Computer system validation engineer

Reference #: R-168273

The Opportunity: Avantor is seeking an experienced Computer System Validation Engineer to join our organization supporting validation activities for our GMP facilities.

This is a full-time, remote position.

What we're looking for

Education: BS/BA Degree in Computer Science, IT, Engineering, Science, or Business

Experience: 3 - 5 years of experience within a dedicated CSV or product software validation role. Proficient in system and software validation engineering processes, software risk management, software V&V methodologies, and software configuration management.

Proficient SAP Validation Experience required

Experience in FDA regulated environment with strong knowledge of regulatory compliance pertaining to software validation in IT Infrastructure and Enterprise Systems supporting business, manufacturing, or quality management (e.g., SAP, EtQ, LIMS, MES (Tulip) plus in-house developed software applications preferred.

Background in pharmaceutical or medical device industry strongly preferred.

Experience implementing large systems such as EtQ, LIMS, electronic batch record and/or SAP.

Strong process knowledge of SAP and its use in a regulated industry.

Demonstrated understanding of FDA Quality System Regulation and ISO/EU standards pertaining to computer software validation (e.g. 21CFR Part 820, Subpart G Production and Process Control, 820.70(i)) software validation/automated processes; 21 CFR Part 11 Electronic Records & Signatures; ISO 13485, 7.5.2 Validation of processes for production and service provision, section 7.5.2.1 General requirements, Eudralex vol 4. Annex 11).

Proven ability of working in a cross functional team environment with excellent leadership, interpersonal and communication skills. Proficient in presenting data to management.

Ability to influence others through persuasive, logical, and constructive debate based on data.

Excellent analytical, prioritization, and multi-tasking skills.

Knowledge and experience utilizing Microsoft Outlook, Word, Excel, and Access, or equivalent software packages.

Knowledge and experience utilizing a laboratory information management system (LIMS) and an Enterprise Resource Planning (ERP) system is preferred.

Knowledge and experience utilizing a digital batch record / manufacturing execution system such as Tulip is preferred.

How you will thrive and create an impact

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

Act as lead SME for CSV projects; including inquiries pertaining to the interpretation of FDA, EU, and other regulatory requirements for computer system validation.

Provides management with updates on projects, the health of the CSV process, and communicates risk-based issue escalations.

Provide technical decision-making regarding validation strategies and requirements for projects.

Strong understanding of IT network infrastructure and required qualification activities.

Remain current with US and international regulations, industry standards, and emerging topics (e.g., cybersecurity) pertaining to computer software validation.

Provides compliant and pragmatic leadership to software validation projects throughout the computer system's software development lifecycle including system retirement.

Provides valuable guidance during the design, deployment, maintenance, and retirement of IT computer system. This guidance applies to all systems developed in house, developed by contractors, and off the shelf (OTS) software. May perform supplemental research to provide options for compliant solutions to barriers encountered during validation activities.

Reviews and approves software validation documentation to ensure documentation is compliant with IT procedures and all applicable quality system regulations or standards.

Organizes or conducts training on software validation principles and Part 11 requirements.

Exercises judgment in selecting methods and language to provide compliant solutions to address and document issues, which may arise during validation activities.

Prepare, review, and approve various computer validation documents for CSV projects including the following:

Regulatory Assessment for determination of GxP and Part 11 relevance

Validation Plan

Technical Documentation (e.g., User Requirement, Functional Requirements, Design Specifications)

Requirements of Trace Matrix

Risk Assessment

IQ/OQ/PQ Protocols and Reports

Validation Summary Report

Recommends and/or drives continuous improvement activities to streamline validation processes. Leads or supports CSV remediation activities.

Serves as the CSV SME for internal and external audits.

Ensures that the system's validation state is maintained through proper testing as part of the change control program and re-validation as necessary. Performs a periodic review of systems to monitor the validation status of the system

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 [email protected] 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 .

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