Sr. Engineer, C&Q

Kenvue Inc.; Lititz (Lancaster County); On-site; USD 114,000 - 140,000; Full time

Benefits offered by this job

Competitive benefits

Paid company holidays

Job summary

KenvueはNorth Americaのレジデンスで、C&QのSenior Engineerとしてサイトのプロジェクトに参画します。C&Qの基準、手順、規制要件を技術的に指導し、製品ライフサイクルプロセスへ適用します。品質と製造部門と連携し、C&Qの実践と指標を強化します。

責任には・現場の検証マスタープランの実行計画の作成・承認・スケジュール管理・標準作業手順の作成・レビューが含まれ、適切な会議で成果を報告します。英語とスペイン語のバイリンガル能力が望ましいです。

Qualifications

• この roles requires GMP-related training and strict adherence to procedures.
• 品質と規制の遵守を保証する能力が求められます。
• 部門横断的な協働とエンジニアリング問題解決能力が必要です。

Responsibilities

• C&Q基準・手順・リスク評価・規制要件の技術的指導を提供する。
• VMPの実施計画を作成・レビューする。
• 現場のプロジェクトをリードまたは支援し、適用可能なガバナンスへ報告する。

Skills

GMP training

Quality compliance

Cross-functional collaboration

Engineering problem-solving

Education

Bachelor’s degree in Engineering

Tools

Validation documents

Job description

Kenvueは現在、a:

Sr. Engineer, C&Q

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。詳細についてはここ.

Role reports to: Sr Manager Engineering and Automation

Location: North America, United States, Pennsylvania, Lititz

勤務地: フルオンサイト

あなたがすること

The Engineering Commissioning and Qualification (C&Q) Senior Engineer supports and completes site projects requiring C&Q. This role provides technical guidance on C&Q standards, procedures, risk assessments, regulatory requirements, practices, and execution. The Senior Engineer also contributes C&Q requirements to the Product Life Cycle process and collaborates across Engineering—including the Solids and Packaging Technology Platforms—as well as with Quality and Manufacturing teams to strengthen C&Q practices, procedures, and performance measures. As needed, the role supports or leads the implementation of site, regional, and global project and automation strategies that affect C&Q processes. The Senior Engineer supports the site Validation Master Plan (VMP) by developing implementation plans and schedules, authoring or reviewing sub-volumes and supplements, and maintaining C&Q performance metrics. The role also presents C&Q execution strategies, deviations, outcomes, and metrics to applicable site or regional governance bodies and participates in other meetings as needed.

Key Responsibilities

Under limited supervision and in accordance with all applicable federal, state, and local laws and regulations, as well as company policies, procedures, and guidelines, this position:

