Data Integrity Engineer (Contract - Remote)

ProPharma; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

A leading consulting firm is seeking a Computer Systems Validation Engineer II responsible for performing validation projects for clients. This role is primarily remote, requiring some onsite visits, and demands strong leadership and communication skills. Candidates must have at least 5 years of experience in Computer System Validation and the Pharmaceutical, Medical Device, Clinical Research, or Healthcare Industries.

Qualifications

• 5+ years of experience in Computer System Validation.
• 5+ years in Pharmaceutical, Medical Device, Clinical Research, or Healthcare Industries.

Responsibilities

• Participate in delivery of CSV projects.
• Lead documentation of user requirements.
• Author functional requirements specifications.
• Perform validation testing protocols and document results.
• Prepare project status reports.

Skills

Leadership skills

Communication skills

Software testing techniques

Team collaboration

Education

AS or B.S./B.A. in Software Engineering, Computer Science, Information Technology

Job description

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

The Computer Systems Validation Engineer II position is responsible for performing Computer System Validation (CSV) projects for clients under the guidance of more experienced CSV professionals. Candidate must have strong leadership and communication skills.

This is a contract role, 40 hrs/week through Q1 2026. Primarily remote with some onsite visits.

Essential Functions

• Participate on teams of internal resources in delivery of CSV projects.
• Lead clients in documentation of user requirements
• Author functional requirements specifications that are complete, accurate, and testable
• Author system Risk Assessments, 21 CFR 11 Assessments, and Annex 11 Assessment
• Author Validation Plans and Validation Reports
• Author validation and verification testing protocols/scripts (i.e., IQ, OQ, PQ) and Trace Matrices
• Execute validation and verification testing protocols and document test results
• Author SOPs for User Operation, System Administration and Maintenance, Back-up/Recovery, and Audit Trail Review
• Prepare project status reports for clients and ProPharma management
• Extensive travel may be required at times.
• Other duties as assigned.

Necessary Skills and Abilities

• Exposure to at least two of these computer system categories: automation control, laboratory systems, quality management systems, ERPs, clinical trial and pharmacovigilance applications.
• Working knowledge of software testing techniques and test case development best practices.
• Awareness of industry best practices such as GAMP5, ANSI standards (S-95, S-88), and ASTM (E2500).
• Able to work effectively with local and virtual team members and other professionals, such as QA specialists, software developers, and system users
• Effective written and oral communication skills; ability to write, type, express or exchange ideas of atechnical nature by means of the spoken word; convey information/instructions accurately; receivedetailed information through oral or written forms and to translate those instructions into physical execution of tasks.

Educational Requirements

• AS or B.S./B.A. in Software Engineering, Computer Science, Information Technology, or a related field.

Experience Requirements

• Minimum 5 years of experience in the field of Computer System Validation.
• Minimum 5 years of experience in Pharmaceutical, Medical Device, Clinical Research, or Healthcare Industries.

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We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

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