Senior Packaging Engineer
2 days ago
THE COMPANY:
Formulated Solutions is redefining the Pharmaceutical and Self-Directed Consumer Healthcare CDMO experience through creativity and invention; delivering our world class Marketing Partners unmatched formulations, innovative packaging and cost effective, reliable supply.
Formulated Solutions is and shall always be a company of people with the knowledge and dedication to provide our Marketing Partners with a single source solution for delivering quality and innovative products to market. We shall embrace changes and new opportunities as a vehicle to continually develop and grow sustainable relationships. As a company we shall never accept anything less than a culture that fosters creativity, growth, and profitability for both our Partners and the company.
PRIMARY PURPOSE:
The Senior Packaging and Labelling Engineer serves as the lead packaging development, validation, and commercial resource for Formulated Solutions. Responsibilities include the design, development, specification, testing, and implementation of new or alternative packaging materials, components, assemblies, and structures from initial concept through production. The selected individual will troubleshoot, resolve, adjust, or redesign existing packaging as needed. They must have GMP and FDA experience.
MAJOR DUTIES AND RESPONSIBILITIES:
- Supports efforts on new customer concepts and existing product portfolio based on personal experience, market insights, competitive position, online research, technology, and market trends.
- Responsible for full packaging and labelling material scope from primary packaging through secondary and tertiary packaging materials.
- Develops Technical Specifications for Packaging, Artwork and Labelling, Inspection Records, etc.
- Develops new products to meet customer requirements per assigned projects.
- Prepares and submits Invention Disclosures to adequately capture new inventions and protectable IP.
- Works to proactively prioritize multiple projects and workload, effectively anticipating/managing resource gaps, and deliver to agree-to timelines.
- Develops new product ideas for presentation to Marketing for future consideration in customer innovation events.
- Prepares samples for customer evaluation or for use by other functions.
- Actively assists in troubleshooting packaging related issues.
- Coordinates testing and feasibility studies with internal and external testing labs and updates customers and management on results. Supports preparation of protocols for both formal and informal operational and stability testing.
- Develops working relationships with vendors and attends vendor meetings.
- Helps support the maintenance of packaging component supply.
- Actively improves manufacturing processes, efficiencies, cost effectiveness, and customer satisfaction, where applicable.
- Developing and executing standard operating procedures and guidelines for product packaging in the company
- Takes responsibility for the change controls and quality-related documentation that comes along with changes in packaging components or setting up new packaging components for the product(s) FS manufactures
- Other duties as assigned
QUALIFICATION:
Required
- 4-year college degree in packaging, engineering or equivalent.
- 10+ years of packaging engineering work in GMP and FDA regulated environment.
- Ability to independently generate protocols for package evaluation experiments.
- Advanced knowledge of various analytical equipment and techniques utilized in an analytical laboratory.
- Understanding of regulatory requirements related to packaging materials and design.
- Demonstrated ability to work both independently and in a team environment.
- Familiarity with production equipment and processing technologies.
- Proficient in Microsoft Office programs (Word, Excel, Outlook, CAD) and CRM software
- Travel up to 10%
Preferred Additional
- Aerosol package development experience
- Knowledge of EU and other global packaging requirements & standards.
- Regulated products package development
- Experience with packaging-related software.
CRITICAL SKILLS AND ABILITIES:
- Demonstrated Analytical and Problem-Solving Skills.
- Ability to elicit cooperation from a wide variety of sources, including upper management, customers, suppliers, board, and other departments.
- Excellent written and oral communication skills.
- Ability to lift up to 25 pounds.
- Ability to work in a dynamic environment with shift priorities.
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