Validation Engineer, Cleaning Validation (12M, Cork)

VALIDATION ENGINEER with 3+ years CLEANING VALIDATION experience from the BioPharma industry required by CareerWise for our multinational BioPharma client at their facility in Cork.

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• Initial 12 month contract.
  
• Chemical Engineering degree (ideally) required.
  
• 3+ years in a Cleaning Validation role in the Biopharma industry required.
  

No sponsorship is provided for this role so applicants need to already have Irish / EU citizenship OR the relevant Stamp / Visa in place.

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• Active engagement with the MSAT team, delivering a successful outcome to all MSAT validation activities using Good Manufacturing Practices (GMP).
  
• Primary activities are in the Cleaning Validation area. Planning, documenting and performing cleaning validation studies. Leading and/or providing technical guidance for cleaning/ process improvement projects and investigations.
  
• Leading and/or providing technical guidance for process improvement projects and investigations.
  
• Secondary activities include, but are not limited to Thermal Validation, Process support Validation, Supporting process improvement projects, Supporting New product Introduction/ process validation, GMP documentation generation (e.g. protocols / SOPs / WIs / Technical Documents, Exception/Event Investigations).
  

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• Conduct MSAT activities in compliance with US and EU regulations, procedures and EHS&S requirements.
  
• Develop MSAT documentation (e.g. strategies, plans, protocols, procedures, reports) and co-ordinate MSAT document review and approval.
  
• Review and approve documents prepared by other MSAT colleagues.
  
• Field execution of MSAT protocols.
  
• Liaise with Manufacturing to provide support where required with routine operations / project-based work.
  
• Compile relevant information from contractors, suppliers, and other departments to develop technical reports.
  
• Representing the MSAT site team on platform technical teams.
  
• Initiate and implement change control activities in accordance with site procedures.
  
• Track and resolve exceptions/events/deviations during MSAT activities.
  
• Prioritize MSAT activities in line with Manufacturing / project schedules.
  
• Co-ordinate MSAT activities with contractors and vendors as required.
  
• Attend identified training, required to fulfill the role of a MSAT Engineer.
  
• Participate in multi-functional teams (project, investigations) as required.
  

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• Excellent interpersonal skills.
  
• Ability to operate as part of a team is essential.
  
• Proven leadership skills and critical thinking ability.
  
• Excellent communication skills both written and verbal.
  
• Innovative with great problem-solving skills.
  
• Results and performance driven.
  
• Adaptable and flexible.
  
• Integrity, trustworthiness and objectivity.
  
• Knowledgeable of FDA/EMEA regulatory requirements.
  

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• A minimum of a Degree in Engineering, Molecular Biology, Biochemistry, Pharmacy or related scientific field is required.
  
• At least 2 yrs experience in the Large Molecule manufacturing industry or equivalent.
  
• Focus on patients and customers at all times.
  
• Experience in Cleaning validation studies and Cleaning strategy (Minimum 2 years).
  
• Also, beneficial would be experience in Thermal Validation, Process Validation, Supporting process improvement projects, Supporting New product Introduction.
  
• Ability to interact at different levels of the organization, perform under pressure and handle conflicting interests.
  
• Ability to work independently under general direction, having a good sense of prioritization of goals and good time management.
  
• Ability to lead multi-functional team and to manage complexity and change.
  
• Proven knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.
  

Please call Conor Twomey today for further information on or email:

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. xcfaprz

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.