Validation Engineer II

1 day ago


Hopewell, New Jersey, United States BeiGene Full time
Job Summary

We are seeking a highly skilled Validation Engineer II to join our team at BeiGene. As a key member of our Validation function, you will be responsible for ensuring the successful management of related activities and large projects, while supporting Validation objectives and adhering to regulatory compliance and achieving commercial success.

Key Responsibilities
  • Develop and approve cGMP documents, including equipment and instrument qualification, commissioning, master validation plans, SOPs, comparability reports, aseptic process simulation protocols, and reports.
  • Lead validation activities for project activities, including review of validation documentation and attendance at validation activities (FAT, SAT, IQ, OQ, PQ).
  • Ensure the Validation department meets or improves key performance indicators (KPIs) and works to ensure all validation projects are on time and on budget.
  • Manage validation consultants on a large project basis, as needed.
  • Review equipment specification/design/procurement/installation and validation.
  • Project planning and execution, including scheduling, task management, milestone planning, and reporting.
  • Generation, review, and approval of project documentation (User Requirement Specifications, validation protocols, reports) and Standard Operating Procedures.
  • Maintain the validation sample management, assess the requirements for data acquisition, and coordinate validation projects.
  • Ensure appropriate investigation of validation discrepancies, errors, protocol failures, or validation testing errors requiring documented review and action to reconcile deviations.
Requirements
  • Bachelor of Science Degree in a related scientific discipline or equivalent work experience.
  • Strong knowledge of cGMPs.
  • Knowledgeable in risk assessments and process for following well-documented and thought-through risk-based approaches.
  • Biotech and/or Sterile manufacturing and aseptic processing knowledge required.
  • Knowledgeable in Computerized System Validation (CSV).
  • Minimum of 4 years' experience in validation (with degree) or 7 years (without a degree), biological quality assurance and/or quality control in an FDA-regulated biotechnology or pharmaceutical company with progressive levels of responsibility.
  • Knowledge of cGMPs and Data Integrity principles.
  • Demonstrable track record and skills/experience gained within a similar position(s), at a similar level. Good personal leadership.
  • Good communicator (written and verbal) at all levels.
  • Customer-focused. Strong analytical and problem-solving ability.
  • Hands-on approach, with a 'can-do' attitude. Able to work under minimal or appropriate supervision level.
  • Ability to prioritize, demonstrating good time management skills.
  • Excellent 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.
Preferred Qualifications
  • Good IT skills, e.g., Microsoft Office (Word, Excel, PowerPoint, Project, and Outlook); working knowledge of SAP desirable but not required.
Travel Requirements

Must be willing to travel approximately 10%; requires a valid passport.



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