Production Technician II 生产技术员 at Novartis

Haiyan, Zhejiang, China -

Full Time

Start Date

Immediate

Expiry Date

22 Jun, 26

Salary

0.0

Posted On

24 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Operating Isolators, Aseptic Techniques, cGMP Compliance, SOP Adherence, Environmental Monitoring, Batch Record Execution, Radiation Safety, Material Preparation, Sterilization, Gowning Qualifications, Validation Activities, MS Office

Industry

Pharmaceutical Manufacturing

Description

Band Level 2 Job Description Summary Production Technician plays an active role in daily production of Radioligand Therapies (RLT) as well as setup and preparation of instruments and equipment. The Production Technician adheres to regulatory requirements while performing job functions, executing production as per batch records and SOPs. Responsibilities are performed within a team and according to an assigned production shift schedule. The Production Technician works closely with the Manager and Lead to ensure production is executed in a safe and timely manner. Job Description Major accountabilities: Executes all activities related to the manufacturing of RLT products. Responsibilities include operating and maintaining grade A isolators, focusing on KPI goals as well as ensuring all state, federal and Novartis radiation safety guidelines are adhered to. Responsible for successful on time completion of required training curriculum comprising of the necessary Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications and other relevant training including HSE for the specific role. Supports all technical aspects related to production readiness including manually cleaning the cell and performing sterilization of the isolators using vaporized hydrogen peroxide. Conducts routine and dynamic environmental monitoring as required. Prepares all materials while maintaining material identity in accordance with the batch monitoring system as defined by procedure. Participation in assigned qualification/validation activities, as necessary. Facilitates a culture of “speaking up” and ensuring all cGMP compliance activities are followed. Prepares applicable documents and records such as batch records, shipping documents, and training materials. Given the time sensitive nature of the product, this position will require unplanned overtime to ensure process continuity and completion. Other duties may be assigned, as necessary. Key performance indicators: Right First Time Batch Record execution. No recurrent deviations. Adherence to Attendance Guidelines and all Safety related procedures No major or critical audit findings pertinent to the Grade A isolators or Grade B/C areas. Manufacturing compliance/adherent to all GDP/GMP principles Aseptic/CleanroombehaviorinaccordancewithGMPguidelines Minimum Requirements: Specific Professional Competencies： Flexibility to don clean room garments and personal protective equipment (PPE). Near vision performance should be the equivalent of 20/20 with no impairment of color vision. The use of corrective lenses to achieve the desired visual acuity is permitted. Makeup, jewelry, nail polish, perfume/cologne and other potential microbial sources are prohibited in restricted areas. Ability to lift or carry up to 35 pounds. Education: Bachelor of Science strongly preferred. If the applicant does not have a degree, a minimum of 2 years of experience in a cGMP or aseptic environment is required. Languages: Proficiency in Chinese; preferably to use English as working language Experience / Professional requirements: Internal candidates: Has been a Production Technician for a minimum of 12 months including prior RLT experience and are qualified in at least two critical production isolator tasks External candidates: 2-4 years of experience in aseptic pharmaceutical manufacturing. Preferably in drug product filling operations. Knowledge of cGMP regulations and FDA guidance applicable to aseptic manufacturing. Proficient in MS Office applications. Skills Desired General Hse Knowledge , gmp knowledge Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives. Novartis is aware of employment scams which make false use of our company name or leader’s names or recruiter’s names to defraud job seekers. Novartis does not make job offers without interview and never asks candidates for money. If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information. In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .

Responsibilities

The Production Technician executes all activities related to manufacturing Radioligand Therapies (RLT) products, including operating and maintaining Grade A isolators while strictly adhering to radiation safety guidelines. Responsibilities also involve supporting production readiness through cleaning and sterilization of isolators using vaporized hydrogen peroxide and preparing necessary documentation like batch records.