Summer Internship: QA Validation Intern - Hopewell

BeiGene • Hopewell, NJ

21h • $27 • Onsite

About The Position

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. Internship program dates: June 8 - August 21, 2026 Education Required: Bachelor of Science Degree In Progress in a related scientific discipline General Description: This position is based in Hopewell, NJ. Supports QA Validation activities, ensuring the successful day to day operations by supporting validation documentation reviews, investigations, area walkthroughs, project activities and related Quality support activities. Works to support QA Key Performance Indicators (KPIs) such as Validation review/approval completion per schedule, SOP mandated cycle times, and QA objectives, whilst adhering to regulatory compliance and achieving business success. Creates and/or reviews SOPs need to support the business. Essential Functions of the job: Gain working knowledge of QA support of Capital Projects Ensure all activities are performed in accordance with GMPs, SOPs and Health and Safety policies. Observes qualification activities in drug substance, drug product, and quality control areas. Redline procedures and GMP documentation for future revision and process improvement initiatives Reviews GMP documentation (SAT, IQ, OQ, PQ, spec documents) for compliance with site procedures. Supports Quality Assurance activities to ensure compliance with FDA/EU regulations. Supports the writing and/or revising of SOPs, ensuring regulatory compliance in conjunction with being ‘fit for purpose’ operationally and commercially. Awareness of USP/EP, ICH Guidelines, QC methodology updates to ensure compliance with current testing and specifications. Ensuring appropriate investigation of validation discrepancies, errors, protocol failures, or validation testing errors requiring documented review and corrective action. Ensuring that the Quality department meets or improves key performance indicators (KPIs). Undertaking any other duties for any department within the business, which may be requested by Management, for which training and/or an explanation has been provided and understood.

Requirements

• Scientific degree in progress (ideally: pharmaceutical sciences, engineering, chemistry, or related discipline)
• Working knowledge of cGMPs: 21CFR parts 2010 & 211, knowledge of 21CFR600 – Biologics desirable.
• Preferred experience working with an ERP system, such as SAP, and eQMS systems such as TrackWise or Veeva.
• Ability to collaborate with project teams
• Credible and confident communicator (written and verbal).
• Customer focused, Strong analytical and problem-solving ability.
• Hands-on approach, with a ‘can do’ attitude.
• Ability to prioritize, demonstrating good time management skills.
• Good attention to detail, with the ability to work accurately in a busy and demanding environment.
• Self-motivated, with the ability to work proactively using own initiative.
• Committed to learning and development.
• Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).
• Must be able to work in the US without corporate sponsorship.

Nice To Haves

• Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook)
• Understanding of AI Tools

Responsibilities

• Gain working knowledge of QA support of Capital Projects
• Ensure all activities are performed in accordance with GMPs, SOPs and Health and Safety policies.
• Observes qualification activities in drug substance, drug product, and quality control areas.
• Redline procedures and GMP documentation for future revision and process improvement initiatives
• Reviews GMP documentation (SAT, IQ, OQ, PQ, spec documents) for compliance with site procedures.
• Supports Quality Assurance activities to ensure compliance with FDA/EU regulations.
• Supports the writing and/or revising of SOPs, ensuring regulatory compliance in conjunction with being ‘fit for purpose’ operationally and commercially.
• Awareness of USP/EP, ICH Guidelines, QC methodology updates to ensure compliance with current testing and specifications.
• Ensuring appropriate investigation of validation discrepancies, errors, protocol failures, or validation testing errors requiring documented review and corrective action.
• Ensuring that the Quality department meets or improves key performance indicators (KPIs).
• Undertaking any other duties for any department within the business, which may be requested by Management, for which training and/or an explanation has been provided and understood.

Benefits

• All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan.
• The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

What This Job Offers

• Career Level: Intern