Staff Engineer, Packaging Equipment

Kenvue•Fort Washington, PA

2d•$110,500 - $156,000•Onsite

About The Position

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. 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.

Requirements

Bachelor of Science degree (or equivalent) in Engineering required. Chemical, Mechanical, Electrical or any other engineering discipline is required.
6+ years of experience is required.
Experience with a pharmaceutical or consumer products company is preferred.
Relevant experience in engineering, packaging, technical, and/or operations experience is required.
Knowledge of cGMPs and Good Documentation Practices is required.
Experience working in FDA/cGMP compliance environment preferred.
Bilingual (English and Spanish) with excellent verbal, writing and technical writing skills in In-depth understanding of current Good Manufacturing Practices (cGMP) and FDA regulations.
Awareness of quality assurance methodologies, risk management, and compliance auditing.
Strong knowledge with manufacturing processes, including packaging equipment, utilities, and automation systems.
Strong verbal and written communication abilities across technical and non-technical audiences, including technical writing and documentation.
Proficient in Microsoft Office Suite (Excel, Word, PowerPoint) for reporting, analysis, and presentations.
Experience in equipment installation, troubleshooting, commission, qualification and validation.
Basic knowledge of client/server architecture, network connectivity, and IT infrastructure in regulated environments.
Effective project management and time management skills, with the ability to prioritize tasks under pressure.
Demonstrated ability to communicate effectively with technical and non-technical personnel.
Ability to lead cross-functional teams and drive continuous improvement initiatives.
Capable of making sound decisions based on data and regulatory requirements.
Able to work independently with minimal supervision in fast-paced environments.
Takes initiative and exercises good judgment in problem-solving and operational execution.

Nice To Haves

Advanced degree preferred.
Six Sigma Green Belt/Black certification preferred.
Professional Engineer (PE) license is preferred.
Project Management preferred.

Responsibilities

Plan and execute multiple and/or major equipment and validation projects concerned with life cycle management initiatives and develop risk mitigation strategies to deliver project commitments.
Understand and improve assigned processes and various equipment technologies across multiple locations simultaneously. This person will work with and benchmark sites to provide the best-in-class processes for the company.
Plan and execute equipment and validations strategies aligned to the consumer asset management strategies to assigned areas within company. Responsibilities include understanding existing limitations and developing technical solutions to eliminate waste.
Lead equipment installation, qualification, validation and start up for assigned projects, and communicate potential issues and give clear direction to site teams to ensure successful project execution.
Plan and execute equipment strategies by providing engineering solutions, technical advice, and assistance to Operations, Packaging and other departments as required.
Develop and execute plans related to equipment that maintain high levels of Operational Equipment Efficiency (OEE) to assigned areas. Drives value through identifying and executing multi-site projects by improving compliance, quality, efficiency, and cost.
If assigned to packaging area, support and/or lead the development and assessment of the following types of information to support package development and life cycle management initiatives, including but not limited to: design requirements, definition of the scope of change, packaging and equipment solution proposals, prior knowledge and knowledge gap assessments, risk assessments, test plans, and test results analysis and conclusions.
Lead, develop, write, and gain cross functional alignment of required documentation for equipment systems qualifications and/or validations.
Support and /or lead the execution of line trials, engineering studies, equipment qualification and process performance qualification.
Ensure all trainings and if applicable, those of direct reports, are current and successfully completed prior to the execution of specific work activities.
Support and/or lead the development, execution and/or review of change controls for equipment and validation related changes.
Provide technical support and/or lead equipment/process troubleshooting related to equipment troubleshooting and improvements, use applicable tools (e.g., Kepner Tregoe, DMAIC, etc) to facilitate root cause identification, write and/or approve reports as required (technical memos, Non-Conformance (NC), and Corrective/Preventive Actions (CAPAs).
Prepares or approves Equipment Periodic Review.
Writes or approves SOPs based on area of experience and training. Provides technical advice on SOP’s, policies, and procedures.
Manage investigations, CAPAs, and APR data collection, analysis, and review/approval.
Reviews and approves Commissioning and Qualification documentation such as plans, protocols, and reports as required.
Assist with reviews and approval of Computer System Validation documentation as required.
Reviews and approves Package Validation documentation such as protocols and reports as required.
Proficiency in Project Management tools. Independently manage projects from concept to post implementation for more complex projects. Demonstrates the methodology to solve problems independently.
Provides technical direction to external resources (e.g. designers, suppliers, contractors, consultants).
Serve as technical subject matter expert regarding changes/improvements/CIPs and sustainability.
Leads a technical team or primary technical lead on cross functional teams. Ability to lead and coordinate project activities, resources, etc.
May provide direction and mentorship to Co-ops and entry level engineers.
Effectively influences people, multiple projects, and tasks of various complexities.
Solves difficult and complex technical issues that have substantial impact on product quality and business outcomes.
Maintains training proficiency on cGMPS, SOP’s, testing procedures, and data analysis as required.