NA Cleaning Validation Principal

我們做什麼

在 Kenvue，我們意識到日常護理的非凡力量。我們以一個多世紀的傳統為基礎，植根於科學，是標誌性品牌的品牌 - 包括您已經熟悉和喜愛的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科學是我們的熱情所在;關心就是我們的才能。

我們是誰

我們的全球團隊由 ~ 22,000 名才華橫溢的員工組成，他們的職場文化中，每個聲音都很重要，每一個貢獻都受到讚賞。 我們熱衷於洞察， 創新並致力於為我們的客戶提供最好的產品。憑藉專業知識和同理心，成為 Kenvuer 意味著每天有能力影響數百萬人。我們以人為本，熱切關懷，以科學贏得信任，以勇氣解決——有絕佳的機會等著您！加入我們，塑造我們和您的未來。有關更多資訊，請按兩下 here.

Role reports to：

位置：

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你會做什麼

The NA Cleaning Validation Principal is the NA leader for the oversight of cleaning and sanitization (C&S) procedures, development and validation across all segments for the NA Kenvue portfolio including cosmetic, nutritional, and drug product, as applicable.  This role is responsible for monitoring the cleaning and sanitization processes at our Internal Manufacturing sites, act as a SME (subject matter expert) and consultant for cleaning across our external manufacturing network and to ensure continued maintenance of the validated state.  In addition, this role will have global responsibility for all cleaning and sanitization procedures across all segments of the business. The person in this role is expected to provide a high degree of scientific expertise and leadership across the region. The individual provides departmental technical expertise and company leadership for cleaning activities while collaborating with Technical Operations, R&D, Quality and Operations to identify and address overall needs.

Key Responsibilities

• Provides oversight to the development and execution of cleaning and sanitization strategies for the NA internal manufacturing sites. Responsibilities include driving efficiencies, understanding existing limitations and developing technical solutions to address challenges and eliminate roadblocks.
• Leads the development of policy and procedures for the overall strategy for cleaning and sanitization for all segments and franchises globally
• Leads a global C&S Community of Practice to drive continuous improvement and enhancement of the C&S program
• Applies scientific principles to resolve technical challenges of high complexity while being able to articulate complex subject matter in clear, concise terms. Serves as a primary technical lead, on cross functional teams and sets technical direction, leads, and coordinates complex project activities and resources.
• Develop, plan, implement and/or coordinate major project activities in collaboration with other SME's, site and platform leadership or department management. Proposes and reviews program technical directions, benefits, costs, resource needs, schedules, risks, and risk mitigations.
• Identifies and stays abreast of emerging industry guidance related to cleaning and sanitization. Investigates and communicates innovation and trends.
• Develop recommendations on general validation guidelines and standards for processes and functional requirements.
• Oversee, write, review, and/or approve technical documentation, including but not limited to, validation documents, SOPs, Product Impact Assessments, Technical Justifications, manufacturing work instructions, and investigation (INV) reports. Contributes to defining department, project and / or program goals, tactics, and priorities. Defines objectives to achieve department, team, and individual goals/targets.
• Provides direction and mentorship to scientists, co-ops, and interns, as applicable.

What we are looking for

Required Qualifications

• Bachelor’s Degree is preferred in Pharmacy, Chemistry, Engineering, or related scientific field.
• 8+ years of industry experience is required.  Process knowledge related to all aspects of cleaning and sanitization is required.
• Previous experience in a healthcare manufacturing environment highly desired. GMP experience is preferred.

Desired Qualifications

• Proficient knowledge in cleaning and sanitization 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), as applicable.
• Has a proven track record of meeting project objectives by successfully managing, tracking and implementing successful strategies in regard to scope, quality, time and cost.
• Communicates effectively to all levels of the organization, including effectively presenting information and responding to questions or complex inquiries.
• In-depth understanding of the consumer goods manufacturing.
• Proficient knowledge and understanding of equipment design, cleaning procedures, analytical methods, sampling requirements, and in the collection and evaluation of data, from the cleaning design stage through commercial production.
• Proficient 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.
• Proficient in regulatory requirements in the development, validation, and manufacture of consumer cosmetic, nutritional, engineered and OTC drug products (regulatory agencies such as, FDA, MHRA, Health Canada, AIFA etc.).

對您有什麼好處

這考慮了許多因素，包括工作地點、候選人的技能、經驗、教育水準和其他與工作相關的因素

Kenvue 很自豪能成為一個機會均等的雇主。所有合格的申請人都將根據業績獲得就業考慮，不分種族、膚色、宗教、性別、性取向、性別認同、年齡、國籍或受保護的退伍軍人身份，並且不會因殘疾而受到歧視。