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栃木県の求人1,209件応募資格・募集要項・仕事内容を見る
生産技術（MSAT Execution）
- 給与
- 記載なし
- 勤務地
- 栃木県
- 休日
- 記載なし
- 雇用形態
- 記載なし
どんな仕事かAIによる生成
生産および洗浄プロセスのバリデーション、最適化、維持を担うサブジェクトマターエキスパートです。プロセス確認、継続的検証、技術移管、調査、継続的改善などを通じて、製品品質とサイトの安定供給に貢献します。
この求人に応募
応募資格
必須
Skill
- Knowledge of GMP/GDP and good documentation practices, with experience supporting internal/external audits.
- Cross-functional delivery and risk/project management: Proven ability to work effectively across functions to coordinate technical activities, manage priorities and mitigate risk in a GMP manufacturing environment.
- Technical communication and collaboration: Ability to influence through expertise, communicate complex technical information clearly, and work effectively with Operations, Quality, Engineering and other stakeholders.
- Results-oriented mindset and continuous improvement: Committed to achieving business and quality objectives through data-driven decision making, innovation, and a focus on continuous improvement.
- Problem-solving and critical thinking: Ability to analyze complex situations, identify practical solutions, and make informed decisions based on data and metrics.
- At least 5 years of experience in pharmaceutical industries.
- Education: bachelor’s degree or equivalent in Scientific field (e.g. Pharmaceutical Chemistry and Technologies, Chemistry, Biology)
- Legal right to work in Japan.
歓迎
- Technical manufacturing expertise: e.g. technical aspects of the Product Lifecycle including Scale Up, Technology Transfers, Technical Risk Assessments, Product Control Strategies, Process Capability/Robustness, QbD, Process/Cleaning validation, Contamination Control and change control
- Fluent spoken and written both Japanese and English.
募集要項最終確認 11/4
- 職種
- 生産技術
- 雇用形態
- 記載なし
- 給与
- 記載なし
- 勤務地
- 栃木県Imaichi
- 転勤
- Future scope of job and working location will be determined by company.
- 働き方
- 記載なし
- 業務の変更の範囲
- Future scope of job and working location will be determined by company.
- 就業場所の変更の範囲
- Future scope of job and working location will be determined by company.
- 経験年数
- 5年以上
- 学歴
- 大学卒業以上
- 掲載日
- 2026/10/13 06:15（23日前）
- 最終確認
- 2026/11/04 19:58（1日前）
仕事内容
Job Purpose
- The role serves as a subject matter expert responsible for validating, optimizing and maintaining robust manufacturing and cleaning processes to ensure consistent production of safe, effective and cost efficient products. This role provides technical expertise to drive process efficiency, compliance with regulatory and quality standards, and timely technical transfers and validations, while supporting investigations, continuous improvement and site readiness. Through strong cross functional collaboration and execution excellence, the role directly contributes to site supply reliability, product quality and overall business performance.
Key Responsibilities
- Provide subject matter expertise for process validation, verification and lifecycle maintenance activities for manufacturing and cleaning processes.
- Plan, execute and document process and cleaning validation activities to ensure manufacturing capability and prevent cross contamination.
- Support Continued Process and Cleaning Verification (CPV/CV) through monitoring of critical process parameters to maintain process control and reduce variability.
- Execute process confirmations and periodic product reviews to support the Product Control Strategy and ongoing compliance.
- Analyze process data and trends to identify improvement opportunities and support product and process optimization projects.
- Support technical transfers, equipment or IM qualification activities, and related assessments to enable successful new product introductions and changes.
- Lead or support root cause investigations and change impact assessments, ensuring effective corrective actions, appropriate technical rationale and compliant documentation. Collaborate with Operations, Quality, Engineering and other MSAT SMEs to balance compliance, cost and supply risk and to support audits and regulatory expectations.
- Author, review and maintain technical documents, protocols, reports and assessments required to support validated state and effective knowledge management.
- Ensure the provisions of the employer regarding Health, Safety and Environment regulations in their area of competence, in accordance with EHS&S Corporate Standards; in particular ensuring proper use of personal protection equipment and applying the proper escalation process in case of any unforeseen risk, for the appropriate actions to be taken.
この求人は、グラクソ・スミスクライン株式会社の採用ページの内容をAIが読み取って整理したものです。応募の前に採用ページの原文を確かめてください。データの集め方企業サイト
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