Sr Packaging Engineer

DESCRIPTION

Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team!

POSITION PURPOSE

The PDI's R&D Engineering team thrive in developing new innovation, technology and design to meet our customers' need and differentiate our products by disrupting the infection prevention, control and device industry.

The Sr R&D Engineer plays a key role supporting new product development, existing product portfolio maintenance, cost savings initiatives, and product improvements. This individual will lead the design and development of packaging activities for FDA Regulated products and will execute on requirements to complete R&D analysis and documentation to ensure major milestones are met and product developments objectives are achieved.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

• Leads packaging development for FDA Regulated products

• Develops ideas, concepts and prototypes to solve problems and meet customer/consumer needs in new and superior ways

• Design innovative and differentiating packaging configuration

• Owns the packaging design SOPs for FDA regulated products

• Be the Subject Matter Expert for packaging standards related to drug and medical devices including but not limited to CCIT, ISO 11607, USP <1207>, USP <661>

• Champion the packaging design change control process for FDA regulated products

• Research packaging sustainability/innovation/trends for FDA regulated products and lead the implementation of those new innovative ideas

• Be responsible for projects packaging timelines and budgets

• Identifies technical and project risks and ensures strategies are in place to effectively mitigate risks

• Work in close collaboration with the packaging laboratory for testing needs

• Identifies key quality attributes for packaging components

• Write SOP, protocols and trial request to support the projects

• Works with plant associates to gain alignment to specifications

• Packaging testing subject matter expert

• Develops, writes and validates packaging design test methods for FDA regulated products to evaluate performance of prototypes and final packaging

• Able to troubleshoot with the laboratory equipment when necessary

• Provides guidance and direction to junior scientists and engineers

• Ensures their activity is aligned to project milestones

• Trains new hires on packaging design test methods and departmental SOPs for FDA regulated products

• Provide guidance and mentoring

PERFORMANCE MEASUREMENTS

• Meet deadlines and budgets identified by the project teams

• Deliver on new packaging innovations

• FDA Regulated products packaging design Subject Matter Expert in regard to standards, SOPs and Test Methods

QUALIFICATIONS

EDUCATION/CERTIFICATION

• BS Mechanical Engineer, Packaging or equivalent from an accredited program

REQUIRED KNOWLEDGE

• Technical knowledge of regulated packaging, e.g., flexible films, rigid containers/injection molding, cartons, and corrugated

• Subject Matter Expert in packaging design standards related to FDA Regulated products including but not limited to CCIT, ISO 11607, USP <1207>, USP <661>

• Knowledge of Packaging Engineering processes such as product life cycle, change, and an in-depth knowledge of cGMP packaging design and change management requirements

• Familiar with packaging production equipment

EXPERIENCE REQUIRED

• Five years plus relevant experience in packaging development; previous experience in wipes packaging advantageous

• Experience in developing and launching innovative packaging solutions in an FDA regulated environment; preferably pharmaceutical, medical device or consumer products

• Experience in mentoring, coaching, training junior associates

• Understanding of the product development and change control processes

• Experience in developing test method and test method validation

SKILLS/ABILITIES

• Strong analytical, organizational, decision making, written and verbal communication and presentation skills

• Excellent project management skills

• Be self- motivated and capable of strategic planning

• Demonstrated ability to lead technical teams; able to work in a fast-paced environment, with multiple projects of varying complexity

• Computer skills- MS Office, TOPS or Cape, Solidworks or Creo, AutoCAD, Adobe, and Minitab

• Proven results with building strong customer relationships, anticipating customer needs, and delivering customer-centric solutions

• Ensures accountability and consistently achieving results

• Capacity to work in a fast-paced environment, with multiple projects of varying complexity

• Is able to build partnerships and works collaboratively with others to meet shared objectives

• Makes sense of complex, high quantity, and sometimes contradictory information to effectively solve problems.

• Is able to plan and prioritize work to meet commitments aligned with organizational goals

WORKING CONDITIONS

• 80% office / 20% lab

BASE SALARY RANGE

• $90,000 - $105,000

BENEFITS

PDI is pleased to offer comprehensive and affordable benefits for our associates, which includes:

• Medical, behavioral & prescription drug coverage

• Health Savings Account (HSA)

• Dental

• Vision

• 401(k) savings plan with company match and profit sharing

• Basic and supplemental Life and AD&D insurance

• Flexible Spending Accounts (FSAs)

• Short & long-term disability

• Employee Assistance Program (EAP)

• Health Advocacy Program

PDI also offers many voluntary benefits such as: Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts.

At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including: sick & safe leave, vacation, company & floating holidays, paid parental leave, and depending on the position we also offer summer hours and flex place/flex time options.