Staff Engineer, Packaging Equipment

Role reports to:
Sr Manager, Engineering & Automation

Location:
North America, United States, Pennsylvania, Fort Washington

Work Location:
Fully Onsite

What you will do

The Staff Engineer, Packaging Equipment, is responsible for technical support, including specification, development, implementation, and assurance of a qualified state for packaging equipment. Aligns packaging equipment requirements with the site's needs, ensuring customer service, and quality/compliance goals. Responsible for project's capital plan and equipment asset management, and reliability. Manages capital appropriation approval for assigned projects and spending management. Leads cross functional teams that includes equipment, automation, and packaging engineers to deliver key projects driving business results in alignment with the site goals and objectives.

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

Requirements:

• Education: Bachelor of Science degree (or equivalent) in Engineering required. Chemical, Mechanical, Electrical or any other engineering discipline is required. Advanced degree preferred.
• Experience: 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.
• Knowledge, Skills, and Abilities: 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.
• Certifications/Licenses: Six Sigma Green Belt/Black certification preferred. Professional Engineer (PE) license is preferred. Project Management preferred.
• Leadership: Demonstrated solid competencies on the values and behaviors to effectively contribute to the transformation of the scope of work. Ability to work as a Team Player.

What's in it for you

Annual base salary for new hires in this position ranges:

$110,500.00 - $156,000.00

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

• Competitive Benefit Package*
• Paid Company Holidays, Paid Vacation, Volunteer Time & More!
• Learning & Development Opportunities
• Kenvuer Impact Networks
• This list could vary based on location/region

*Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.