Manager Engineer

Scott A. Edwards

Bethlehem, PA 484-***-**** cell 610-***-**** Home

******@*****.*** www.linkedin.com/in/scottaedwards/

PHARMACEUTICAL / MEDICAL DEVICE; OPERATIONS, QUALITY ENGINEERING, PACKAGING, VALIDATION & PROJECT MANAGER

A Results-Oriented / Strategic Manager, Project Planner and Engineer with proven leadership experience in Packaging, Quality, Validation / Qualification, Operations, Logistics, Project planning and Operational Excellence.

Core Competencies:

Packaging Transfers and Launches

Project Management

Lean Six Sigma (Green Belt Certified)

Operations, Packaging, Quality & General Management

GMP / CAPA / Change Control / Complaint Management

Positive Leadership / Team Focus

Substantial Experience in Packaging Environments of the medical device and pharmaceutical industries

Extensive Validation Experience related to Packaging, Packaging Sterilization and Assembly Equipment

Proven positive people skills focusing on internal and external customers

People, goal, process, time and quality oriented professional

Experience in Solid-Oral Dose, Blister Packs, Liquid Fill Packaging

Equipment Validation - Project management

Calibration Management

KPI’s / Metrics

Operations Logistics and Planning

Education / Coach

PROFESSIONAL EXPERIENCE

IMPAX LABS, Middlesex, NJ (Formerly CorePharma, LLC) – Site Closure 2014 – 2017

Senior Manager Pharmaceutical Technology (2016 – 2017)

Manager Equipment Qualification – Pharmaceutical Technology Services (2014 – 2016)

Managed engineers / consultants / projects for several successful packaging transfers (Oxymorphone, Fludrocortisone, Amphetamine Salts, Midodrine, Methyltestosterone, Pilocarpine HCl, Deoxycycline, Rimantadine HCl, Colesevelam HCl, Morphine Sulfate ER, Sevelamer Carbonate IR, Ezetimibe/Simvastatin, Carvedilol Phosphate ER, Terbutaline Sulfate) to Middlesex site and also packaging tech transfers (Oxycodone, Molindone, Felbamate, Phenyltonin) from onsite manufacturing for product launches (NPL).

Reviewed / Approved all packaging specifications, BOM’s and packaging batch records.

Managed engineers responsible for equipment qualification / validation for manufacturing and packaging equipment.

Project Manager for all Packaging Validations for product transfers (Developed Validation Plans). Part of Packaging (Optel) Serialization team – NJM Labelers.

REXAM-HEALTHCARE, Washington, NJ (Purchased by Berry Plastics Corporation) 2012 – 2014

Plant Quality Manager

Managed Compliance, Customer complaints, Supplier quality, Quality Inspectors, Specification Reviews, Change Controls, Deviations, Customer Audits, Validation, and Continuous Improvement associated with Injection Blow Molding (Jomar) of Pharmaceutical bottles. Bench marked/Monitored Quality KPI’s. Maintain ISO: 9001/2008.

PIRAMAL CRITICAL CARE, Bethlehem, PA 2010 – 2012

Packaging Manager

Managed the bottle filling and packaging operations of inhalation anesthetics. Improve output and efficiency of operation on existing antiquated packaging equipment.

SCHERING PLOUGH / MERCK, Allentown, PA (Formerly ORGANON, INC. – Site Closed) 2001 – 2010

Manager Technical Support

Led / managed project activities to support packaging development and packaging demand requirements. Managed all validation related projects from design conception through the completion of validation studies (transfer to production) in support of new equipment and/or product launches.

Served as the Allentown Project leader, in conjunction with the Overall Asenapine Project Leader (Ireland) for the acquisition of Asenapine (Saphris) shellpack packaging equipment from Germany.

Served as Project leader, spearheading a cross-departmental NPT Allentown Team that successfully assured the preparation for the introduction and launch of Implanon, including assuring equipment was successfully qualified and ready for PAI audit.

Coordinated work to acquire a BMS High Speed bottling line. Project leader who managed contractors in the successful re-installation, integration of high speed bottling line for introduction of Livial in the USA.

Managed Calibration Program, Validation/Packaging Engineers, Consultants and Facility Personnel.

ADDITIONAL RELEVANT EXPERIENCE

SCHERING PLOUGH / MERCK, Allentown, PA

Associate Manager Technical Support and Validation Engineer

Led / managed project activities to support packaging development and packaging demand requirements.

Managed all validation related projects from design conception through the completion of validation studies (transfer to production) in support of new equipment and/or product launches.

B. BRAUN MEDICAL INC. (Allentown, PA)

Sterilization Manager, Quality Engineer, Production Supervisor / Packaging & Assembly

Specializing in ETO Sterilization Operations, Operations Management, Coordinated all Ocean/Air Incoming Freight, Logistics, CAPA, Defect / Trend Analysis, Customer Complaints Root Cause Assessments, Shipping/Packaging Sterility Validation, Equipment Validation, Approved medical device assembly designs and packaging specifications (Design Controls).

TEXTRON LYCOMING (Stratford, CT),

Resource Analyst II – Source Planning

Analyzed impact / provided visibility for all changes to forecast loadings or master delivery schedule.

KENSTON BOARD OF EDUCATION, Chagrin Falls, OH

Kenston High School Biology and Physical Science Teacher

HS Wrestling (Several winning and Championship Seasons), Assistant Football, Softball and Soccer Coach.

EDUCATION

Bachelor of Science Degree in Mechanical Engineering, University of Connecticut, Storrs, CT

Bachelor of Science Degree in Secondary Education, University of Clarion, Clarion, PA

(Double Major: Biology and Physical Science) (Recruited College Wrestler)

PROFESSIONAL DEVELOPMENT

FDA Compliance Training

21 CFR Training Program (CSSC Inc.)

Lean / Sigma Workshop (ASQ)

Green Belt Certification – Lean-Six Sigma

Risk Analysis and Risk Management (PTi)

Managing Multiple Project, Objectives and Deadlines

Implementing Key Requirements for Validation (PTi)

Leadership Skills Training (Right Management Consultants)

GMP Compliance – Packaging and Labeling (J. Lee -PCA)

Pragmatic Calibration (Lighthouse Training Group)

Lean-Six Sigma – Yellow Belt Training & Lean-Six Sigma, Black Belt Training & Mini-Tab Statistical Software Training (MRC & Jim Athon, The Athon Group)

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