Staff Engineer, Packaging Equipment

Kenvue Inc.; Fort Washington (Montgomery County); On-site; USD 111,000 - 156,000; Full time

Benefits offered by this job

競争力の福利厚生パッケージ

有給休日・有給休暇・ボランティアタイム詳細

学習と開発の機会

Kenvuer Impact Networks

Job summary

Kenvue Inc.は北米のフォートワシントン拠点で包装機器のStaff Engineerを募集します。あなたは仕様策定・開発・実装・検証を担い、資本計画と資産管理を統括します。部門横断のチームを指揮し、ラインの信頼性とOEE向上を推進します。

責任は機器導入・設備検証・変更管理・SOP作成・CAPA対応・トラブルシューティング等多岐にわたり、cGMP/FDA規制の適用と品質改善をリードします。英語とスペイン語のバイリンガル能力が望まれます。

Qualifications

• 機械・化学・電気など工学分野の学士号を有すること。
• 製薬・消費財企業での6年以上の経験が望ましい。
• cGMPとFDA規制の理解が必須。
• 英語とスペイン語のバイリンガル能力を有すること。

Responsibilities

• 設備導入・検証・変更管理を含む複数の設備プロジェクトを計画・実行する。
• 包装機器の設計要件・変更範囲を定義し、リスク評価を実施する。
• SOP作成・ CAPA対応・トラブルシューティングを実施する。
• クロスファンクショナルチームを指揮し、監査対応を推進する。

Skills

英語とスペイン語のバイリンガル

cGMPの知識

プロジェクト管理

技術文書作成

問題解決

Education

工学分野の学士号

Tools

MS Project

品質文書ツール

Job description

Kenvueは現在、a:

Staff Engineer, Packaging Equipment

私たちがしていること

Kenvueで、日常のケアの並外れた力を実感します。100年以上にわたる伝統を基盤に、科学に根ざした当ホテルは、ニュートロジーナ®、アヴェーノ®、タイレノール®、リステリン®、ジョンソンズ®、バンドエイド®など、すでにお馴染みのアイコニックなブランドを展開しています。科学は私たちの情熱です。ケアは私たちの才能です.

Who We Are

私たちのグローバルチームは~22,000人の優秀な人々で、すべての声が重要で、すべての貢献が評価される職場文化を持っています。私たちは洞察に情熱を注いでいます。 革新とお客様に最高の製品を提供することに取り組んでいます。専門知識と共感力を持つKenvuerであることは、毎日何百万人もの人々に影響を与える力を持つことを意味します。私たちは人を第一に考え、熱心に気を配り、科学で信頼を勝ち取り、勇気を持って解決します。そして、素晴らしい機会があなたを待っています!私たちと一緒に、私たちの、そしてあなたの未来を形作りましょう。詳細についてはをクリックしてくださいhere.

Role reports to:

Sr Manager, Engineering & Automation

Location:

North America, United States, Pennsylvania, Fort Washington

勤務地:

フルオンサイト

あなたがすること

The Staff Engineer, Packaging Equipment, is responsible for technical support, including specification, development, implementation, and assurance of a qualified state for packaging equipment. Aligns packaging equipment requirements with the site’s needs, ensuring customer service, and quality/compliance goals. Responsible for project’s capital plan and equipment asset management, and reliability. Manages capital appropriation approval for assigned projects and spending management. Leads cross functional teams that includes equipment, automation, and packaging engineers to deliver key projects driving business results in alignment with the site goals and objectives.

Responsibilities:

