Collins McNicholas

Role Responsibilities:

  • Active engagement with the Technical Operations team, delivering a successful outcome to all Technical Operations activities using Good Manufacturing Practices (GMP).
  • The primary responsibility will be Cleaning Validation.
  • Other activities may include Performance Qualification (e.g. Steam-In-Place PQs), Process Validation Support (e.g. Mixing Studies, Media Challenge), Process Validation, Change Control, Exception/Event Investigations/Closure. 

Role Requirements:

  • Bachelor’s Degree in a scientific/technical discipline required 
  • Focus on patients and customers at all times. 
  • 5+ Years Cleaning Validation Experience. 
  • Experience in a large molecule start-up facility. 
  • Experience in other Validation areas (e.g. Performance Qualification (e.g. Steam-In-Place PQs), Process Validation Support (e.g. Mixing Studies, Media Challenge), Process Validation). 
  • Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply cGMP regulations and guidelines to all aspects of Technical Operations activities. 
  • Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.
  • Excellent interpersonal skills 
  • Ability to operate as part of a team is critical. 
  • Excellent communication skills both written and verbal 
  • Attention to detail 
  • Good problem-solving skills 
  • Results and performance driven 
  • Adaptable and flexible 
  • Integrity, trustworthiness and objectivity 
  • Knowledgeable of FDA/EMEA regulatory requirements

For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email josh.barnes@collinsmcnicholas.ie

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