Packaging Engineer @ Actalent

Job Title: Packaging EngineerJob DescriptionThis role focuses on evaluating and enhancing packaging-related Design History File (DHF) content to ensure alignment with applicable regulatory requirements and standards. You will establish a clear baseline of existing packaging documentation, identify compliance gaps, and develop a structured remediation plan that supports high-quality, compliant medical device packaging.

Responsibilities

• Review existing Design History File (DHF) documentation related to packaging design, materials selection, testing, labeling, and validation.
• Identify and document applicable standards and regulations, including ISO standards, ISO -1, ISO -2, 21 CFR Part 820, and EU MDR, as they relate to packaging.
• Assess the completeness, accuracy, and regulatory compliance of packaging documentation within the DHF.
• Identify gaps in packaging documentation, including design inputs and outputs, packaging validation, accelerated and real-time aging studies, and labeling requirements.
• Coordinate with Quality, Regulatory Affairs, Engineering, and project stakeholders to align on packaging requirements, expectations, and remediation priorities.
• Prepare a packaging-focused DHF Assessment Report summarizing findings and current-state compliance.
• Develop a detailed Packaging Gap Analysis Matrix that clearly outlines deficiencies and required actions.
• Create a Regulatory and Standards Alignment Summary that maps existing packaging documentation to applicable regulations and standards.
• Develop a comprehensive Packaging Remediation Plan with a clear timeline to address identified gaps and ensure ongoing compliance.
• Support and track remediation activities to ensure timely completion of documentation updates and validation activities.

Essential Skills

• Professional experience in packaging engineering, with exposure to packaging for regulated products such as medical devices.
• Hands-on experience working with Design History Files (DHF), including documentation review and maintenance.
• Knowledge of FDA Quality System Regulations, including 21 CFR Part 820, as they relate to packaging and documentation.
• Understanding of ISO-based packaging standards, including ISO, ISO -1, and ISO -2, and their application to packaging validation.
• Familiarity with EU Medical Device Regulation (EU MDR) requirements related to packaging and labeling.
• Experience with packaging validation activities, including test planning, execution, and documentation.
• Ability to assess and interpret accelerated and real-time aging studies for packaging systems.
• Strong skills in documentation analysis, gap assessment, and remediation planning within a regulated environment.
• Ability to collaborate effectively with cross-functional teams, including Quality, Regulatory Affairs, and Engineering.
• Bachelor's degree and 1+ year of relevant experience, or Associate's degree and 3+ years of relevant experience, or High School Diploma (or equivalent) and 5+ years of relevant experience.

Additional Skills & Qualifications

• Direct medical device packaging engineering experience, including design and validation of sterile or non-sterile packaging systems.
• Prior experience in DHF remediation projects, including structured documentation review and corrective action planning.
• Detailed knowledge of packaging validation requirements defined in ISO standards.
• Familiarity with labeling compliance requirements for medical devices under FDA and EU MDR frameworks.
• Experience conducting or interpreting packaging aging studies to support shelf-life claims.
• Proven ability to work within cross-functional project teams and align stakeholders on regulatory and quality expectations.
• Strong organizational skills with the ability to manage multiple documentation and remediation tasks simultaneously.
• Attention to detail and a methodical approach to documentation, traceability, and regulatory alignment.

Work EnvironmentThis role is based onsite in Warsaw. You will work in a professional office and technical documentation environment, collaborating closely with Quality, Regulatory, and Engineering teams. The position involves frequent interaction with design and validation documentation, regulatory references, and structured project tools to manage DHF assessments and remediation activities. Onsite presence supports close coordination with stakeholders and timely review of packaging documentation and project deliverables.

Job Type & LocationThis is a Contract position based out of Warsaw, IN.

Pay and BenefitsThe pay range for this position is $45.00 - $55.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

Medical, dental & vision

Critical Illness, Accident, and Hospital

401(k) Retirement Plan Pre-tax and Roth post-tax contributions available

Life Insurance (Voluntary Life & AD&D for the employee and dependents)

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

Time Off/Leave (PTO, Vacation or Sick Leave)

Application DeadlineThis position is anticipated to close on Nov 7, 2026.

Workplace TypeThis is a fully onsite position in Warsaw,IN.About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options.

San Francisco Fair Chance Ordinance

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI)

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.