Sr. Validation Engineer

The Opportunity :

Avantor is looking for a Sr. Validation Engineer to provide specialized knowledge in developing the strategy for equipment for processes and works with the validation team to ensure proper installation operational and performance qualification of each piece of equipment up to and including all associated documentation. This includes products for medical device excipient and bio-pharma manufacturing. Prepares all protocols and reports for validation work. Coordinates all validation activities by constant communication with affected departments and personnel; oversees and reviews validation area processes and procedures.

The Sr. Validation Engineer is responsible for the theory and content of validation documents for equipment processes systems software changes and on-going review and revalidation of said items to ensure that validation documentation is compliant with validation requirements and policies. Provides facility equipment and process qualification technical expertise. Author validation documents and execute validations of equipment control systems and production processes. Directs the life cycle of launched products to support development of manufacturing processes drive right-first time metrics and reduce product rejects. Has responsibility for self-identification of process optimization opportunities and detailed assessment of opportunities (process risk financial cost / benefits etc.). Participates in cross-functional assessments as required to evaluate optimization opportunities / issues. Coordinate and lead validations to assure compliance with customers requirements ISO 9001 &CFR 210 & 211 21CFR 820 ICH Q7 and IPEC for all departments within Avantor.

This role will be a hybrid position based out of our Solon Ohio facility (or near other Avantor sites - St. Louis Kentucky Phillipsburg NJ) with 25% travel for projects.

What were looking for :

Education : BS degree in Engineering or Life Science (Chemistry Bio Physics etc.) preferred

Experience : 5 years of experience in an Equipment Cleaning and / or Process Validation Engineering experience within a pharmaceutical or medical device company

Knowledge of Industrial Quality Control Quality Engineering Quality Assurance and Validation CFRs and their application to Medical Devices

Knowledge of software packages supporting statistical data analysis word processing flow charting and project management

Familiarity and understanding of manufacturing methods related to the production of medical devices and related products

Familiarity and understanding of technical disciplines related to Quality Control including Engineering and process controls

Strong communication skills both verbal and written; ability to work and interface with all levels

Use of computers and peripherals related to validation execution and document authoring

Ability to work independently and as a team member as well as with Consultants / Contractors to achieve projects validation objectives

Ability to analyze investigate and propose approaches to technical and regulatory issues

Ability to manage multiple concurrent tasks / studies

Ability to execute the Validation Plans for medical device and related product manufacturing equipment and facilities

Ability to travel to other sites.

How you will thrive and create an impact :

Interface effectively with management personnel in IT Engineering Quality R&D Sales and other technical disciplines.

Provide technical decision making regarding validation strategies and requirements for large scale and complex projects.

Author and approve validation plans validation protocols risk assessments traceability matrices validation reports and other documents supporting validation for new and existing manufacturing equipment and processes.

Perform coordinate and manage qualification testing.

Represent Company in contacts with regulatory agencies including interface with FDA inspectors and presentations to FDA management personnel in regards to validation activities.

Coordinate the DQ IQ OQ PQ and PV of all validation activities to assure compliance with customer requirements ISO 9001 &CFR 210 & 211 21CFR 820 ICH Q7 and IPEC.

Identify any areas for improvement and propose / implement approved necessary changes.

Prepares writes and reviews validation protocols Master Validation Plan (MVP) and documentation to ensure compliance and adherence to AVANTORs SOPs Customer specifications ISO9001 ISOCFR820 and other applicable regulations. This includes regulatory bodies in the US and International.

Maintains all Validations and assures they are updated as required. Periodic review is established based on a data review of quality inputs and outputs to assure outcome is as expected.

Review need for validation with design group all processes equipment methods etc.

Responsible for performing validation and managing large size validation projects and supervising technicians / engineers providing necessary leadership and guidance.

Responsible for the generation of protocols using a risk based approach that meets current regulatory requirements and industry practices as well as performing design qualification.

Responsible for managing to validation metrics.

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 14000 associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.

The work we do changes peoples 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 moms 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!

Pay Transparency :

The expected pre-tax pay for this position is

$77300.00 - $128700.00

Actual pay may differ depending on relevant factors such as prior experience and geographic location.

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 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.

Avantor offers a comprehensive benefits package including medical dental and vision coverage wellness programs health savings and flexible spending accounts a 401(k) plan with company match and an employee stock purchase program. Employees also receive 11 paid holidays accrue 18 PTO days annually are eligible for volunteer time off and 6 weeks of 100% paid parental leave (except in states that offer paid family leave). These benefits may not apply to employees covered by a collective bargaining agreement or those subject to other eligibility rules.

Required Experience :

Senior IC

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

Monthly Salary Salary : 77300 - 128700