Computer System Validation Consultant -Analytical Instruments

Job Description

The Agilent CrossLab Group is looking for a Computer System Validation Engineer to deliver compliance consulting services to our customers in the FDA regulated markets (i.e. Pharmaceutical, Biotech, BioPharma, Nutraceuticals, etc.). We are looking for an individual with a solid background in regulatory compliance as it relates to laboratory environments, Chromatography software, instrumentation systems. Experience in scientifically sound laboratory practices and quality assurance is desirable. Success in this role is ultimately measured by delivering the highest quality compliance consulting services to our customers while meeting pre-determined timelines. You will deliver and manage compliance consulting projects focused on, Computerized System Validation (CSV), Based on the GAMP® 5 methodology and Data Integrity assessment/remediation. You will need to stay current with related industry trends and regulations to be able to deliver best in class service. Working with the Informatics Software Application Engineer, Service and Support, and Enterprise service teams this role will provide customer specific compliance services to meet the customer's requirements.

Primary Areas of Consulting

• GAMP® 5 approach to computerized systems validation is critical to success in this role.
• Computerized System Validation
• Analytical Instrument Qualification, Audits/Assessments, custom procedure development, and Data Integrity assessments and remediation.
• Working knowledge of US FDA 21 CFR Part 210/211, 21 CFR Part 11, and Eudralex Annex 11

Responsibilities

• Provide Computerized System Validation document authoring and execution services.

• Provide Data Integrity assessment and remediation.
• Manage compliance consulting projects
• Manage compliance vendors used for project delivery
• Work with sales team to develop SOW / pricing for customer opportunities
• Provide project management updates to customer and internal teams.
• Ensure customer requirements are met, and customer satisfaction obtained.
• Possess strong technical writing skills
• Provide SOP writing services (desirable)
• Communicate across diverse customer organizations (Scientific, IT, QA, Engineering, etc)
• Stay current with applicable regulatory trends and regulations
• Support business development activities
• Create annual personal goals and development plan with administrative manager

Must consent to participate and meet Agilent approved customer/vendor credentialing requirements necessary to gain access to customer sites. Requirements may include, but are not limited to, proof of identification, proof of certification to perform the work required, customer health and safety requirements, etc

Qualifications

• B.S./B.A. in Engineering, Science, Information Technology, or related field.
• 4+ of relevant work experience may be substituted in lieu of education in the specific fields listed above.
• 4+ years' experience in the field of Computer System Validation.
• 4+ years' experience in related Pharmaceutical or Healthcare Industries.
• Experience in the validation of at least two of the following computer system categories: clinical data/study management, automation control, laboratory systems, quality management systems, ERP, medical device software.  
• Must be able to quickly learn new software applications used in GxP activities.

Desired Qualifications

• Possess effective written and oral communication skills; ability to write, type, express or exchange ideas of a technical nature by means of the spoken word; convey information/instructions accurately; receive detailed information through oral or written forms and to translate those instructions into physical execution of tasks.
• Working knowledge of Microsoft Word and Microsoft Excel.  Other programs as may be required by the position, e.g., PowerPoint, Access, Microsoft Project, Visio.
• Must be able to work with client systems and equipment; analyze data for development of reports; sit and type for long periods of time; assemble documentation as required. 
• Basic knowledge of FDA GxPs, FDA Guidelines, and European Guidelines and other regulatory requirements.
• Basic knowledge of industry best practice such as GAMP5, ANSI standards (S-95, S-88), and ASTM (E2500).
• Basic knowledge of 21 CFR 11, including ERES, predicate rule and legacy system requirements.
• May be responsible for multiple accounts.
• This role will provide both remote and on-site (at customer facilities) support depending on the customer and project requirements and the nature of the specific work being performed. Estimated travel is less than 25%. Currently, all work is remote.

Additional Details

This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least March 19, 2026 or until the job is no longer posted. In the US, this position is eligible for reimbursement for personal vehicle usage.The full-time equivalent pay range for this position is $93,760.00 - $146,500.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locationsAgilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_posting@agilent.com or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.

Travel Required:

10% of the Time

Shift:

Day

Duration:

No End Date

Job Function:

Services & Support