Equipment Validation Specialist

$62000 - $72000 per annum
  1. Permanent
Walkersville, Maryland
  1. Technical Operations, Engineering, Process Engineer
Posted:21/04/2021
BBBH16384

Hobson Prior are seeking an Equipment Validation Specialist to join a world-wide biotech organisation on a permanent basis in US.

Please note that to be considered for this role you must have the right to work in this location.

Job Responsibilities
:

  • Determine discrepancies on the basis of risks involved. Identify the impact to validation including other functional areas as well as the impact to product and recognise further qualification needs.
  • Correctly evaluate the impact of a study's acceptance criteria and with input from supervisor / manager as required.
  • Contributes in contamination investigations and process failure investigations.
  • You will evaluate policies or procedures for compliance with regulatory guidance.
  • You will assess all change controls with an precise understanding
  • To review and approve deviations and validation protocol final reports
  • Experienced with regulatory guidance's applicable to equipment / cleaning validation, computer systems validation and process validation.
  • You will modify Templates as required.
  • You will author URS's and provide guidance and recommendations on an engineering project.
  • Responsible for the writing of and the implementation of project and system qualifications, validations, re-qualifications and revalidation of manufacturing facilities, equipment, utilities and processes.
  • Train and manage junior level specialists.
  • Discuss validation policies and philosophies during customer audits or regulatory inspections.
  • You will finalise investigations of complex conditions with minimal oversight.
  • You will initiate deviations, be accountable for CAPA investigation and closure as required.
  • You will oversee projects that are large and complex independently and with minimal oversight.
  • Evaluate impact of process / equipment or procedural changes that can affect the validated state of the equipment.
  • To manage complex capital projects with minimal oversight from start to finish.
  • Review process, SIP and CIP flowpaths with engineering, participate in the commissioning plan / effort where needed.

Requirements:

  • To be educated at a B.S / M.S degree or equivalent in technical area preferred, with substantial experience in pharmaceutical, biotechnology or related industry.
  • Capability to read and follow technical instructions in English.
  • Ability to comply with detailed procedures.
  • To be able to achieve math with assistance from a calculator
  • Excellent knowledge of Word, Excel, Outlook, Project or equivalents.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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