Scientist, Pilot Plant

Kenvue Inc.

Lititz (Lancaster County)

On-site

USD 73,000 - 103,000

Full time

9 days ago

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Benefits offered by this job

Competitive benefits

Paid holidays and vacation

Learning & development

Kenvue Impact Networks

Job summary

Kenvueは北米のLititz拠点で、パイロットプラントの科学者として消費者向け製品の製造プロセスを推進します。小規模バッチの生産、臨床物資の準備、他部門と連携して技術課題を解決します。

品質と規制遵守を徹底し、GMPトレーニングを受け、データ分析・報告・CAPA対応・技術文書作成を担います。経験豊富なチームと共に継続的改善とリーダーシップを発揮してください。

Qualifications

Bachelor’s degree in Pharmacy, Chemistry, Engineering, or related field
2+ years of industry experience
GMP experience preferred
Process knowledge related to process/product development

Responsibilities

Ensure quality and compliance in GMP/EHS training and procedures
Apply scientific principles to resolve moderately sophisticated technical challenges
Lead small-to-moderate project tasks for pilot-scale batches and clinical supplies
Manage batch requests in the pilot plant
Coordinate clinical supplies execution and repacking
Assist in experimental design, data collection, and reporting
Support CAPA investigations and corrective actions
Write technical documentation (MWI, Fill Records, Cleaning Procedures)
Mentor contractors and provide direction as needed

Skills

GMP knowledge

Analytical skills

Technical writing

Communication

Problem solving

Lean principles

Education

Bachelor’s degree in Pharmacy, Chemistry, Engineering, or related field

Tools

MS Word

Excel

Project

Job description

Scientist, Pilot Plant

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 Scientist supports Technical Operations R&D Pilot Plant for a broad range of pilot scale consumer cosmetics, OTC drug products, and OTC monograph drug products. Primary activities require the use of basic scientific knowledge while developing a solid understanding of the principles of manufacturing processes and a passion for innovation and continuous improvement. This individual is expected to implement technical aspects of projects, report metrics, and interact with multi-functional teams to implement projects.

Additionally, the Scientist will ensure quality and compliance through GMP training, adhere to strict compliance with procedures and GDP, 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: Attending GMP / EHS&S training; Adhering to strict compliance with procedures applicable to the role.; Exercising the highest level of integrity in the tasks they perform.; In a timely and prompt manner, identifying, reporting, and seeking correction for deviations noted in the workplace.; Accepting the behavior of employee involvement and commitment to doing the job right the first time.
Uses scientific principles to resolve moderately sophisticated technical challenges while being able to articulate complex subject matter in clear, concise terms.
Support execution of or lead small to moderately sized project tasks per established timeline, including any activities associated with production of Pilot scale batches and Clinical Supplies operations.
Work with project teams to manage and execute batch requests in the pilot plant
Responsible for Clinical Supplies Project Execution and Coordination including repacking and labeling operations for clinical supplies
Support the execution of the planned experimental design (i.e., sample collection, in-process testing, sample management, etc.).
Support with report preparation by compiling and analyzing and summarizing data using appropriate analysis techniques.
Support change control deliverables/documentation, investigations, and corrective/preventative actions.
Support or lead conducting investigations related to product out of specification or process deviation, stability deviation, consumer complaints, and other investigations as applicable.
Conduct laboratory experimentation as needed related to investigations and root cause analysis.
Support or lead in conducting troubleshooting of scale-up issues, root cause analysis, and remediation for technical-related issues. Corrective Action and Preventative Action (CAPA) implementation and follow up to ensure CAPA effectiveness to address investigation and the root causes related to process deviation, stability, out of specification, out of trend, out of expectation, complaints, and others as applicable.
Support or lead in manufacturing process improvements through data analysis, identification of critical process parameters, the proposal of alternate process modifications, assistance in conducting DOE to determine the best processes.
Support in writing technical documentation including but not limited to Manufacturing Work Instructions, Fill Records, Cleaning Procedures, Technical Justifications, and INV reports.
Works with general/moderate direction. Provide direction and mentorship to contractors.
Decisions made at this level are limited in scope and authority.
Support and execute End to End Pilot Tasks including material management, cleaning and sanitization of small-scale equipment, labeling, shipping, document control/closure, etc.
May assist in process or equipment validation.

Qualifications

Bachelor’s Degree is preferred in Pharmacy, Chemistry, Engineering, or related scientific field.
2+ years of industry experience is required
Experience within the Consumer, OTC, or Pharmaceutical industry is preferred. GMP experience is preferred.
Process knowledge related to process/product development is required.
General knowledge of product characteristics and their correlation with product/raw material performance and performance requirements of specific products or raw materials and the customer needs.
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 the 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. Tools include- 5S, Visual Management, Mistake proofing, kanban’s/ 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 of regulatory requirements in the development, validation, and manufacture of consumer cosmetic and OTC monograph drug products (regulatory agencies such as, FDA, MHRA, Health Canada, AIFA etc.).
Strong analytical skills are required. Excellent technical writing skills are required. Experience with MS Word, Excel and Project software packages is required. Excellent interpersonal, influencing, communication, listening, negotiating and problem-solving/decision-making skills are preferred.