Senior Specialist Packaging Component Engineer

Biopharma Careers; Kansas; On-site; USD 106,000 - 167,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k)

Paid holidays

Job summary

Biopharma Careers seeks a Senior Packaging Component Engineer for our Wilson site to drive component lifecycle management and QA investigations. You will partner with suppliers, support product introductions, and influence global packaging programs.

The role requires a BS/MS in engineering with 4–5 years in packaging or process design, strong project management, and experience in GMP environments and design control.

Qualifications

• Requires a Bachelor of Science in engineering or MS with 4–5 years in packaging operations or process design.
• GMP environment experience and project management skills are essential.
• Knowledge of design control, verification, and validation for medical devices and combination products.

Responsibilities

• Author and revise specifications for components with cross-functional teams.
• Collaborate with vendors to develop and test components for qualifications and product launches.
• Lead change ownership and manage site-wide component-related changes.
• Support design transfer processes with packaging commercialization and device development teams.

Skills

Change Control

Project Management

Problem-Solving

Analytical Thinking

Continuous Improvement

Packaging Engineering

Packaging Operations

Documentation

Design Inputs

Root Cause Analysis

Deviations

Quality Assurance

Education

Bachelor of Science in Engineering

Master of Science in Engineering

Tools

GLAMS

Job description

Job Description

We have an exciting opportunity for a Senior Packaging Component Engineer at our Wilson site. This role is pivotal in supporting packaging and component engineering capabilities, focusing on effective component life cycle management, quality investigations, line projects, and continuous improvement initiatives. Join our team and contribute to the introduction of new products, network transfers, and processes, while collaborating with external suppliers and global support functions.

This position will report to the Associate Director of Packaging (Component Engineering) and will have frequent interaction with other business units at the site as well as external suppliers, packaging commercialization, device development and technology, and global support functions. The team will also support other engineering activities at the site as well as quality risk management.

Off-shift support may be required due to business critical needs.

Responsibilities

• Author new and revise specifications for components with cross-functional teams to maintain consistent performance.
• Work with component vendors to develop and test components to support equipment qualifications, stability, distribution studies, and product launches for various global markets.
• Assist with design transfer processes from packaging commercialization and device development teams, partnering with the Packaging Technical Operations team for upcoming changes and strategic initiatives.
• Act as Change Owner/Project Manager for component-related changes and SME for impact assessments/tasks on all site changes for assigned areas.
• Initiate and maintain workflows in GLAMS (Global Artwork Management System) for printed component structural drawings for usage by Print Coordinators and global markets in product artwork development.
• Troubleshoot line issues potentially related to component performance, including potential weekend and off-shift work; initiate and manage events in the supplier Incident Management System (IMS) for supplier investigations.
• Provide technical support to set and improve run standards based on component capability and variability.
• Partner with Procurement and Supplier Management teams for supplier performance monitoring, technical assessments, and new vendor introductions.
• Facilitate machine trials and provide technical assessments for packaging component introduction and changes throughout the product lifecycle.
• Provide technical SME support for component-related deviations and customer field complaints.
• Author quality event investigations for site component-related deviations to prevent recurrence, including determination of event scope, impact assessments, root cause analysis, identifying corrective/preventative actions, and remediation steps/final dispositions.
• Support regulatory inspections and audits, providing engineering support to packaging operations to ensure technical site readiness and address regulatory agency observations.
• Participate in Design Requirements Specifications, Design Reviews, Review of Purchase Specs, and Functional Specs.
• Participate in FATs and execution of IQ/OQ/PQ with a focus on component interaction and packaging system integrity.
• Support quality risk management assessments related to packaging operations and components.

Qualifications

Required

• Bachelor of Science (B.S.) degree in engineering or equivalent and a minimum of five (5) years of experience in packaging operations, pharmaceutical unit operations, or process design OR Master of Science (M.S.) degree in engineering or equivalent and a minimum of four (4) years of experience in packaging operations, pharmaceutical unit operations, or process design.
• Comprehensive background in packaging process and components.
• Experience working in a GMP environment.
• Project management skills and experience implementing projects.
• Effective analytical and decision-making ability.
• Knowledge of formal problem-solving techniques such as root cause analysis and/or Lean Six Sigma.
• Technical writing and document review experience (deviations, change requests, standard operating procedures, protocols, etc.).
• Knowledge of Medical Device and Combination Product requirements, including design control, verification, and validation.

Required Skills

Change Control Processes, Change Control Processes, Coaching Managers, Competency Management, Design Inputs, Detail-Oriented, Deviation Management, Driving Continuous Improvement, Engineering Specifications, Engineering Standards, Engineering Support, Equipment Designing, Equipment Engineering, Innovation, Life Cycle Planning, Manufacturing Process Improvements, Materials Science, Package Testing, Packaging Engineering, Packaging Equipment, Packaging Innovation, Packaging Operations, Packaging Processes, Procedure Writing, Product Packaging Design {+ 8 more}

EEO/DEI Statements

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is $106,200.00 - $167,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Employee Status: Regular

Relocation: Domestic

VISA Sponsorship: No

Travel Requirements: 10%

Flexible Work Arrangements: Not Applicable

Shift: 1st - Day

Valid Driving License: No

Hazardous Material(s): n/a

Job Posting End Date: 09/19/2026

Requisition ID:R414465