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生産技術エンジニアの求人582件
Sr. Staff Engineer - Polymer Biomanufacturing
掲載中・1日前に確認
- 給与
- 記載なし
- 勤務地
- 記載なし
- 休日
- 記載なし
- 雇用形態
- 記載なし
- 週4日 出社
どんな仕事か求人票をもとにAIがまとめたものです
The Sr. Staff Engineer, Polymer Biomanufacturing provides technical leadership for BD’s P4HB polymer production and related biomanufacturing activities. The role supports reliable GMP production, supplier oversight, validation, and continuous improvement, including coordination with vendors and cross-functional teams.
応募資格・募集要項・仕事内容を見るこの求人に応募
応募資格
必須
- The role requires knowledge of microbial fermentation, microbial product extraction and purification, GMP manufacturing environments, and product analysis.
- Experience with vendor qualification and contract manufacturing is essential.
- Master’s degree or higher in chemical engineering, biochemical engineering, biology, microbiology, polymer science, biomaterials, or a related technical discipline required.
EXPERIENCE
- Minimum of ten years of relevant experience in polymer production, bioprocessing, biomaterials manufacturing, or related regulated manufacturing.
- Experience with GMP or quality-system-controlled manufacturing performed by external suppliers or contract manufacturers.
- Experience with supplier qualification, validation, change control, deviations, batch record review, lot release, and technology transfer.
- Experience working with cross-functional teams in R&D, Quality, Supplier Quality, Regulatory, Procurement, Materials, Manufacturing, and external suppliers.
SKILLS
- Strong technical judgment and troubleshooting skills across complex production processes and suppliers.
- Ability to translate technical information into clear procedures, specifications, risk assessments, training, and quality documentation.
- Strong project management, communication, organization, and prioritization skills.
- Ability to influence cross-functional teams without direct authority.
- Strong understanding of GMP, quality systems, supplier quality, and regulatory documentation requirements.
歓迎
- Experience supporting medical device, pharmaceutical, biologic, or other regulated product manufacturing preferred.
募集要項最終確認 10/3
- 職種
- 生産技術エンジニア
- 雇用形態
- 記載なし
- 役職
- Sr. Staff Engineer
- 給与
- 記載なし
- 給与の詳細
- $161,400.00 - $258,200.00 USD Annual
- 勤務地
- USA MA - WoburnUSA RI - Warwick
- 働き方
- In-Office, Multiple LocationsFor most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
- 経験年数
- 10年以上
- 学歴
- 大学院修了以上
- 掲載日
- 2026/10/03 10:19（1日前）
- 最終確認
- 2026/10/03 21:23（1日前）
仕事内容
Job Description
- The Sr. Staff Engineer, Polymer Biomanufacturing provides technical leadership for BD’s P4HB polymer production and related biomanufacturing activities, supporting reliable GMP production, supplier oversight, validation, and continuous improvement.
RESPONSIBILITIES OF POSITION
- Manage approved vendors to schedule and oversee polymer production runs to meet production requirements.
- Partner with Procurement, Quality, Supplier Quality, Regulatory, R&D, Manufacturing, and external suppliers to forecast future production needs and support continuity of supply.
- Provide technical leadership for P4HB polymer production, including fermentation, purification, testing, release, and troubleshooting.
- Assess supplier deviations, nonconformances, OOS results, and process anomalies with cross-functional partners.
- Coordination of multiple vendors, contract review, compliance documentation, data evaluation, and technical reporting.
- Lead or support validation, supplier qualification, technology transfer, and change control activities.
- Develop and maintain GMP/QMS documentation, including specifications, procedures, work instructions, risk assessments, and validation reports.
- Monitor process and quality trends and lead improvements in robustness, efficiency, quality, sustainability, and supplier capability.
- Support future polymer and biomaterials initiatives, including new suppliers, process modifications, and customized polymer attributes.
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