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Senior Validation Engineer

Location:
Dublin, Dublin City
Posted:
13/08/2019 (14:22)
Agency:
Headcount Solutions Limited
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Senior Validation Engineer

Headcount Engineering is actively seeking a Senior Validation Engineer for our client’s biopharma facility in Dublin.  This person will provide Validation oversight of External Manufacturing sites (API, DS/DP), including process, cleaning, filter and sterilization/sanitization validation activities. 

There is some flexibility flexible on working hours and potentially some scope to work from home occasionally 


Main Responsibilities: 

  • Translates client requirements into the language of the CMO-can make a risk-based decision. 
  • Validation document author/approver. 
  • Ensure validated parameters are correctly incorporated in Master Batch Records 
  • Regulatory - Aseptic processing system oversight (media fill, autoclave validation, EM) content authorship. 
  • Validation change control assessment. 
  • Author applicable MA filing sections. 
  • Write/review RTQs. 
  • Prepare inspection playbooks. 
  • Drive Operational Excellence and Champion Change. 
  • Determine validation strategy and outcome of validation activities.
  • Decision to approve or reject validation documentation. 
  • Provide Validation position on related topics and strategy for the site. 

Requirements: 

  • Degree qualified in science and/or engineering.
  • Ideally 8+ years biotech or pharmaceutical industry experience. 
  • Significant Validation experience at Aseptic Manufacturing or API facilities. 
  • Able to successfully manage workload and timelines. 
  • Familiarity with basic project management tools. 
  • Ability to negotiate a strategic position after taking feedback from multiple sources (dealing with CMOs, communicate with others where English isn't first language). 
  • Strong project management, problem-solving, and analytical skills. 
  • Ability to operate in a matrixed or team environment with site, functional, and executive leadership.

For further information, please contact Mick on (phone number removed) or forward details in confidence to jobs@headcount.ie 

Type:
Contract
Start Date:
ASAP  
Contract Length:
Minimum 12 months  
Telephone:
Job Reference:
1308MQ  
Job ID:
210601240  
Applications:
Less than 10

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