• Plan and execute multiple and/or major equipment and validation projects concerned with life cycle management initiatives and develop risk mitigation strategies to deliver project commitments.
• Understand and improve assigned processes and various equipment technologies across multiple locations simultaneously. This person will work with and benchmark sites to provide the best-in-class processes for the company.
• Plan and execute equipment and validations strategies aligned to the consumer asset management strategies to assigned areas within company. Responsibilities include understanding existing limitations and developing technical solutions to eliminate waste.
• Lead equipment installation, qualification, validation and start up for assigned projects, and communicate potential issues and give clear direction to site teams to ensure successful project execution.
• Plan and execute equipment strategies by providing engineering solutions, technical advice, and assistance to Operations, Packaging and other departments as required.
• Develop and execute plans related to equipment that maintain high levels of Operational Equipment Efficiency (OEE) to assigned areas. Drives value through identifying and executing multi-site projects by improving compliance, quality, efficiency, and cost.
• If assigned to packaging area, support and/or lead the development and assessment of the following types of information to support package development and life cycle management initiatives, including but not limited to: design requirements, definition of the scope of change, packaging and equipment solution proposals, prior knowledge and knowledge gap assessments, risk assessments, test plans, and test results analysis and conclusions.
• Lead, develop, write, and gain cross functional alignment of required documentation for equipment systems qualifications and/or validations.
• Support and /or lead the execution of line trials, engineering studies, equipment qualification and process performance qualification.
• Ensure all trainings and if applicable, those of direct reports, are current and successfully completed prior to the execution of specific work activities.
• Support and/or lead the development, execution and/or review of change controls for equipment and validation related changes.
• Provide technical support and/or lead equipment/process troubleshooting related to equipment troubleshooting and improvements, use applicable tools (e.g., Kepner Tregoe, DMAIC, etc) to facilitate root cause identification, write and/or approve reports as required (technical memos, Non-Conformance (NC), and Corrective/Preventive Actions (CAPAs).
• Prepares or approves Equipment Periodic Review.
• Writes or approves SOPs based on area of experience and training. Provides technical advice on SOP’s, policies, and procedures.
• Manage investigations, CAPAs, and APR data collection, analysis, and review/approval.
• Reviews and approves Commissioning and Qualification documentation such as plans, protocols, and reports as required.
• Assist with reviews and approval of Computer System Validation documentation as required.
• Reviews and approves Package Validation documentation such as protocols and reports as required.
• Proficiency in Project Management tools. Independently manage projects from concept to post implementation for more complex projects. Demonstrates the methodology to solve problems independently.
• Provides technical direction to external resources (e.g. designers, suppliers, contractors, consultants).
• Serve as technical subject matter expert regarding changes/improvements/CIPs and sustainability.
• Leads a technical team or primary technical lead on cross functional teams. Ability to lead and coordinate project activities, resources, etc.
• May provide direction and mentorship to Co-ops and entry level engineers.
• Effectively influences people, multiple projects, and tasks of various complexities.
• Solves difficult and complex technical issues that have substantial impact on product quality and business outcomes.
• Maintains training proficiency on cGMPS, SOP’s, testing procedures, and data analysis as required

Requirements:

• Education: Bachelor of Science degree (or equivalent) in Engineering required. Chemical, Mechanical, Electrical or any other engineering discipline is required. Advanced degree preferred.
• Experience: 6+ years of experience is required. Experience with a pharmaceutical or consumer products company is preferred. Relevant experience in engineering, packaging, technical, and/or operations experience is required. Knowledge of cGMPs and Good Documentation Practices is required. Experience working in FDA/cGMP compliance environment preferred.
• Knowledge, Skills, and Abilities: Bilingual (English and Spanish) with excellent verbal, writing and technical writing skills in In-depth understanding of current Good Manufacturing Practices (cGMP) and FDA regulations. Awareness of quality assurance methodologies, risk management, and compliance auditing. Strong knowledge with manufacturing processes, including packaging equipment, utilities, and automation systems.
• Strong verbal and written communication abilities across technical and non-technical audiences, including technical writing and documentation. Proficient in Microsoft Office Suite (Excel, Word, PowerPoint) for reporting, analysis, and presentations. Experience in equipment installation, troubleshooting, commission, qualification and validation. Basic knowledge of client/server architecture, network connectivity, and IT infrastructure in regulated environments. Effective project management and time management skills, with the ability to prioritize tasks under pressure.
• Demonstrated ability to communicate effectively with technical and non-technical personnel. Ability to lead cross-functional teams and drive continuous improvement initiatives. Capable of making sound decisions based on data and regulatory requirements. Able to work independently with minimal supervision in fast-paced environments. Takes initiative and exercises good judgment in problem-solving and operational execution.
• Certifications/Licenses: Six Sigma Green Belt/Black certification preferred. Professional Engineer (PE) license is preferred. Project Management preferred.
• Leadership: Demonstrated solid competencies on the values and behaviors to effectively contribute to the transformation of the scope of work. Ability to work as a Team Player.

それは何ですか

このポジションの新入社員の年間基本給の範囲:

$110,500.00 - $156,000.00

これは、勤務地、候補者のスキル、経験、教育レベルなど、多くの要素を考慮に入れています。その他の仕事関連の要因.

• 競争力のある福利厚生パッケージ*
• 有給の会社の休日、 有給休暇、ボランティアタイム&詳細!
• 学習&開発の機会
• Kenvuer Impact Networks
• このリストは場所/地域によって異なる場合があります

*注:Kenvueの合計報酬には、給与、ボーナス(該当する場合)、および福利厚生が含まれます。あなたのタレントアクセスパートナーは、採用および採用中に、関連する場所の報酬提供総額と特定の給与範囲について詳しく共有することができます。採用プロセス.

Kenvueは機会均等雇用者であることを誇りに思っています。人種、肌の色、宗教、性別、性的指向、性同一性、年齢、出身国、または保護された退役軍人の地位に関係なく、すべての資格のある応募者は、能力に基づいて雇用の検討を受け、障害に基づいて差別されることはありません。

障害を持つ個人の方は、宿泊施設のリクエスト方法について、私たちの障害者支援ページを確認してください。