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The Position

Engineering Project Support and Operation Readiness:

Act as the Calibration Engineer representative on the project team, contributing to design, construction, and qualification activities. This includes reviewing URS (User Requirement Specification) and executing FAT and SAT to contribute to project delivery.
Lead or act as calibration team coordinate with Engineering department, production department, quality department, vendors, etc. for cooperation to achieve the positive goal.
Establish and develop the calibration/monitoring system in alignment with the Roche standards including maintenance management system, people training and qualification, CCS strategy and implementation to support robust operation readiness.
Support manager to develop a competent team through coaching, mentoring and training by having in place a skill competencies development and appraisal program to strengthen the technical expertise and capabilities.
Participate in tech transfer, collaboration with other functions to ensure the success of new product manufacturing.
Represents the calibration during regulatory inspections and audits and participates in the response of regulator audit and global quality audit.

Routine Operation & Maintenance:

System Ownership:
Work as a Sterilization aseptic expert to provide technical support in calibration aspects.
Well plan and schedule calibration to maximize equipment availability.
Calibration Execution: Implement calibration for measuring instruments within assigned categories in time according to calibration plan. Manage Third Party to ensure that all the measuring/reference instruments within assigned categories are calculated in time according to calibration plan.
Maintain Calibration and monitoring SOP/National Standard: Maintain calibration and monitoring SOPs to ensure that calibration and monitoring activities compliance with relevant company policies, headquarter guidelines and regulatory guidelines. Follow up the National Standards updating and ensure that the calibration work of the company meets the requirement of the regulations.
Responsible for Calibration Assessment, perform criticality assessment for the instruments.
Monitoring and Test: Plan and implement environment monitoring and test (Airborne Particle Count, Smoke Test/Airflow Visualization Test, Airflow Direction Test, Air Change Rate Test, Recovery Test, HEPA/ULPA Filter Integrity Test, Compressed Air Test, Illuminance, etc.) for GMP area in order to ensure that the production running is carried out in the appropriate environment as GMP required.
Ensure that all relevant information relating to activities within your scope are tracked, captured and forwarded in due time to your manager or the head of department
Drive continuous improvement initiatives to enhance sustainability, safety, and asset reliability.
Establish and maintain a strategic and technical roadmap for the responsible area to support the site's strategic development and product lifecycle.
Compliance:
Ensure audit readiness by adhering to cGMP, regulatory, and statutory requirements to protect product quality and prevent compliance observations.
Represent the calibration during regulatory inspections and audits.
Responsible for the Quality and Accuracy of data and records of relevant equipment and maintenance.
Maintain accurate and timely records of all equipment and maintenance data. Draft and/or review SOPs and other relevant documentation.

Qualifications

Bachelor of Engineering Degree or above: Measurement and Control Technology, Instrumentation and Control Engineering, Instrumentation Engineering or equivalent.
Familiarity with relevant local regulations and authorities (e.g., NMPA).
Familiar with laws, regulations, ISO standards, and industry standards related to metrology and calibration.
Calibration related certification is a plus.

Job Required Competencies

Experience: Minimum of 8 years of calibration management or engineering experience in injection pharmaceutical industry, MNC Bio-pharma preferred.
Expertise:
Metrology and Calibration Techniques: Measurement Principles and Uncertainty Analysis, Calibration Methods, Calibration Equipment.
Regulations and Standards: Familiarity with national laws, regulations, and industry standards related to metrology and calibration, including national accreditation bodies like CNAS and international organizations such as BIPM and OIML.
Project Expertise: Proven experience in strategic projects for Aseptic Filling facilities, including design, commissioning, and qualification.
Startup Experience: Experienced in new facility startup readiness and operation ramp-up.
Communication: Fluent in written and spoken English, with strong collaboration skills to effectively work with diverse teams and stakeholders.
Strategy Thinking: Able to think strategically and translate strategies into actionable plans, understand and apply agile ways of working

Preferred Qualifications (Nice to Have)

Experience with Lean Manufacturing or Six Sigma methodologies.
PMP or other project management certifications.

Who We Are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

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