Peniel Ortega, Pmp

Peniel Ortega, Pmp Email and Phone Number

Streamlining Compliance, Validation, OpEx, and FDA-Readiness for Pharma and Biotech and Med Device Teams | Certified Six Sigma Black Belt | PMP | Driving Excellence @ PharmAllies
Chapel Hill, NC, US
Peniel Ortega, Pmp's Location
Raleigh-Durham-Chapel Hill Area, United States, United States
Peniel Ortega, Pmp's Contact Details

Peniel Ortega, Pmp work email

Peniel Ortega, Pmp personal email

Peniel Ortega, Pmp phone numbers

About Peniel Ortega, Pmp

Passionate leader fostering excellence in life science consulting. As PharmAllies' Managing Director, I shape strategic visions, ensuring operational success. Certified Six Sigma Black Belt and PMP, I excel in enhancing performance with a focus on quality systems, compliance principles, and applications. Expertise extends to risk-based Commissioning, Qualification, Validation, CSV, decommissioning, and data integrity. An enthusiastic educator, I share insights through industry forums and teach graduate-level project management courses at Stevens Institute of Technology. Holds an MS in Engineering Management and a BS in Chemical Engineering from NJIT.• Change Management• Commissioning, Qualification, & Validation (CQV) • GMP Decommissioning• Strategic Planning and Execution• Lean Manufacturing• Toyota KATA Learner/Coach• Kaizen• Quality Risk Management• Team-building• Computer System Validation (CSV)• Project/Program and Portfolio Management

Peniel Ortega, Pmp's Current Company Details
PharmAllies

Pharmallies

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Streamlining Compliance, Validation, OpEx, and FDA-Readiness for Pharma and Biotech and Med Device Teams | Certified Six Sigma Black Belt | PMP | Driving Excellence
Chapel Hill, NC, US
Website:
pharmallies.com
Employees:
9
Peniel Ortega, Pmp Work Experience Details
  • Pharmallies
    Streamlining Compliance, Validation, Opex, And Fda-Readiness For Pharma And Biotech And Med Device Teams | Certified Six Sigma Black Belt | Pmp | Driving Excellence
    Pharmallies
    Chapel Hill, Nc, Us
    View
  • Pharmallies
    Managing Director
    Pharmallies 2014 - Present
    Kenilworth, New Jersey, Us
    View
  • Merck
    Associate Director, Engineering
    Merck Feb 2011 - Jul 2014
    Manage the Engineering Center of Excellence (COE) – including project engineering, process improvement, calibration, equipment qualification and lab support departments.
  • Merck
    Manager, Engineering
    Merck Oct 2010 - Feb 2011
    Responsible for completion of strategic milestones for the decommissioning and transfer of 16 primary and secondary packaging lines for LOC, OSD, DPI and Aerosol products to 5 locations.
  • Merck
    Sr. Project Engineer
    Merck Jun 2007 - Oct 2010
    Managed various engineering projects of major scope ($10M Capital Budget) from initial evaluation to completion (end-to-end), ensuring, scope, timeline, cost, and quality output standards were achieved.
  • Merck
    Staff Equipment Validation Engineer
    Merck Feb 2005 - Jun 2007
    Managed the validation of equipment, facility, and utilities meetings FDA, EMA and corporate guidelines.
  • Stevens Institute Of Technology
    Adjunct Professor -Project Management
    Stevens Institute Of Technology 2008 - 2010
    Hoboken, Nj, Us
    • Responsible for design, development, and delivery of graduate level project management course • Designs learning measurements and program evaluation strategies to maintain program focus
    View
  • Stelex
    Project Manager/Sr. Consultant
    Stelex 2000 - 2005
    Project Manager for Stelex’s Process Validation and Equipment Qualification department; provided regulatory compliance, process improvement project resource and cost management solutions to the pharma, biotech, and medical device industries. Projects included work performed at the following sites:• J&J -Orthobiologic (PSGA), Raritan, NJ• Norman Noble, Inc, Highland Heights, OH• Alpharma, Inc., Baltimore, MD • Hosokawa, Summit, NJ • US Catton, Lachine, QC, Canada• Merck & Company, Inc., Rahway NJ• Schering Plough, Corp., Kenilworth, NJ, Manati, PR and Las Piedras, PR

Peniel Ortega, Pmp Skills

Change Control Computer System Validation Validation Fda Gmp 21 Cfr Part 11 Pharmaceutical Industry Cleaning Validation Capa V&v Quality System Technology Transfer Quality Assurance Gxp Process Simulation Sop Biotechnology Gamp Quality Control Aseptic Processing Regulatory Affairs Biopharmaceuticals Iso 13485 Glp Medical Devices R&d Root Cause Analysis Quality Auditing Regulatory Requirements Standard Operating Procedure U.s. Food And Drug Administration Decommissioning Verification And Validation Corrective And Preventive Action Good Laboratory Practice

Peniel Ortega, Pmp Education Details

  • The Tuck School Of Business At Dartmouth
    The Tuck School Of Business At Dartmouth
    Building A Successful Small Business
  • New Jersey Institute Of Technology
    New Jersey Institute Of Technology
    Engineering Management
  • New Jersey Institute Of Technology
    New Jersey Institute Of Technology
    Chemical Engineering

Frequently Asked Questions about Peniel Ortega, Pmp

What company does Peniel Ortega, Pmp work for?

Peniel Ortega, Pmp works for Pharmallies

What is Peniel Ortega, Pmp's role at the current company?

Peniel Ortega, Pmp's current role is Streamlining Compliance, Validation, OpEx, and FDA-Readiness for Pharma and Biotech and Med Device Teams | Certified Six Sigma Black Belt | PMP | Driving Excellence.

What is Peniel Ortega, Pmp's email address?

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What schools did Peniel Ortega, Pmp attend?

Peniel Ortega, Pmp attended The Tuck School Of Business At Dartmouth, New Jersey Institute Of Technology, New Jersey Institute Of Technology.

What skills is Peniel Ortega, Pmp known for?

Peniel Ortega, Pmp has skills like Change Control, Computer System Validation, Validation, Fda, Gmp, 21 Cfr Part 11, Pharmaceutical Industry, Cleaning Validation, Capa, V&v, Quality System, Technology Transfer.

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