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Equipment Validation Specialist

Employer
Hobson Prior
Location
Maryland, Walkersville, USA
Salary
£50850.93 - £59052.70 per annum
Start date
21 Apr 2021
Closing date
19 May 2021

View more

Discipline
Manufacturing, Engineering
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

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.

Company

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Company info
Website
Telephone
01892 612 612
Location
Wellington Gate
7-9 Church Rd
Tunbridge Wells
TN1 1HT
United Kingdom

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