• Ensures quality and compliance in all actions by:
  • Completing GMP training according to the schedule designated for the role.
  • Strictly adhering to all procedures applicable to the role.
  • Demonstrating the highest level of integrity in all tasks performed.
  • Promptly identifying and reporting workplace deviations and seeking appropriate corrective action.
  • Supporting employee involvement and a commitment to doing the job right the first time.
• Ensures all training in assigned curricula is completed before execution.
• Conducts all internal and external negotiations and activities in accordance with current business conduct principles and ensures these principles are upheld.
• Complies with requirements established by the Environmental Health and Safety (EHS) Program and ISO 14001, including:
• Completes required EHS training and follows applicable policies and procedures.
• Maintains a safe work area and environment by following and promoting rules and procedures related to:
  • Use of personal protective equipment.
  • Fire protection.
  • Reporting spills, including hazardous waste, incidents, and near misses.
  • Compliance with environmental permits and action plans, as applicable to supervisors and managers.
  • Applicable EHS programs, including forklift operations, ergonomics, Lockout/Tagout, and Process Safety Management.
• Encourages and supports peer and employee involvement in EHS considerations for changes affecting safety or the environment, as applicable to exempt employees, supervisors, and managers.
• Generates metrics and verifies employee participation in EHS initiatives and requirements, as applicable to supervisors.
• Promotes employee participation in the site Environmental Management System (ISO 14001), Process Safety Management, and other EHS initiatives, as applicable to management.
• Participates in the site’s waste-reduction and recycling programs.
• Participates in energy-reduction and other environmental protection initiatives.
• Maintains safe behavior in the work area.
• Actively contributes to achieving the organization’s EHS goals and objectives.
• Monitors EHS performance within the work area, as applicable to supervisors and managers.
• Adheres to the EHS business plan for the work area.
• Reports unsafe working conditions or risks and initiates corrective action plans as appropriate.
• Immediately notifies the supervisor of any workplace incident or accident, including an injury or occupational illness. The supervisor or manager must submit an Incident Report within 24 hours of the event.
• Actively participates in the work area’s Ergonomic Exercise Program.
• Provides necessary resources and ensures timely completion of safety-related matters, as applicable to supervisors and managers.
• Maintains in-depth knowledge of current validation practices across the industry.
• Ensures established procedures are followed during all C&Q activities.
• Participates in and, as applicable, leads cross-functional teams to support and complete projects and establish consistent, harmonized validation processes and procedures across company manufacturing sites.
• As applicable, takes a leadership role in company forums focused on validation standards and guidelines.
• Authors and approves standard operating procedures and validation documents as the technical subject-matter expert.
• Ensures site C&Q activities are documented consistently and promptly in the Validation Master Plan and provides metrics on performance against documented plans.
• Informs senior management of the validation status and issues requiring prioritization.
• Leads, completes, and reviews the progress of approved projects, providing ideas and support to resolve issues that affect timely completion and achievement of project goals.
• Participates in audits and supports interactions with regulatory agencies.
• Provides technical support for investigations and the resolution of process deviations, including complex investigations.
• Assists in establishing departmental resource strategies and plans to meet business requirements and approved priorities.
• Influences project and resource direction through collaboration with business partners, manufacturing sites, and site validation teams.
• Supports the project capital plan, monthly and quarterly expenditures, cash-flow forecasts, contingencies, and scope management related to C&Q activities.
• Uses applicable project management tools—including project timelines, kickoff meetings, risk and mitigation logs, issue and action logs, decision logs, change logs, and stabilization plans—to manage projects and base-business activities.
• Supports the Engineering & Automation Manager and Engineering team in developing and maintaining the long-range financial plan (LRFP) and integrating it with regional, global, and automation strategies for C&Q.
• Supports regional and global C&Q strategies and creates a site-specific roadmap that includes standardization and integration with automation strategies.
• As applicable, provides supervision and guidance to less-experienced engineers.
• Oversees the work of contractors.
• Performs other related duties as required.

Qualifications

• Bachelor’s degree in engineering or a related scientific discipline required; advanced degree preferred.
• Four or more years of relevant experience required.
• Experience in a pharmaceutical or consumer products company preferred.
• Relevant engineering, technical, or operations experience required.
• Knowledge of current Good Manufacturing Practices (cGMPs) and Good Documentation Practices required.
• Experience working in an FDA-regulated, cGMP-compliant environment preferred.
• Excellent verbal, written, and technical writing skills required. Bilingual proficiency in English and Spanish preferred.
• Ability to interpret and apply cGMP requirements, use mathematics and analytical skills effectively, and apply knowledge of computer system validation.
• Basic proficiency with Microsoft Office applications, including Excel, PowerPoint, and Word.
• Ability to make sound decisions based on available facts while meeting established deadlines and priorities.
• Demonstrated leadership skills.
• Strong knowledge of current quality assurance techniques.
• Ability to work independently, with minimal supervision, and under pressure.
• Demonstrated initiative and sound judgment in performing assigned duties.
• Six Sigma Green Belt or Black Belt certification preferred. FPX or PMP certification preferred.
• Professional Engineer license preferred.
• Ability to travel within and outside North America.
• Ability to work additional hours and respond to emergency calls that may require returning to the site outside regular business hours.
• Ability to support other departments and projects based on business needs.

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:

$90,100.00 - $127,200.00

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。