System Validation Engineer

Aequor; Princeton (NJ); Hybrid; USD 72,000 - 81,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a System Validation Engineer in Princeton, NJ. This hybrid role involves supporting project teams in QA processes and ensuring compliance with regulatory standards. Candidates should have significant experience in computer system validation and excellent technical skills. Join a dynamic team where your expertise will make a meaningful impact on critical validation projects over a 12-month contract.

Qualifications

• Minimum of 5 years in computer systems validation in the pharmaceutical industry.
• At least 2 years managing/overseeing computer system validation.
• Subject matter expert with knowledge of GAMP and regulatory guidelines.

Responsibilities

• Support the Computerized System project teams in review and QA approval.
• Implement and validate computerized systems, reviewing validation deliverables.
• Provide guidance in compliance with 21 CFR Part 11 and data integrity principles.

Skills

Computer system validation

GAMP

Electronic Records/Electronic Signature regulations

Data management

Planning and organization

Communication skills

Critical thinking

Attention to detail

Education

Bachelor’s degree in computer science, engineering, life science or related field

Tools

Microsoft Excel

Microsoft Word

Microsoft Outlook

Job description

1 week ago Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

This range is provided by Aequor. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$80.00/hr - $85.00/hr

Direct message the job poster from Aequor

Location: Princeton, NJ (Hybrid)

Duration: 12 Months

Job Description

• Responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with global regulatory guidelines.
• Provide input into developing scope, actions, and timelines on computer system validation projects and be accountable for implementing and validating computerized systems, including reviewing and approving validation deliverables and change controls.
• Contribute expertise and provide guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participate in assessments

Skills

• Candidate must be a subject matter expert in computer system validation, GAMP, Electronic Records/Electronic Signature regulations, and related health authority regulations and guidelines.
• Candidate must be technically conversant in concepts and techniques related to software development and data management.
• Demonstrated ability to plan and organize effectively across multiple projects and tasks.
• Demonstrated ability to influence, collaborate, and communicate directly at various organizational levels.
• Proficiency in Microsoft Excel, Word, and Outlook.
• Critical thinking skills in analyzing and exercising judgment on complex issues, guided by a thorough understanding of quality philosophy.
• Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up and judgment and ability to prioritize.
• Skilled at effectively communicating department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines.
• Able to gain the cooperation of others.

Education

• Bachelor’s degree or equivalent in computer science, engineering, life science or related field. A minimum of 5 years of experience in computer systems validation in the pharmaceutical industry, including at least 2 years managing/overseeing computer system validation

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

Referrals increase your chances of interviewing at Aequor by 2x

Sign in to set job alerts for “System Validation Engineer” roles.

Princeton, NJ $72,800.00-$80,100.00 1 week ago

Lead QA Engineer – Data & ETL or QA Lead – Snowflake/Matillion

Somerset, NJ $79,750.00-$111,600.00 1 month ago

Data Center Engineer, Mechanical, Data Center Technology Systems

New Jersey, United States $171,000.00-$254,000.00 2 days ago

New Jersey, United States $110,000.00-$115,000.00 4 weeks ago

Trenton, NJ $80,000.00-$105,000.00 6 days ago

Data Center Engineer - Elite FinTech - $80,000-$150,000 + Bonus

New Jersey, United States $80,000.00-$160,000.00 3 days ago

Piscataway, NJ $107,000.00-$150,000.00 1 day ago

Sr. Quality Assurance Engineer (IAC24122)

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.