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<pre>Array ( [var] => cut_url ) </pre> Resume for Bharat A. for Manufacturing / Factory Worker / Biotechnology & Pharmaceuticals in Englewood, Colorado. Search More Resumes for Manufacturing / Factory Worker on Resumark.com #8FSO1763I
 

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Resume for Bharat A. for Manufacturing / Factory Worker / Biotechnology & Pharmaceuticals in Englewood, Colorado




Occupation: Manufacturing / Factory Worker Industry: Biotechnology & Pharmaceuticals
Country: United States City: Englewood
State: Colorado ZIP: 80110



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OBJECTIVE: 

To obtain a senior level packaging, validation, technology transfer or manufacturing position in the pharmaceutical, medical device or consumer products industry. 

SUMMARY: 

  • MS in Materials Science & Packaging Engineering and BS in Pharmacy with over years of professional experience in pharmaceuticals, medical devices and consumer products
  • years packaging validation, PAI Readiness and Technology Transfer experience of Oral Solid Dosages, Injectables, Liquids, Ointments & Creams of pharmaceuticals & medical devices in USA, Europe and Asia
  • years packaging development experience of medical devices, pharmaceuticals and consumer products
  • years production operations, marketing and sales experience of pharmaceuticals and consumer products
  • Subject Matter Expert SME responsible for the coordination & approval of all packaging validation functions of existing & new Technology Transfer products for FDA & NonFDA regulated Global Finishing Sites at Schering Plough Corporation in USA, Europe and Asia to include PAI Readiness & Validation
  • Developed Packaging Validation related guidance documents, training programs and templates at Schering Plough Corporation for finishing sites in USA, Europe and Asia
  • Consulted for numerous pharmaceutical Fortune companies in the capacity of a GMP auditor, packaging development engineer and validation specialist for Oral Solid Dosages, Injectables, Liquids, Ointments and Creams
  • Project Manager responsible for the development and validation of PETG and PS blisters for Medical Devices at Becton Dickinson Infusion Therapy
  • Validated packaging presentations for Ethylene Oxide sterilized and Cobalt irradiated needles, sutures and medical devices for Ethicon, Inc. and consumer products for American Cyanamid and IC Industries
  • Excellent team player;  Work well with management, finishing sites personnel and vendors
  • Willing to travel extensively as required
  •  

    PROFESSIONAL EXPERIENCE: 

     Baxa Corporation, Englewood, CO

    Packaging Engineering Manager – Process Excellence 

    Packaging Engineering Manager responsible for the initiation & startup of packaging development & validation program.  Developed new packaging, specifications & templates for new product development of Hazardous Drug Handling HDH & existing medical devices; Reviewed & approved validation protocols; Approved current vendors; Identified & Sourced new vendors for sterile, medical device packaging. 

  • Responsible for the development of all packaging related SOPs, guidance documents & training programs for sterile & nonsterile medical devices.
  • Active member of Quality Systems Regulations teams, being an alternate leader on the Process Validation Team.  Our responsibility was to ensure that all Quality Manuals SOPs were appropriately updated per FDA Regulations & met requirements of FDA Observations.
  • Identified, interviewed & hired consultants to assist Baxa Corporation in updating Quality Manuals to meet FDA Observations. 
  •  Schering Plough Corporation, Kenilworth, NJ

          Technical Manager – Global Technical Services 

    Subject Matter Expert SME in the Global Validation & Process Management Technical Services Department, responsible for assisting pharmaceutical finishing sites by developing, reviewing, commenting and concurring upon all solid dosage and secondary packaging validation strategies, ranging studies and validation protocols and completion reports for all FDA and NonFDA regulated Global Finishing Sites in preparation for PAI Readiness, Technology Transfers and Validation. 

  • During the consent decree, as an SME, I single handedly managed over – Technology Transfer and Global initiative projects annually.  All project deadlines were met ahead of scheduled time lines.  Thereby, all consent decree initiatives were met as scheduled and Schering Plough did not pay any fines.  My contributions were appropriately recognized by corporate management.
  • Projects included but were not limited to the validation of existing and new packaging processes of solid dosage forms into bottles, conventional and cold formed thermoformed blister presentations and all secondary packaging.  The Technology Transfer encompassed transfer and validation of existing drug products from sitetosite and new drug products to US and international finishing sites including Puerto Rico, Belgium, Canada, Japan and Singapore.
  • Developed a training program for high level Packaging Validation SOP, a Guidance Document for Packaging Validation Protocols & a corresponding Packaging Validation Protocol Template.  These documents assisted over + sites develop consistency & uniformity in the packaging validation process.
  • Spearheaded monthly Packaging Validation Tactical Ring Teleconferences and highly successful annual FacetoFace Packaging Validation Tactical Ring Meetings attended by International Finishing Sites, Global Supply Chain and Research Institute representatives.  These meetings developed transparency between sites and corporate departments and facilitated uniformity in packaging validations internationally.
  •  

     BSA Consulting Technologies, East Brunswick, NJ

          Consultant 

    Clients served: Johnson & Johnson, Warner Lambert; BristolMyers Squibb Company; Lockwood Greene; RhonePoulenc; Fresenius Medical Care; etc. 

