Tech Ops Scientist - Pilot Plant

Kenvue • Lititz, PA

2d • Onsite

About The Position

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.

Requirements

• Basic scientific knowledge
• Solid understanding of the principles of manufacturing processes
• Passion for innovation and continuous improvement
• Ability to implement technical aspects of projects
• Ability to report metrics
• Ability to interact with multi-functional teams
• GMP training
• Strict compliance with procedures and GDP
• Highest level of integrity
• Ability to identify, report, and seek corrections for deviations
• Employee involvement and commitment to doing the job right the first time
• Ability to use scientific principles to resolve moderately sophisticated technical challenges
• Ability to articulate complex subject matter in clear, concise terms
• Support execution of or lead small to moderately sized project tasks per established timeline
• 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.
• CAPA implementation and follow up to ensure CAPA effectiveness
• 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.
• 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.

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, 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.
• 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.

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
• Learning & Development Opportunities
• Kenvuer Impact Networks

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed