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Validation Specialist / Provantage Lab_Life Science (Yokohama)

A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 

[English Follows]

 

職種:バリデーション試験受託

業種:ライフサイエンス、バイオテクノロジー

勤務地:横浜

勤務シフト:定時9:0017:307時間30分)、これに準じ、7:0015:30から13:0021:30のシフト勤務有

フレックス制ではございません。

 

職務内容:

製薬会社が製造工程で使用するろ過滅菌用フィルターのバリデーション試験を受託しているラボでの実験業務をご担当いただきます。

当ラボはISO9001基準に基づいた高い品質、及び最新のガイドラインに適合した世界共通の試験サービスを提供しています。

・実験及びデータ、文書作成業務(細菌捕捉バリデーション、適合性試験、医薬品を用いたフィルターの完全性試験等)及び文書の翻訳業務

・業務の品質維持、向上のための活動

・世界にある5箇所のバリデーションラボとの協働。グローバルプロジェクトへの参加

・顧客へ最新の業界情報の提供(技術セミナー、ソートリーダーシップ活動等)

 

必須条件:

・ライフサイエンス分野や製薬会社でQuality Control、研究、実験、エンジニアリング等の経験。

(または医療機器会社で技術営業を経験し、学生時に無菌操作の実験研究をした経歴の方も対象)

・クリーンベンチ(可能であればクリーンルーム)における無菌操作の技術と業務経験。

TOEIC 600点以上、ビジネスレベルの英語力(会話、読み、書き)と日本語力、英語の科学論文がある程度読解できる。(データ入力システムは英語ベースです)

(現状読み書きレベルの英語力で、今後英会話力を伸ばしていきたいと考えている方も可)

・理学、生物学、化学、物理学、薬学、農学等の分野の学位または修士卒。

・コミュニケーション力があり、国内外の同僚との協働やディスカッション、顧客との技術的な会話が可能な方。

・抗がん剤、毒劇物等の取り扱い可能な方。

・実験作業に合わせた早番、遅番が可能な方。

 

歓迎条件:

・品質基準(GMPGLPISO等)に基づいた業務経験。

・培養プロセス、製薬プロセス、バリデーション、薬局方等のガイドライン、毒劇物の取り扱い、ろ過滅菌の知識。

・将来のラボのリーダーとして周囲を牽引していく情熱がある方。

・専門性の高い職場であるため、入社後の技術的、専門的知識の習得に加え、様々な場面で自ら判断し、物事を先に進める力が必要です。

・柔軟なアイディアを持ち、新しい技術の推進や業務効率化をリードできる方。

・ワークロードの優先付けができ、顧客、品質、結果を重視する。

・デジタルツールに慣れている。

・機器のIQ/OQの計画及び実施経験がある。

 

 

Industry type: Life-science, Biotechnology

Work at: Yokohama, Kanagawa Pref.

Work shift: Standard time: 9:00 am - 5:30 pm (7.5 hours), following this rule, there are several shifts from 7:00 am - 3:30 pm to 1:00 pm - 9:30 pm

Occupation category: Conduct validation experiment by customer’s demand

 

Job detail:

You will be responsible for conducting the validation tests for filter for sterilization at the laboratory that conducts the tests instead of the pharmaceutical company who uses filters at their production process. We provide common test services all over the world, they are high quality based on ISO9001 and adapted to latest guidelines.

-    Conduct experiments, make data, documents (Bacterial retention validation, Filter compatibility test, Integrity testing with product) and translation.

-    Activities for service quality maintenance and improvement

-    Collaborate with 5 Validation labs around the world. Participate in the global projects.

-    Provide the latest industry topics to customer (technical seminar, thought leadership activities)

 

Qualifications:

Education: Science, Biology, Chemistry, Physic, Pharmacy or Agricultural science etc. field’s Bachelor or Master’s degree

Work experienceMinimum 3 years in life-science business field

Required:

  • Have a technique and an experience for aseptic operation at the laminar flow food (if possible; clean room) at work
  • TOEIC score: more than 600, English (conversation, reading and writing) skill and Japanese skill for business, can read and understand outline of English scientific paper. (English based system for filling data is used)
  • Have a communication skill, collaborate / discuss with both domestic and foreign colleagues, have technical conversations with customers
  • Have capability to treat anti-cancer drugs, poisonous or toxic substances
  • Adjust early shift / late shift according to experiment time

 

Preferred:

  • Have some work experiences based on quality standard(s) (GMP, GLP and/or ISO etc.)
  • Have knowledges for microbial culturing process, pharmaceutical process, validation, industry guideline E.g. pharmacopeia, poisonous or toxic substances handling and filtration for sterilization
  • Have a passion for leading members as a future leader of Validation lab
  • Because we are working at a highly specialized workplace, you need to learn technical expertise after join, moreover you need to have forces to make decision by yourself and to promote something at the many situations.
  • Have flexible idea, can lead for introducing new technique and/or improving work efficiency
  • Can prioritize own workload. Customer, quality and result oriented
  • Familiar with digital tools
  • Have experiences for planning and conducting machine IQ/OQ

 

Recruting Contact: Nozomu Yokota

 

What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

 

Curious? Apply and find more information at https://jobs.vibrantm.com

Job Requisition ID:  218128
Location:  Yokohama
Career Level:  C - Professional (1-3 years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options. 

US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by the Company. The Company uses the definition of “fully vaccinated” assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request.  You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

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