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Winchester

    Packaging Engineer - Winchester, United States - Kymanox

    Kymanox
    Kymanox Winchester, United States

    3 weeks ago

    Default job background
    Freelance
    Description


    Is Kymanox the right fit for you?

    You want to make a difference and have an impact...

    You enjoy having an influence in your day to day work...

    You are motivated by working alongside a team filled with subject matter experts that will help you learn and grow...

    You wake up every day and do what you do

    ... because patients deserve better.

    If this sounds like you, you've come to the right place.

    Job Description:

    The Primary Packaging Engineer will work with cross functional teams to develop, test, validate, and commercialize pharmaceutical & device package solutions for both new and existing products. He/she will support continuous improvements as well as problem resolution and redesign when required for marketed products. The candidate will work in compliance with relevant industry standards as well as customer guidelines (standards) and be responsible for:

    •Developing, reviewing, and approving the following packaging documents: packaging component specifications, packaging Bills of Materials, packaging component drawings, design history files (for combination products), risk/criticality assessments, and procedures for bulk and finished drug product.

    •Designing packaging systems for small and large molecule drug products including materials for primary, secondary, and tertiary packaging as well as equipment automation for those processes.

    •Leading or supporting primary packaging related regulatory filings.

    •Ownership of distribution testing, shipping studies, line trials, packaging material qualifications, child resistant requirements, human factor studies and patient centric designs.

    •Identification and validation of secondary and tertiary package materials and suppliers.

    •Leading and/or participating in harmonization/standardization, quality risk remediation/reduction, and continuous improvement projects that may span across several customers.

    •Partnering with customers' marketing groups to effectively support packaging and graphic requirements.

    •Partnering with customers' Regulatory Affairs & Global Graphics Services to effectively incorporate copy and legal content to package components.

    •Developing, tracking, and maintaining project plans and budgets for packaging related projects.

    •Originating and developing new packaging projects and initiatives that lead to process improvements & have a significant business impact.

    •Supporting sustainability / green packaging initiatives as required.

    Desired Aptitude and Skill Set:
    • Flexible and versatile
    • Highly organized
    • Resourceful
    • Strong project management skills
    • Self-directing, self-pacing, fast learner
    • Ability to lead and/or support multiple project teams simultaneously

    •Excellent written and oral English communication
    • Appreciation for variety
    • Pleasant and positive communication style
    • Strong customer-service aptitude
    • Excellent problem-solving skills
    • Seasoned soft skills (i.e., high EQ)
    • Team player
    • Thrive in a fast-paced, growing, and dynamic work environment
    • Technology savvy
    Educational Background:

    Bachelor of Science in Science-related discipline or Engineering from an accredited institution. Degree within Packaging is preferred.

    Experience:

    •Bachelor's degree with years of professional experience in pharmaceutical (sterile product manufacturing is preferred) or medical device industries.

    Experience developing primary container designs and specifications and supporting primary packaging related regulatory filings.
    • Strong leadership and project management skills with proven track record within Packaging and/or Engineering.
    • Experience working within New Drug Product Development is preferred.
    • Experience in Serialization and Track and Trace for pharmaceutical products.
    • Experience with graphics and labeling of packaging components.
    • Solid background in primary packaging components such as glass and plastic containers, rubber closures, seals, syringes.
    • Experience in writing, executing, reporting, and presenting packaging system evaluations.
    • Strong understanding of global regulations regarding packaging.
    • Knowledge of line trial, equipment qualification, and validation practices are required.
    • Knowledge of combination products, design controls, and ISTA standards and application to pharma & medical device products.
    • Proficiency utilizing MS Office Suite (Word, PowerPoint, Excel, etc.), AutoCAD, and TOPs/CAPE Pallet Patter programs are preferred.
    About Kymanox:

    Kymanox ('ki-mah-noks'), meaning Ideal Knowledge Transfer, advances life science innovation through insightful solutions and collaboration. We do this by accelerating the design and commercialization of modern medicines for our customers using integrated engineering, scientific, compliance, and project management solutions that are insightful, collaborative, and comprehensive.

    By building and supporting the development of modern medicines, Kymanox has proven, end-to-end solutions that are helping bring better Life Science Products to the market- and keep it there. We do all of this with heart and pridebecause patients deserve better.

    Kymanox, founded in 2004, serves clients from Fortune 100 companies to virtual start-up companies all across the globe. Headquartered in Research Triangle Park, NC, we have US offices in Boston and Philadelphia, and since 2022 have expanded to Germany, Switzerland, and Israel.

    Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.
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