バリデーションエンジニア(医薬品向け自動機械担当)/ Validation Engineer

Syntegon Technology K.K. • Namegawa

  • Full-time

Namegawa

from today

シンテゴンテクノロジーは、医薬品・食品の製造プロセス・包装機械のリーディングサプライヤーです。

ボッシュの包装機械事業部であったボッシュパッケージングテクノロジーとして、50年に渡り医薬品および食品分野における技術を中心に事業を展開し、2020年1月からは、ヴァイブリンゲン(ドイツ)に本社をもつ企業、シンテゴンテクノロジーとして独立しました。

シンテゴンテクノロジーは、世界15か国以上で30を超える拠点を構え、医薬品向け検査技術においては、“Center of Competence” として当社日本法人がワールドワイドの開発をリードしています。

Your duties

医薬品製造における各種包装機・検査機の世界シェア最大級のメーカーである当社にて、医薬品の洗浄、滅菌、充填機などの自動機械、主に注射剤の充填ラインに納品した自社製品の検査(バリデーション)業務を担当いただきます。

バリデーションにおいては、GMPと呼ばれる薬の安全を守る為の規則に機械が適合しているかどうかを確認します。主な業務としては下記の通りです。
①据付時適格性検査と呼ばれる据え付けられた機械が設計仕様に合致しているかの確認。(重要部品の確認、配管勾配の確認等々)
②キャリブレーション、対象となる温度センサー等の計装機器が適合基準内かどうかを確認します。
③運転時適格性検査 ①②で確認した機械を実際に運転しGMPの規則に合致しているものかどうかの確認。(*主な検査、洗浄機:洗浄機能確認 トンネル滅菌機:風速、HEPA*フィルターリーク、清浄度、温度分布確認、充填機:充填精度確認 。
*各検査にはそれぞれに必要な測定器(国家標準にトレーサブルな校正済のもの)を使用します。
*①、②、③の検査をする為の書類を作成し、作成した書類に従い検査を実施します。

Your profile

・高専もしくは大卒以上:機械工学系(電気・機械、数学・物理の基礎的知識)
・メーカー系企業におけるフィールドエンジニアリング職経験:3年以上
・国内での出張業務が可能な方
・機動力、チームワーク、コミュニケーション能力の高い方
・TOEICスコア 500 以上(英語メールや文章の読解に苦手意識がないかた)

歓迎する要件

・測定器の知識
・機械制御知識:プログラミング、PLC、PC、OS、LAN     
・GMP(医薬品適正製造基準)の知識
・電気工事士の資格

More information

【勤務地】
コンピテンスセンタージャパン アンド ビジョンテクノロジー事業所
埼玉県比企郡滑川町月輪1464-4(最寄駅:東武東上線「つきのわ駅」より徒歩10分)

【勤務時間】
8:4517:30(休憩12:1513:00)所定労働時間8時間
フレックスタイム制度、在宅勤務制度あり

【給与】
経験・能力を考慮のうえ処遇いたします。

【休日休暇】
完全週休2日(土・日)祝日、年末年始・夏期休暇 ※年間会社休日128日
年次有給休暇、病気有給休暇

【待遇】
昇給年1回
賞与年2回(夏季、冬季)
業績賞与制度あり(年1回、業績目標達成時のみ支給)
各種社会保険完備(健康保険、厚生年金保険、雇用保険、労働者災害補償保険)
交通費全額支給
退職金制度(確定給付年金制度、確定拠出年金制度) 
福利厚生俱楽部

【研修制度】
自己啓発プログラムサポート (英語研修やTOEIC受験料の補助)
社内オープンセミナーなど

Compelling Reasons to join us:

Your Attractive Compensation Package

Benefit from competitive salaries and attractive additional benefits.

Your Work-Life Balance

For a better balance between work and personal life, we support you with flexible working time models.

Your Development

We support your career with personalized training opportunities and promote your career development, for example, through our talent programs.

Your Contribution

Sustainability is part of our identity. We promote a dynamic culture of innovation where you can contribute your ideas and creativity.

Your International Environment

Immerse yourself in an intercultural work environment and work on exciting projects worldwide.

Your Health

We promote health and well-being with a variety of health offerings.

Diversity, Equity & Inclusion

Diversity, Equity & Inclusion

Syntegon is a globally operating company that values diversity. We explicitly welcome an environment where all employees, regardless of gender, age, background, religion, sexual orientation, gender identity, or special needs, are equally valued.

Meet the Team

Your career as Field Service Engineer at Syntegon
Your career as Field Service Engineer at Syntegon
Your career as Field Service Engineer at Syntegon
Your career as Field Service Engineer at Syntegon
Your career as a Field Service Engineer at Syntegon
Your career as a Field Service Engineer at Syntegon
Your career as Field Service Engineer at Syntegon
Your career as Field Service Engineer at Syntegon
Your career as Field Service Engineer at Syntegon
Your career as Field Service Engineer at Syntegon
Your career as Field Service Engineer at Syntegon
Your career as Field Service Engineer at Syntegon
More Videos
Your career as Field Service Engineer at Syntegon
Your career as Field Service Engineer at Syntegon
Your career as Field Service Engineer at Syntegon
Your career as Field Service Engineer at Syntegon
Your career as a Field Service Engineer at Syntegon
Your career as a Field Service Engineer at Syntegon
Your career as Field Service Engineer at Syntegon
Your career as Field Service Engineer at Syntegon
Your career as Field Service Engineer at Syntegon
Your career as Field Service Engineer at Syntegon
Your career as Field Service Engineer at Syntegon
Your career as Field Service Engineer at Syntegon

 

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Getting you onboard

Every company has its own culture and way of doing things. Our onboarding process allows you to get to know Syntegon and learn how we provide the highest standards in service.

Become an expert. Stay an expert.

When you grow and develop, the company does too. We believe that the best way to learn is on-the-job problem solving and training. Learn from a senior expert and try out new ways of solving problems supported by a mentor, your global colleagues, and technical advisors.

Our awards

My Job. My Passion.

Jomel
Jomel
Field Service Engineer, USA 

I like the complexity and diversity. Putting my technical attitude to the test.

Lee
Lee
Field Service Engineer, UK 

Our machines are the best in the packaging world, and I only want to work with the best.

Yllucius
Yllucius
Field Service Engineer, Südafrika

As a field service technician, you learn every day.

Russel 
Russel 
Field Service Engineer Manager, South Africa

I am not somebody that wants to do less. I want to do more.

 

Chen Qingwei
Chen Qingwei
Field Service Engineer, China 

Working at Syntegon feels like being a member of a large family.

 

Our application process

1. Online application
1. Online application

Apply online for one of our advertised vacancies. You can do this easily with your smartphone in just a few minutes.

2. Application review
2. Application review

We review your application with our colleagues from the specialized departments and will get back to you within a few days.

3. Getting to know each other
3. Getting to know each other

The first interview will be conducted via video interview. For the second interview, we would like to invite you to meet us in person.

4. Decision
4. Decision

We will discuss the next steps with you transparently and provide you with timely feedback on our decision.

Convinced?

Apply now!