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 GmbH; Madrid; Presencial; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

製薬業界の大手企業が、自動化機械のGMP検証を担当するフィールドエンジニアを求めています。応募者は、3年の経験があり、技術専門学校または大学を卒業し、TOEICスコア500以上でコミュニケーション能力が求められます。フレックスタイム制度と完全な交通費支給があります。

Servicios

年2回のボーナス

完全交通費支給

年間128日の休日

Formación

• 3年以上のフィールドエンジニアリング経験
• TOEICスコア500以上
• 英語メールや文章の理解に不安がないこと

Responsabilidades

• GMP規則に基づく機械の検証を行う
• インストール検査を実施する
• 運用検査を通じて規則遵守を確認する

Conocimientos

GMP（医薬品適正製造基準）の知識

高いコミュニケーション能力

チームワーク

計測機器の知識

PLCプログラミングの知識

Educación

技術専門学校または大学卒

Herramientas

PLC

PC

LAN

Descripción del empleo

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。

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、“CenterofCompetence”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。

Syntegon Technology is a leading global process and packaging technology provider. Around 5,800 colleagues in more than 15 countries work for the Syntegon Group on intelligent and sustainable technologies for the pharmaceutical and food industries.

At Syntegon Technology K.K. (Japan) we provide a wide range of services to meet customer needs, including sales of domestically manufactured and imported machines for the Japanese pharmaceutical and food markets, as well as packaging materials, validation, and comprehensive services. We are located in Tokyo (HQ), Osaka and Saitama (R&D and manufacturing) with around 200 passionate colleagues.

Your duties

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。

GMPの規則に合致しているものかどうかの確認。（

• 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 。

As one of the world's largest manufacturers of packaging and inspection machines for pharmaceutical manufacturing, you will be responsible for the validation of automated machines such as pharmaceutical cleaning, sterilization, and filling machines, mainly our injectable filling lines.

During validation, you will check whether the machines comply with GMP, a regulation for ensuring drug safety. The main tasks are as follows.

1) Installation qualification inspection, which checks whether the installed machines meet the design specifications. (Check important parts, check piping gradients, etc.)

2) Calibration, checking whether instrumentation equipment such as target temperature sensors are within the compliance standards.

3) Operation qualification inspection : Actually operate the machines checked in 1) and 2) to check whether they comply with GMP regulations. (

Main inspections : Washing machine : Check cleaning function; Tunnel sterilizer : Check air speed, HEPA

filter leaks, cleanliness, temperature distribution; Filling machine : Check filling accuracy.

Each inspection uses the necessary measuring equipment (calibrated and traceable to national standards).

Documents for inspections 1), 2), and 3) are created, and the inspections are carried out in accordance with the created documents.

Your profile

3年以上

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）

PLC、PC、OS、LAN

GMP（医薬品適正製造基準）の知識

Graduate from a technical college or university : Mechanical engineering (basic knowledge of electricity, machinery, mathematics, and physics)

Experience in field engineering at a manufacturing company : 3 years or more

Able to work on business trips within Japan

High mobility, teamwork, and communication skills

Native in Japanese language, TOEIC score of 500 or higher (no problem with reading and understanding English emails and texts)

Knowledge of measuring instruments

Knowledge of machine control : programming, PLC, PC, OS, LAN

Knowledge of GMP (Good Manufacturing Practices)

Qualification as an electrician

More information

1464-4（最寄駅：東武東上線「つきのわ駅」より徒歩10分）

8 : 4517 : 30（休憩12 : 1513 : 00）所定労働時間8時間

2日（土・日）祝日、年末年始・夏期休暇※年間会社休日128日

2回（夏季、冬季）

1回、業績目標達成時のみ支給）

TOEIC受験料の補助）

Work location)

Competence Center Japan and Vision Technology Office

1464-4 Tsukinowa, Namekawa-cho, Hiki-gun, Saitama Prefecture (nearest station : 10-minute walk from Tsukinowa Station on the Tobu Tojo Line)

Working hours)

8 : 45-17 : 30 (break 12 : 15-13 : 00) 8-hour work schedule

Flextime and telecommuting systems available

Salary)

Pay will be based on experience and ability

Holidays)

2 days off per week (Saturday and Sunday), public holidays, New Year's holidays, summer holidays

128 company holidays per year

Annual paid leave, paid sick leave

Benefits)

Salary increase once a year

Bonus twice a year (summer, winter)

Performance bonus system (paid once a year, only when performance targets are achieved)

Full social insurance (health insurance, employee pension insurance, employment insurance, worker's accident compensation insurance)

Full transportation expenses paid

Retirement benefits system (defined benefit pension system, defined contribution pension system)

Welfare club

Training system)

Self-development program support (subsidy for English training and TOEIC exam fees)

In-house open seminars, etc.

J-18808-Ljbffr