Validation Scientist

Kenvue • Lititz, PA

2d • $72,675 - $102,600 • Onsite

About The Position

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.

Requirements

• 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).

Nice To Haves

• 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.

Responsibilities

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

Benefits

• Annual base salary for new hires in this position ranges: $72,675.00 - $102,600.00
• Competitive Benefit Package
• Paid Company Holidays
• Paid Vacation
• Volunteer Time & More!
• Learning & Development Opportunities
• Kenvuer Impact Networks

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level