LYNDEE C. GRENIS

*** ***** ******** ******

Oceanside, California 92054

Cell: 951-***-**** Email: ac6rs1@r.postjobfree.com

SUMMARY

An accomplished and innovative MBA, Packaging Project R&D Professional with eight (8) years of hands on experience in Packaging Development with a proven track record. This includes new packaging, product launch, quality assurance, regulatory compliance and package testing. Also included is a comprehensive Packaging Development experience, combined with strong leadership and project management abilities. Skilled at managing and working on various packaging initiatives and projects, simultaneously, to ensure timely completion and cost efficiencies using project management phases. Develop and maintain SOPs and Work Instructions for department. Work with cross-functional team to determine acceptable parameters for testing to be executed on products. Experience working in and following GMP documentation, validation, qualification, and calibration. Quality guidelines and standard practices are followed for writing and storing of documents. Preparing reports and keeping records is a key for our department as results impact other parts of the business. Developed and performed internal audits on labs. Knowledge of CAPAs, quality systems, ISO, 21CRF, and DCR.

PROFESSIONAL EXPERIENCE

NETWORK PARTNERS, Oceanside, CA April 2018 to Present

Staff Packaging Engineer

Contract position to develop a cold chain repository and group to function as main source of contact. The repository would be built with current solutions used by the company. The cold chain team would be responsible for all projects that involve temperature control during shipment of a product.

ALLERGAN, Irvine, California May 2011 to March 2018

Packaging Engineer III

Strong leadership abilities collaborating with global cross-functional team members and outside suppliers on projects. Strong project management skills to manage work on multiple various projects to ensure timely completion. Technical lead and resource on primary, secondary and tertiary packaging projects for Allergan corporate initiatives. This includes working on pharmaceutical products, medical devices, and consumer related combination products. Prepare, review, and approve SOPs, protocols, reports, lab notebook entries, and other paperwork as necessary. Responsible for managing feasibility and validating packaging, according to ASTM, ISTA, ISO, and internal standards, to ensure product integrity and consumer appeal under varying shipping and display conditions. Additional responsibilities include leading prototyping, designing and developing new, cost reducing, and brand protection, commercial packaging systems according to varying requests and requirements. Lead projects as necessary to meet quality standards, production capabilities, marketing requests, regulatory requirements, and distribution capabilities. Review NDAs as needed. Responsible for requesting: DCR, supplies, leachable/extractable testing, stability testing (accelerated and real time aging), and any other technical data needed. Experience with various types of packaging which includes: glass vials, unit dose vials, multi-dose bottles (bottle, tip, and cap), thermoform trays with Tyvek, PET, or foil lid stock, cold chain, labels, cartons, corrugated shippers, shrink film, flow wrap.

Relevant Project Experience:

Continuous improvement – Developed and led a 5S continuous improvement project for Allergan’s packaging engineering laboratory. Researched 5S principles and applied them to Allergan’s laboratory operations.

Streamlined projects – Developed an intake form for new projects being requested.

Primary container projects – Supplier change on a syringe for a combination product. Material change on a tube for an ophthalmic product. Added a feature to a implant device to increase production efficiency. Primary container was no longer going to be supported at third party supplier so evaluated other capabilities.

Cost reduction projects - Evaluate, design, and validate smaller shipping containers that use less dry ice to ship samples and products. Evaluate digital printing on smaller batches of certain products. Evaluate pallet patterns to increase efficiency.

Brand protection projects - Evaluated and validated tamper evident labels to add to specified Allergan’s products. Assist security department on suspect products.

Sustainability projects – Developed a ‘milk run’ that can be used for deliveries within 50 miles of facility. This allows a larger shipping container to be re-used; instead of up to six smaller shipping containers once.

Cold Chain projects – Developed various cold chain solutions for various products. Evaluated various solutions through thermal chamber testing, live shipments, and transit testing.

Thermoformed trays and lids – Heat sealing process development and sterile barrier system validation projects for combination and medical devices, including Tyvek and film lid stock.

CAPA projects – Performed root cause failure analysis.

IRVINE SCIENTIFIC, Santa Ana, California February 2011 to March 2011

Quality Analysis/Quality Control

Responsible for organizing and filing assigned paperwork and raw materials. Preformed streaking of microbial cultures on agar plates and smearing cell colonies on a slide for gram staining.

FLAVOR INFUSION, Laguna Beach, California August 2009 to February 2011

Product Development

Prepared beverages by weighing, mixing, measuring, and packaging. Performed development work on new beverages or line-extensions, when necessary. Evaluated product packaging for shelf life. Input data as to ingredients, pricing, finalized formulas, and all other information into TechWizard. Prepared nutritional information and pricing for end user consumer customers when requested. Participated in quality and sensory evaluation of ingredients and products. Maintained cleanliness of lab.

RONPAK, Mira Loma, California November 2008 to March 2009

Quality Analysis/Quality Control

Shadowed the QA/QC Manager in the workplace, received on the job experience. Responsibilities included: evaluation and detailed documentation of the quality of Self-Open-Sacks (SOS) and other paper packaging, reviewing and filing all QA/QC technician’s daily reports. Evaluated the glue of packaging to ensure product was still functional. Helped train and manage other employees.

EDUCATION

August 2016: Master of Business Administration, Pepperdine University, Malibu, California,

June 2009: Bachelor of Science Food Science and Technology, California State Polytechnic University, Pomona, California,

Affiliations:

Project Management Institute, member since 2017.

Institute of Packaging Professionals, member since 2012.

Institute of Food Technologists, member since 2009.

Southern California Institute of Food Technologists, member since 2008.

Relevant Skills:

Proficient with drop tester, vibration table, compression tester, vacuum chamber, temperature/humidity chamber, torqo, chatillon, magna mike, smartscope, leak testers, pH meter, refractometer, HTST, homogenizer, autoclave, silverson, carbonator, instron, mocon, rub tester.

Fundamental of Packaging certificate of training.

Lean Six Sigma Greenbelt certificate of training.

Proficient with Microsoft Word, PowerPoint, Visio, Project, InfoPath, Adobe LiveCycle (Java), Excel, Smart Scribe, TechWizard, CORAL, SAP, ePRO, PaxPro, SpecRight, Docspace.

Proficient in both Mac and Windows environments.

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