Staff Engineer, Packaging Equipment

Kenvue•Fort Washington, PA

1d•$110,500 - $156,000•Onsite

About The Position

The Staff Engineer, Packaging Equipment provides technical support for the specification, development, implementation, and assurance of qualified packaging equipment. The role aligns equipment requirements with site needs and customer service, quality, and compliance goals. It is accountable for project capital planning, equipment asset management and reliability, capital appropriation approvals, and spending management. The engineer leads cross-functional teams, including equipment, automation, and packaging engineers, to deliver projects that advance business and site objectives. The position plans and executes equipment and validation projects, develops risk mitigation strategies, and improves processes and equipment technologies across locations. It leads equipment installation, qualification, validation, and start-up, provides technical solutions and troubleshooting, and supports operations and packaging teams. The role also develops and reviews qualification and validation documentation, manages change controls and investigations, and drives compliance, quality, efficiency, cost, and sustainability improvements. The Staff Engineer independently manages complex projects from concept through post-implementation, provides technical direction to external resources, and may mentor co-ops and entry-level engineers. The role is fully onsite in Fort Washington, Pennsylvania, and reports to the Sr Manager, Engineering & Automation.

Requirements

Bachelor of Science degree or equivalent in Engineering; Chemical, Mechanical, Electrical, or another engineering discipline.
At least 6 years of experience.
Relevant experience in engineering, packaging, technical, and/or operations work.
Knowledge of current Good Manufacturing Practices (cGMP) and Good Documentation Practices.
Bilingual in English and Spanish.
Excellent verbal, written, and technical writing skills.
In-depth understanding of cGMP and FDA regulations.
Awareness of quality assurance methodologies, risk management, and compliance auditing.
Strong knowledge of manufacturing processes, including packaging equipment, utilities, and automation systems.
Proficiency in Microsoft Office Suite, including Excel, Word, and PowerPoint.
Experience with equipment installation, troubleshooting, commissioning, qualification, and validation.
Basic knowledge of client/server architecture, network connectivity, and IT infrastructure in regulated environments.
Project management and time management skills, including prioritization under pressure.
Ability to communicate effectively with technical and non-technical personnel and audiences.
Ability to lead cross-functional teams and drive continuous improvement initiatives.
Ability to make sound decisions based on data and regulatory requirements.
Ability to work independently with minimal supervision in a fast-paced environment; takes initiative and exercises good judgment in problem-solving and operational execution.
Demonstrated leadership competencies aligned with company values and behaviors, and ability to work as a team player.

Nice To Haves

Advanced degree.
Experience with a pharmaceutical or consumer products company.
Experience working in an FDA/cGMP compliance environment.
Six Sigma Green Belt or Black Belt certification.
Professional Engineer (PE) license.
Project Management certification or qualification.

Responsibilities

Plan and execute multiple or major equipment and validation projects related to life-cycle management, and develop risk mitigation strategies to meet project commitments.
Understand and improve processes and equipment technologies across multiple locations, benchmarking sites to identify best-in-class processes.
Plan and execute equipment and validation strategies aligned with consumer asset management strategies; identify limitations and develop technical solutions to eliminate waste.
Lead equipment installation, qualification, validation, and start-up, communicating potential issues and providing direction to site teams.
Provide engineering solutions, technical advice, and assistance to Operations, Packaging, and other departments.
Develop and execute equipment plans to maintain high Operational Equipment Efficiency (OEE), and lead multi-site improvements in compliance, quality, efficiency, and cost.
For packaging assignments, support or lead the development and assessment of design requirements, change scope, packaging and equipment solution proposals, knowledge and gap assessments, risk assessments, test plans, and test results analysis.
Develop, write, and obtain cross-functional alignment on documentation for equipment system qualifications and validations.
Support or lead line trials, engineering studies, equipment qualification, and process performance qualification.
Ensure required training is current and completed before specific work activities, including training for direct reports where applicable.
Support or lead development, execution, and review of change controls for equipment and validation-related changes.
Provide technical support or lead equipment and process troubleshooting and improvements; use root-cause tools such as Kepner Tregoe and DMAIC, and write or approve technical memos, non-conformance reports, and CAPAs as required.
Prepare or approve Equipment Periodic Reviews and write or approve SOPs within area of experience and training; provide technical advice on SOPs, policies, and procedures.
Manage investigations, CAPAs, and annual product review (APR) data collection, analysis, and review or approval.
Review and approve commissioning and qualification documentation, including plans, protocols, and reports, as required.
Assist with review and approval of computer system validation documentation as required.
Review and approve package validation documentation, including protocols and reports, as required.
Use project management tools and independently manage complex projects from concept through post-implementation; solve problems independently.
Provide technical direction to external resources such as designers, suppliers, contractors, and consultants.
Serve as a technical subject matter expert on changes, improvements, continuous improvement projects, and sustainability.
Lead a technical team or serve as primary technical lead for cross-functional teams, coordinating project activities and resources.
May provide direction and mentorship to co-ops and entry-level engineers.
Influence people and manage multiple projects and tasks of varying complexity; resolve difficult technical issues with substantial effects on product quality and business outcomes.
Maintain proficiency in required cGMP, SOP, testing procedure, and data-analysis training.