  • As Project Leader, supervised validation engineers to ensure adherence to an aggressive validation schedule set forth by the client. Project encompassed validation of a new facility and equipment for solid dosage products.
  • Supervised and reviewed protocols to validate renovations of sterile filling rooms of a multinational corporation.
  • Developed & tested Primary, Secondary & Tertiary ' Second Generation ' packaging for Solids; liquids & aerosols.
  • Developed Packaging Component Specifications and Standards; SOPs and BOMs; Interfaced with Subcontractors, ensured smooth and timely launch of new pharmaceuticals including Class II Drugs; Audited for GMP and FDA Compliance.
  • For dialysis fluids manufacturer, incorporated continuous cost savings & increased production outputs by reducing RO / DI water flushing of bulk blending / packaging tanks by more than %, preserving over , gallons of unproductively exhausted RO / DI water daily. In addition, local municipal authorities commended manufacturer for reducing chemical waste disposal in sewers; Audited documents for compliance.
  • Tested and approved packaging components and participated in the establishment of formal documentation procedure to expedite traceability of critical packaging components for international pharmaceutical company.
  •  

     American Pioneer Electronics, Inc., East Brunswick, NJ

          Global Marketing, Sales and Purchasing Manager 

  • Handson Manager of Marketing, Sales and Purchasing for electronic components and integrated circuits; increased overseas and domestic sales significantly.
  •  

     Becton Dickinson Infusion Therapy, New Providence, NJ

          Package Development Project Manager 

  • Project Manager responsible for the development and testing of unique PETG and PS blisters for second and third generation Central Venous Catheters.
  • Developed SOPs and BOMs, specifications and graphics of packaging components for Central Venous and Pulmonary Arterial catheters manufactured in Singapore and UK.
  • Identified, tested and approved new thermoformable plastic – PCTG; Designed and Developed new tray for Pulmonary Arterial catheters.
  • Qualified new blister manufacturer in Singapore. Redesigned existing blister and developed ship testing procedure; Audited documents for GMP and FDA Compliance.
  • Served as special assignee to Quality Director in Singapore compiled validation documentation to meet FDA and transit test requirements and gap analysis report.
  • Rationalized TYVEK® bags to bags and developed ship testing procedure.
  •  

     Johnson & Johnson Ethicon, Inc., Somerville, NJ

          Technical Services Engineer 

  • Technical Services Engineer responsible for validating and troubleshooting packaging processes, materials and equipment for $+ million division manufacturing Ethylene Oxide sterilized and Cobalt irradiated surgical products and medical devices.
  • Developed, transportation tested and validated form / fill / seal process for TYVEK® and overwrap packages resulting in zero nonconformances due to seal related defects, thereby reducing customer complaints significantly.
  • Received special commendation from Vice President of Operations for eliminating ozone depleting chemicals usage by % in the first year, substantially exceeding targeted goal of %; Audited documents for GMP and FDA Compliance.
  • Designed, transportation tested and validated several package configurations resulting in increased product efficacy; reduced cycle times and operating expenses by %.
  • Project leader on multiple domestic and international task force teams that substantially reduced launch times of new product introductions and process transfers.
  •  

     Schering Plough Corporation, Kenilworth, NJ

          Production Operations Supervisor 

  • As Supervisor of Production Operations, consistently maintained production efficiencies at % of set standards; Audited documents for GMP and FDA Compliance.
  • Reduced operating costs by $,. by leading and participating in Profit Improvement Programs, Work Quality Circles and Employees' Suggestion Plan.
  • Successfully orchestrated union avoidance campaign in department.
  •  

     IC Industries, Inc.:  Signal Stat Division, Somerset, NJ

          Packaging Development Engineer 

  • Initiated, restructured & consolidated packaging of heavyduty truck hardware, lighting and safety devices for OEM and aftermarket consumers; Developed SOPs and BOMs; Audited documents for compliance.
  • Designed and transportation tested unique corrugated package for emergency light bar that increased production %.
  • Converted WCCNB cartons to mist gray chipboard cartons; rationalized packaging components to realize annual cost savings in excess of $,..
  • Introduced inhouse Skin Packaging Program that reduced costs and improved control over the operation.
  •  

     American Cyanamid, Wayne, NJ

          Packaging Development Engineer 

  • As Packaging Engineer, developed cosmetic packages from initial concept to point of sale; sourced domestic and international vendors; Audited documents for compliance.
  • Authored packaging specifications, SOPs and Bills of Materials.
  • Frequently interfaced with suppliers, purchasing, marketing, manufacturing and R & D groups.
  • Developed and implemented cost reduction program for cosmetic packages that realized savings in exceeding $,. annually.
  • Introduced inhouse Film Wrapping Project that reduced costs and improved delivery time to customers.
  •  

     Forest Laboratories, Far Rockaway, NY

          Production Operations Supervisor 

  • As Supervisor of Production Operations in the raw materials department of controlled & prescription pharmaceuticals & OTC vitamins & mineral supplements, efficiencies & outputs of the department were increased % by streamlining the weighing operations of APIs & supplemental pharmaceutical ingredients.
  •  

    EDUCATION: 

    Rutgers University MS Materials Science and Packaging Engineering; Research Fellow 

    Bombay University BS Pharmacy 

    AWARDS: 

     Schering Plough Corporation Distinguished Contributors Award presented by CEO and Board of Directors for successfully completing all Consent Decree assignments as scheduled 

     Schering Plough Corporation Appreciation Award presented by CEO and Board of Directors for successfully completing the Technology Transfer of Ezetimibe tablets from Puerto Rico to Singapore 

    MEMBERSHIPS: 

     Honored Member:  Emerald Who’s Who for Executives and Professionals 

      Life Member:  American Association of Indian Pharmaceutical Scientists AAiPS


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