Validation Scientist

Validation Scientist

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:

Tech Ops Senior Manager Process Science

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 Validation Scientist supports the organization for a broad range of validation projects for consumer cosmetic and OTC drug products. Primary responsibilities are to support and execute validation activities related to process, package and cleaning validations at internal manufacturing sites. This individual applies basic scientific knowledge while developing a solid understanding of the principles of manufacturing processes and validation practices to demonstrate a passion for innovation and continuous improvement.

Working under general/moderate direction, this individual will collaborate cross-functionally with Operations, Marketing, Quality Assurance, Research and Development (R&D), and other functions as needed, to provide technical support in the development, and implementation of technical solutions for cost reduction and critical initiatives related to validation. This individual is expected to implement technical aspects of projects, report metrics, and interact with multi-functional teams to implement projects. 

Additionally, the Validation Scientist will ensure quality and compliance through GMP training, adhere to strict compliance with procedures, exercise the highest level of integrity in tasks performed, identify, report, and seek corrections for deviations noted in the workplace and embrace a behavior of employee involvement and commitment to doing the job right the first time. 

Key Responsibilities: 

• Ensure quality and compliance in all actions by:
  o Attending GMP / EHS&S (Environmental, Health, Safety & Sustainability) training. 
  o Adhering to strict compliance with procedures applicable to the role. 
  o Exercising the highest level of integrity in the tasks that they perform. 
  o Identifying, reporting, and seeking correction for deviations noted in the workplace in a timely and prompt manner. 
  o Accepting a behavior of employee involvement and commitment to doing the job right the first time. 

• Creates/ maintains Site Validation Master Plan (VMP) and supports the maintenance of the validated status of OTC drug products, Cosmetic products, and medical devices, as applicable.

• Manages the validation execution for the introduction and/or transfer of manufacturing processes, packaging processes, and/or cleaning processes for OTC, Cosmetic, Engineered and/or medical device products, as applicable.

• Develops technical risk assessment, validation protocol and validation report in conjunction with the validation team member or SMEs.

• In collaboration with R&D or Tech Transfer team, supports the identification of critical process parameters, critical quality attributes and process control strategy, as per relevant procedures and product requirements, and ensures inclusion in protocols.

• Executes sampling plan for the validation protocol. 

• Executes validation activities according to the schedule in the VMP or validation plan. 

• Executes data analysis of validation results and prepares the validation report. 

• Executes training on the validation protocol to the manufacturing team as required for effective execution.

What we are looking for

Required Qualifications

• A minimum of a Bachelor’s degree is required.

• 2+ years of industry experience is required.

• Knowledge related to manufacturing processes and validation is required.

• General knowledge of scientific principles for liquid/semi-solid formulation development (i.e., solution, suspension, semi-solid), solid dosage development (i.e., immediate, and delayed release), and other formulation development (i.e., Nasal Spray, Eye drops, Lozenges, and sterile products), engineered products and devices as applicable

• General understanding of process equipment and in-process control instruments. 

• General process knowledge in a few of the processes such as Mixing, Filling, Liquid dosage, Solid dosage, Liquid Packaging, Scale-up, Technology Transfer, Continued Process Verification, Process Development, as applicable.

• General knowledge and understanding of equipment design, cleaning procedures, analytical methods, sampling requirements, and in the collection and evaluation of data, from the process design stage through commercial production.

• General knowledge and ability to apply selected Lean tools to a situation - including: 5S, Visual Management, Mistake proofing, Kanban / rhythm wheels, and other Lean principles.

• General knowledge of statistical methods such as Six Sigma, statistical tools for data analysis. (i.e., CpK, Probability of failure), and risk management tools (FMEA, etc.).

• General knowledge and understanding of the Root Cause Analysis tools such as brainstorming, cause and effect analysis, fishbone diagrams, 5 why's, failure mode, effect analysis, RATIO, and others as applicable.

• General knowledge of regulatory requirements in the development, validation, and manufacture of consumer cosmetic, Engineered, OTC drugs, and/or medical device products (regulatory agencies such as FDA, MHRA, Health Canada, AIFA, etc.),

• General understanding of analytical skills is required.

• Competent technical writing skills are required - Experience with MS Word, Excel and moderate statistic software packages is required.

• Knowledge on creation of validation protocols and reports, supporting process/packaging scale-up and validation (e.g., pilot, characterization, and validation activities).

Desired Qualifications 

• Bachelor’s Degree is preferred in Pharmacy, Chemistry, Engineering, or related scientific field.

• Experience within the Consumer, OTC, or Pharmaceutical industry.

• GMP validation experience.

• Excellent interpersonal, influencing, communication, listening, negotiating and problem-solving/decision-making skills.

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それは何ですか

$72,675.00 - $102,600.00

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.

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。