Mario Vela

FAQ About Mario Vela

• What is Mario Vela's address?

  Mario Vela is located at
  Andover, Massachusetts, United States

• What is Mario Vela's job title?

  Mario Vela is a
  Mostly working as a Project / Packaging/ Manufacturing / Serialization / Biotechnology / CQV / QAV/ Validation Engineer in a wide variety of projects and applications. Particularly interested in Biotechnology Cell Harvesting, Processing equipment, Packaging, or any Manufacturing line expansions that might require the use of someone with strong exposure to Validation or Operations in the Pharmaceutical/ Biological/ Medical Device Industry. In addition, acting as a collaborator conducting CAPAs, Supplier & Co-Manufacturer Audits, Quality Systems Reviews, and SOPs development. Also specializing in Validation/ Commissioning/ Equipment Qualification for manufacturing, facilities, utilities, and also on Packaging equipment. Specialties: - Experience with Biotechnology process equipment (Bioreactors, SIP of tanks and skids, Incubators and Bio Safety cabinets. Performing Temperature Mapping, Issuing Change Controls, P&ID Redline and performing Walk downs of "As Built" Drawings. -Experience with Solid Dosage Manufacturing Operations: Lifting & Handling, Storage & Transfer, Dosing & Weighing, Blending & Mixing, Granulation & Coating. - Experience with the qualification and validation of the following equipment’s: PK Blender (Blending Process), Courtoy, Fette, Korsh and Manesty (Compression Process) and Ackley Brander. - Experience writing SOP’s, GAP assessment, Risk Assessment, Functional Requirements. - Experience in all aspects of systems testing, writing test plans, test scenarios and test cases; conducting system testing [regression, integration, and stress analysis] and expertise in Statistical Process Control (SPC). - Experience reviewing and evaluating System Life Cycle documentation, Computer Validation Protocols, and their applicable SOP’s. - Experience in Packaging Equipment Validation (Bottle Lines, Blister Lines, and semi-solid) - Recognized for ability to face challenges head-on and execute sound decisions in the face of adversity. - Experience with Optel Vision Serialization Systems ( Track & Trace, Bottle Tracker, Carton Tracker, Virtual Bundle and Line Master) Validation. - Working with EMPQs for manufacturing Suites, IOQ's and PQ's for Biotech manufacturing equipment. - FDA Regulations, ISO 13485, ISO 14971, and ISO 14644 ­ 1. Am Technical Solutions

• What industry does Mario Vela currently work in?

  Mario Vela currently works in the
  Am Technical Solutions

• What is Mario Vela's area of expertise?

  Mario Vela specializes in
  Mostly working as a Project / Packaging/ Manufacturing / Serialization / Biotechnology / CQV / QAV/ Validation Engineer in a wide variety of projects and applications. Particularly interested in Biotechnology Cell Harvesting, Processing equipment, Packaging, or any Manufacturing line expansions that might require the use of someone with strong exposure to Validation or Operations in the Pharmaceutical/ Biological/ Medical Device Industry. In addition, acting as a collaborator conducting CAPAs, Supplier & Co-Manufacturer Audits, Quality Systems Reviews, and SOPs development. Also specializing in Validation/ Commissioning/ Equipment Qualification for manufacturing, facilities, utilities, and also on Packaging equipment. Specialties: - Experience with Biotechnology process equipment (Bioreactors, SIP of tanks and skids, Incubators and Bio Safety cabinets. Performing Temperature Mapping, Issuing Change Controls, P&ID Redline and performing Walk downs of "As Built" Drawings. -Experience with Solid Dosage Manufacturing Operations: Lifting & Handling, Storage & Transfer, Dosing & Weighing, Blending & Mixing, Granulation & Coating. - Experience with the qualification and validation of the following equipment’s: PK Blender (Blending Process), Courtoy, Fette, Korsh and Manesty (Compression Process) and Ackley Brander. - Experience writing SOP’s, GAP assessment, Risk Assessment, Functional Requirements. - Experience in all aspects of systems testing, writing test plans, test scenarios and test cases; conducting system testing [regression, integration, and stress analysis] and expertise in Statistical Process Control (SPC). - Experience reviewing and evaluating System Life Cycle documentation, Computer Validation Protocols, and their applicable SOP’s. - Experience in Packaging Equipment Validation (Bottle Lines, Blister Lines, and semi-solid) - Recognized for ability to face challenges head-on and execute sound decisions in the face of adversity. - Experience with Optel Vision Serialization Systems ( Track & Trace, Bottle Tracker, Carton Tracker, Virtual Bundle and Line Master) Validation. - Working with EMPQs for manufacturing Suites, IOQ's and PQ's for Biotech manufacturing equipment. - FDA Regulations, ISO 13485, ISO 14971, and ISO 14644 ­ 1.

• Which languages does Mario Vela speak? 

  Mario Vela speaks the following languages:
  No languages available.

• Which industries has Mario Vela previously worked in?   

  Mario Vela has prior experience in the following industries:
  Dps Group Global , Sanofi Genzyme , Takeda Oncology , Baxter International , Nypro A Jabil , Patheon , Neolpharma , Luitpold Pharmaceuticals , Amgen , Mcneil Consumer Healthcare , Bausch Lomb , Neolpharma , Mcneil Consumer Healthcare , Smith And Nephew , Bristol Myers Squibb , Becton And Dickinson , Pfizer Vega Baja , Vantage Consulting , Wyeth Pharmaceuticals

• What is Mario Vela’s work experience?  

  Mario Vela has the following professional experience:
  Am Technical Solutions , Dps Group Global , Sanofi Genzyme , Takeda Oncology , Baxter International , Nypro A Jabil , Patheon , Neolpharma , Luitpold Pharmaceuticals , Amgen , Mcneil Consumer Healthcare , Bausch Lomb , Neolpharma , Mcneil Consumer Healthcare , Smith And Nephew , Bristol Myers Squibb , Becton And Dickinson , Pfizer Vega Baja , Vantage Consulting , Wyeth Pharmaceuticals .

• How can I find Mario Vela on LinkedIn?  

  You can view Mario Vela’s
  LinkedIn profile at LinkedIn URL.

• What are Mario Vela’s work email addresses?  

  Mario Vela’s work email addresses are
  [email protected] .

• What company does Mario Vela work for?  

  Mario Vela works at
  Am Technical Solutions