Validation Engineers - Component Preparation, Processing-Pharma Manufacturing

Validation Engineers - Component Preparation, Processing-Pharma Manufacturing

11 Jun 2024
Ohio, Westchester, 45069 Westchester USA

Validation Engineers - Component Preparation, Processing-Pharma Manufacturing

Vacancy expired!

REFERRALS GREATLY APPRECIATED!

$65 w2 pay rate

Project Description:
Our Client is seeking strong contract validation professionals to assist in the execution of validation activities, focused primarily on protocols. These roles will work closely with Work Stream Leads and other project personnel to achieve these deliverables specific to the new line. The project consists of the following work streams, and each Engineer will be primarily dedicated to a specific work stream with flexibility to support the other work streams:
  • Formulation, consisting primarily of:
    • Tanks (Buffer Hold, Formulation, Formulation Hold)
    • Scales (Weigh, Cryovault)
    • Peristaltic Pumps
    • Environmental Chambers
    • Powered Lifts
  • Component Preparation and Processing, consisting primarily of:
    • ATEC Component Prep and Processing Equipment
    • Sterilizing Autoclave
    • Parts Washer
    • CIP/SIP
  • Filling, consisting primarily of the following:
    • Vial Washer
    • Depyrogenation Tunnel
    • Vial Liquid Filler and Stoppering
    • Vial Capper
    • Open Active RABS
    • Swing Conveyor and Wall Transfer Mousehole
    • SCADA and Batch Management
    • Particle Counters
  • Facilities/Utilities, consisting primarily of the following:
    • Air Handling Units
    • CIP
    • Clean Utilities tie-ins (e.g., Process Air, Instrument Air, WFI), Clean Steam
    • Rooms/Area Qualifications

Responsibilities:
  • Working closely with the CQV Senior Lead, Equipment Vendors, and Operation personnel, perform the Validation related to Formulation, Component Preparation and Processing, Vial Filling, and Facilities.
  • Execution of IQ/OQ protocols.
  • Participate in discrepancy generation and closure.
  • Participate in Report generation and closure.
  • Assist with generation of Validation deliverables such as traceability matrices, assessments, and other supporting documentation.

Required Skills:
  • Engineering or technical degree preferred
  • Minimum 2 years GxP experience in respective work stream area (Formulation/Component Prep/Processing/Filling/Facilities)
  • COVID/Vaccine project experience is a plus

If this is a good fit for you, and you will accept $65/hr w2 if you are offered this Role,

please E-MAIL your UPDATED resume as a word doc to: Steve @ AlphaConsulting.com

Job Details

  • ID
    JC15352115
  • State
  • City
  • Job type
    Contract
  • Salary
    Up to $65
  • Hiring Company
    Alpha Consulting Corp.
  • Date
    2021-06-10
  • Deadline
    2021-08-09
  • Category

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