix, enabling all our internal teams worldwide to grow beyond their limits.

Under general supervision, the Scientist QC Validation person will qualify and validate equipment, instruments, and systems. Develop validation plans, protocols, and testing specifications. Analyze validation reports and make recommendations for changes and/or improvements. Assist in the selection of equipment and systems and negotiate competitive pricing. Work with regulatory agencies on inspections.

What were looking for:

• Education: Bachelors degree in Chemistry, Biochemistry or science related field
• Experience: 5 years of applicable experience in analytical methods validation

Who you are:

• Familiarity with MS Office (Word, Excel, Access)
• Strong interpersonal and organizational skills
• Ability to work in a team environment
• Ability to analyze, investigate and propose approaches to technical and regulatory issues
• Ability to design, execute and analyze analytical method validation studies
• Ability to manage multiple concurrent tasks/studies
• Ability to identify, analyze and resolve problems that may be complex in nature
• Strong attention to detail
• Strong communication skills

How you will thrive and create an impact:

• Develops and writes analytical method validation protocols in the QC laboratory. Ensures the laboratory method validation meet requirements for medical device or regulated products.
• Executes method validation protocols, and summarized execution of method validation activities in a written report. Creates and writes laboratory methods for use in routine laboratory testing.
• Coordinate and align resources for method validation testing.
• Assure laboratory personnel are properly trained for validation activities where appropriate.
• Understands governing principle of method validation for analytical methods ICH Q2 R1, USP , USP and regulations 21CFR820, 21CFR 210 & 211.
• Assist with selection and purchase of laboratory instruments for the QC laboratory.
• Writes and/or executes laboratory instrument qualifications, IQ, OQ and PQ when required.
• Prepare and implements SOPs, methods, protocols and other laboratory documentation as necessary and appropriate.
• Complete validation work in an appropriate and timely manner to meet the needs of the protocols, customer and company requirements.
• Work together with Operations, Validations, Product Design & Engineering and other relevant departments to develop validation strategies for new or existing products
• Understand the analytical laboratory equipment capabilities. Proactively maintain current industry and regulatory knowledge for method validation, GMP principles and medical devices.
• Performs other duties as assigned.

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.

For more information about equal employment opportunity protections, please view the Know Your Rights poster .

3rd Party Non-Solicitation Policy:

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.