Computer Systems Validation (CSV) & Compliance Associate

About the role

Launch your career with a global pharmaceutical leader in Collegeville, PA! This is a 6‑month hybrid contract (onsite 1x/week or bi‑weekly) supporting quality teams from an administrative angle. Ideal for an early‑career candidate looking to apply software development lifecycle knowledge within a regulated life sciences environment.

Responsibilities

• Assist in managing the end‑to‑end SDLC documentation lifecycle for engineering teams, ensuring artifact review, approval, and audit readiness.
• Liaise with technical contributors and quality stakeholders to coordinate document routing and secure approvals.
• Perform technical writing reviews on draft engineering documentation to identify issues and ensure compliance.
• Maintain document repositories, version control practices, and traceability for regulatory inspections.
• Track outstanding quality records and support internal risk and issue management policies.

Qualifications

• Bachelor's degree in a Scientific Discipline.
• 1‑4 years of relevant professional experience.
• Basic experience or exposure to the Software Development Lifecycle (SDLC).
• Familiarity with Computer Systems Validation (CSV) or Governance, Risk, and Compliance (GRC) concepts in developed software systems.
• Fundamental understanding of information security and cloud security principles.
• Strong technical writing, organizational, and document administrative capabilities.

Skills

• Biology
• Chemistry
• Quality Assurance (QA)
• Quality Control (QC)

Pay

$44.00 – $45.93 per hour

Benefits

• Medical, prescription, dental, vision, AD&D, and life insurance
• Short‑term disability
• 401K plan (eligibility‑based)