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Job Title: Validation Engineer - Cloud Qualification Job Function: Validation Analyst Location: Bridgewater, NJ

About USDM

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM's clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Nature and Scope of Job

USDM is seeking an experienced Validation Consultant to join our team. The Validation Consultant will lead the qualification and validation of our client's critical cloud infrastructure, including AWS, Netwrix, and Druva. The role involves ensuring that these systems meet regulatory compliance requirements and are qualified for use in a GxP (Good Practice) environment. The ideal candidate will have extensive experience in validation processes, particularly in the life sciences industry, and a strong understanding of cloud-based systems, data security, and IT compliance.

Primary Responsibilities

Lead and execute the validation and qualification of AWS, Netwrix, Druva, and other cloud infrastructure components.
Develop and implement validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Ensure that the infrastructure components are compliant with relevant regulations (e.g., FDA 21 CFR Part 11, GxP, GDPR).
Create, review, and approve validation documentation, including validation plans, test scripts, validation summary reports, and traceability matrices.
Maintain accurate and detailed records of all validation activities, ensuring they meet regulatory and internal quality standards.
Work closely with quality assurance and IT teams to ensure alignment with company policies and procedures.
Conduct risk assessments to identify potential issues with infrastructure systems and propose mitigation strategies.
Ensure that any changes to the infrastructure are managed through a robust change control process, including re-validation when necessary.
Collaborate with cross-functional teams, including IT, Quality Assurance, and Regulatory Affairs, to ensure that all validation activities are completed on time and within budget.
Provide guidance and training to internal teams on validation processes and best practices.
Communicate progress, challenges, and risks to senior management and other stakeholders.
Identify opportunities for improving validation processes and contribute to the development of validation best practices.
Stay up-to-date with industry trends and changes in regulatory requirements to ensure continuous compliance.

Additional Responsibilities

Other duties as assigned.

Qualifications

Minimum of 5 years of experience in IT infrastructure validation within a regulated industry, preferably biotech, pharmaceutical, or medical device.
Strong knowledge of cloud infrastructure (AWS preferred) and related compliance requirements.
Experience with validation of data security tools (Netwrix) and data protection/backup solutions (Druva).
Familiarity with FDA regulations, GxP guidelines, and international data privacy regulations.
Excellent written and verbal communication skills, with the ability to produce high-quality documentation.
Strong problem-solving skills and attention to detail.
Certifications in AWS, Netwrix, or Druva. (preferred)
Experience with project management in a validation or compliance context. (preferred)
Previous experience working in a biotech or pharmaceutical company. (preferred)

Education & Certification Requirements

Bachelor's degree in Computer Science, Information Technology, Life Sciences, or a related field.

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job, and are not meant to be all inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
Operate other office productivity machinery, such as a calculator, scanner, or printer.
Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.

Equal Opportunity Statement

USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Compensation

Salary/Hourly Rate Range (W2): USD 55.00 - 75.00

The base salary/hourly rate range represents the anticipated low and high end of the USDM's compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate's qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.

Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.

Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off.

All employees are eligible for USDM's rewards and recognition program.

For more details about our benefits, visit us here: https://usdm.com/careers