Inspection_Operation_Engineer

The position holder is expected to take more independent decision gradually within the area of responsibility and based on assignment requirements.
Level of independence, innovation and initiative:
Trouble shooting and process performance improvement after PV
Support and maintain theinspectionprocess in production
Capable of operatingand cleaningthe equipment
Loyal to the company
Living up to relevant laws, regulations and commitments.
Accountable.
Ambitious.
Responsible.
Ready for change.
Open and honest.
Having the courage to bring forward own opinions also when disagree.
•As a team member to complete PQ/PV, OEE improvement and production related documents
•A back up to otherengineersortechnicians in the wholபைடு நூலகம்inspectionarea
Prefer automatic inspection experience.
Prefer pharmaceutical CNC area experience
cGMP manufacturing process validation experience is plus
Job content (purpose of the job)
•Keepinginspectionprocess in compliance with regulation and business requirements
Main job tasks:
Participate inproductionactivities and training in order to ensure needed competences for taking the role as end user.E.g.filling up the BPR and logbook; PRISM, SAP, NNTZW, point light system routine job.
Intercultural understanding and ability to work effectively with other nationalities
Tolerance of differences and personal characteristics
Proactive to build network and effective relations
Easy going and open minded with people.
Ensure that solutions fitsSFDA regulation andlocal conditions
Thinking and Acting Globally
Has good awareness of own strengths, limitations and development needs and applies this to optimize performance and relationships
As a team member to establish allinspectionprocesses.The overall success will be measured upon
1.Performance in productionincluding operation
2.Capability of process support independently
Number of subordinates with direct/indirect referral:
This position has no subordinatesin the project phase and production phase.
Qualifications (minimum requirements):
Reviews of technical solutions and process designs, e.g. BCO, 5s fulfillment in place.
Technical solutions on issues in implementation ofInspectionprocesses. E.g. NC/CR case handling.
Education:
BachelorDegreein microbiology, mechanical engineering, manufacturing engineering, chemistry, pharmacist,or bioscience.Masterdegree is plus.
cGMP training
Stipulated % of total
Key areas of responsibility:
This engineerfor theinspectionareawill be responsible for project support and production execution.
The position will be based inTianjin.
Within your area you areaccountablefor ensuring theexecutionof the projectand theproductionramp-up strategy:
•Participation ofvalidationand process development. After these activities, you will be given more responsibilities.
Excellent command of written and spoken English.
Professional experience:
Proven3–5years production experience in aseptic process of cGMP regulated pharmaceutical industry or in life science industry
Creatively analyzetechnicalproblems/issues in order to reach innovative, cost-effective and timely decisions
Main stakeholders / reputation and results:
Establishment,revision, archivesof SOPs (Standard Operation Procedure)andother required documents.
Training of employeeson process and operation, e.g. operators and technicians
The buildup of knowledge during project andtransference to the future plant organization is crucial to a successful fast ramp up into a high performance plant.
Communication / Interaction with other internally or externally:
The tasks are complex and require corporation across an international organisation. The position requires:
Process support team, production team, quality group are the main stakeholders.
Must be able to network, collaborate and work at a high professional level with Project Teams and key stakeholders in FP-Tianjin and DFP; and maintain a reputation for fulfilling expectations and delivering results.
As a concept the plant will beharmonized companybest practices applied at other sites in NN. The position holder will therefore:
Proactively seek best practices and duplicate within area of responsibility
NOVO NORDISK
JOB DESCRIPTION
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