BeiGene 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.

General Description:

We are seeking an experienced and results-driven Senior Instrumentation Calibration Engineer/Manager to lead our calibration team in ensuring the reliability, accuracy, and compliance of all critical instrumentation systems. This leadership role is essential for maintaining pharmaceutical regulatory standards, supporting manufacturing and laboratory operations, and driving continuous improvement initiatives. The ideal candidate will combine deep technical expertise with strong leadership and project management skills.  This role will act as a point of contact with different business areas, lead and handle calibration reporting, ensure the calibration program meets corporate and regulatory expectations, lead contractors for execution of calibration work, develop risk assessments, support audits and inspections, write deviations, root causes, and corrective actions.

Works to ensure the efficient and effective day to day operations of the calibration team. Ensures the calibration function supports operational needs and ensures regulatory compliance requirements are met.

Essential Functions of the job:

• Develop and approve cGMP documents.
• Leading and Managing projects for the calibration of equipment to meet all safety, quality, regulatory and operational requirements.
• Review and approval of equipment specification/design/procurement/installation.
• Employee will be required to work closely with both manufacturing, quality, and engineering associates.
• Ensuring appropriate investigation of calibration discrepancies, errors, protocol failures, or testing errors requiring documented review and action to reconcile deviations.
• Position flows based on project/site needs.
• Develop and calibrate measurement instruments and systems.
• Perform routine maintenance and troubleshooting of measurement equipment.
• Analyze measurement data to ensure accuracy and consistency.
• Provide technical support and training to other departments.
• Document and report measurement and calibration results.
• Conduct research to improve measurement techniques and technologies.
• Collaborate with engineers and scientists to resolve measurement challenges.
• Certify equipment and processes according to national and international standards.
• Undertaking any other duties for any department within the business, which may be requested by the Line Manager, for which training and/or an explanation has been provided and understood.

Significant Contacts

• Site leaders, site engineering department, frequently interacts with all levels of BeiGene manufacturing employees.

Supervisory Responsibilities:

• Will manage contract, consultant staff.  Also responsible for a team of FTE’s at site, including CMMS team.   

Computer Skills:

• Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint); knowledge of SAP QM module

Qualifications:

• Bachelors degree (ideally: pharmaceutical sciences, engineering, physics, metrology, or related discipline).
• Minimum of 7 years’ experience (or 5 years with advanced degree) in calibration, facilities/engineering in an FDA-regulated biotechnology or pharmaceutical company with progressive levels of responsibility.
• Minimum of 5 years’ experience in management, with knowledge of cGMP and Data Integrity principles.
• Minimum of 5 years’ experience in metrology and CMMS management.
• Strong knowledge of cGMP’s.
• Knowledgeable in cGMP risk assessments and processes for following well documented and thought through risk-based approaches.
• Demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
• Credible and confident communicator (written and verbal) at all levels.
• Strategic thinker, highly customer focused. Strong analytical and problem-solving ability.
• Hands-on approach, with a ‘can do’ attitude. Able to work under minimal supervision.
• Ability to prioritize, demonstrating good time management skills.
• Familiarity with industry standards such as ISO/IEC 17025 and regulatory requirements.
• Proficient in using measurement software and tools.
• Detail-oriented with