NA Cleaning Validation Principal

NA Cleaning Validation Principal

What we do

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated.  We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here.

Role reports to:

Tech Ops Process Science Leader - NA

Location:

North America, United States, Pennsylvania, Fort Washington

Work Location:

Hybrid

What you will do

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.).

What’s in it for you

$0.00 - $0.00

This takes into account a number of factors including work location, the candidate’s skills, experience, education level & other job-related factors.

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.