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Vacancy Details

Engineering & Technical

Senior Validation Engineer - Contract - Limerick

Contract Type: Contract
Sector:
Location: Limerick
Date: 30/05/2019
Job Reference: 102520
Contact Name: Anna Carty
Contact Email: careers@hero.ie

Job Description

Senior Validation Engineer – Contract

Our client, a medical device company in Limerick are currently looking to recruit a Senior Validation Engineer for their site on a contract basis.

Description:
  • The Validation Engineer is a member of the QA Validation team, playing a key role in the planning and execution of validation activities related to project.
  • Provide input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project, is critical to the start-up, license approval and the on-going sustaining operations of facilities.
  • All validation activities are conducted in compliance with US and EU legislation; as well as company Standards and Guidelines to allow a facility to be qualified in accordance with the project requirements of quality, safety, schedule and budget. Primary Tasks and
  • Responsibilities
  • Conduct validation activities in compliance with US and EU regulations, GBSC procedures and EHS requirements.
  • Participate in the design of systems and equipment to ensure that they comply with GMP requirements.
  • Develop validation documentation as required (e.g. specifications, plans, protocols, procedures).
  • Review and approve documents prepared by the validation team, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls).
  • Execute qualification protocols as required.
  • Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.
  • Prepare reports of executed protocols for review by QA.
  • Initiate and implement change control activities in accordance with site procedures.
  • Track and resolve exceptions during qualification activities.
  • Prioritize qualification activities in line with the project schedule.
  • Co-ordinate qualification activities with engineering, construction and commissioning activities.
  • Co-ordinate qualification activities with contractors and vendors as required.
  • Co-ordinate qualification document review and approval.
  • Collate and organize qualification files for turnover to QADC.
Other Skills, Experience and Education
  • A degree qualification in science or engineering.
Desirable:
The person will have a proven track record in the qualification of any of the following systems:
  • Qualification of Cell Culture Technologies.
  • Qualification of Purification – Chromatography and Ultrafiltration Technologies.
  • Qualification of Production Support Equipment.
  • Qualification of Clean Utilities.
  • Qualification of HVAC (ISO classes 5 to 8).
  • Qualification of Control Systems – Emerson DeltaV, Honeywell Building Management Systems and Siemens PLCs.
  • Qualification experience in a project environment within the pharmaceutical or biopharmaceutical industries.
  • Knowledge and Interpretation of FDA/EMEA requirements applicable to the pharmaceutical or biopharmaceutical industries. Ability to apply CGMP regulations and guidelines to all aspects of qualification activities.

Key Competencies Required
  • Excellent interpersonal skills
  • Ability to operate as part of a team is critical and also the ability to work alone as required
  • Customer focus
  • Excellent communication skills both written and verbal
  • Attention to detail
  • Good problem solving skills
  • Results and performance driven
  • Adaptable and flexible
All applicants must have a working visa for Ireland for this contract role

For further information on this Validation Engineer role in Limerick please contact Anna Carty on 086 8168298 / careers@hero.ie
Check out all our open jobs on our HERO Recruitment website – www.hero.ie

Please Note: HERO Recruitment will not forward your details to any company without your prior approval

Clients we are proud to work with

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“I have worked with HERO recruitment (formerly HERO recruitment) for a number of years both within my current and previous position. I have always found HERO recruitment excellent to partner with, the consultants know our industry and cultural fit and can therefore successfully source high calibre candidates to match our open vacancies. I find HERO recruitment very professional to deal with and any candidates I interview who are sourced by HERO always have a positive recruitment experience”.

Moira Faherty,
Human Resources Manager
Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

Adrian Rice,
Engineering Manager 
Boston Scientific

“HERO have been a key strategic recruiting partner to Hollister ULC over many years. During our continued growth and expansion at our facility in Ballina, Hero have worked closely with us to really understand our recruiting needs, the calibre of talent we are looking for, and the fit for our Hollister culture. HERO have successfully sourced and placed candidates for us into Research and Development, Project / Process Engineering, Supply Chain and key Management roles.  They have a very experienced and professional team, and bring an excellent regional, national and international perspective”. 

Tom Horkan,
Asst. HR Manger
Hollister ULC, Ballina, Co. Mayo

"From the first prompt call-back to the ultimate congratulatory call to inform me of a job offer, Karl was an absolute professional; sound advice, solid research and knowledge of companies, unwavering persistence and friendly encouragement. West is best, so for anyone looking for a technical role, talk to Karl"

Fiachra Collins
Computer Vision Algorithm Team Manager
Valeo

“HERO Recruitment continues to be a valued partner in supplying high calibre candidates to all three Boston Scientific sites in Ireland. In particular they have been successful in delivering on specific roles for key project scale-ups. HERO has also provided on-site recruitment presence during increased activity when required and consistently operate in a highly professional and competent manner”.   

Lorraine McDonnell,
Senior Talent Acquisition Specialist
Boston Scientific 

“HERO Recruitment were instrumental in sourcing and delivering key talent to the organisation and enabled us to meet our key deliverables within our start-up phase. They thoroughly understood our culture and constantly over delivered on our expectations. Our partnership with HERO Recruitment has without a doubt been  a professional and collaborative one. HERO exceed themselves in all aspects of recruitment and are an absolute pleasure to work with”.

Christine Power,
VP of Human Resources
Pivot

“HERO recruitment is an extension to our talent acquisition team. From hiring strategy meeting to the induction of the right talent, the HERO recruitment team provide an exemplary service. They are knowledgeable about our business needs, responsive and thorough. A true talent acquisition partner”. 


Orla Keady-Giblin,
Human Resources Manager
Ingersoll Rand – Thermo King
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“I have worked with HERO recruitment (formerly HERO recruitment) for a number of years both within my current and previous position. I have always found HERO recruitment excellent to partner with, the consultants know our industry and cultural fit and can therefore successfully source high calibre candidates to match our open vacancies. I find HERO recruitment very professional to deal with and any candidates I interview who are sourced by HERO always have a positive recruitment experience”.

Moira Faherty,
Human Resources Manager
Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

Adrian Rice,
Engineering Manager 
Boston Scientific

“HERO have been a key strategic recruiting partner to Hollister ULC over many years. During our continued growth and expansion at our facility in Ballina, Hero have worked closely with us to really understand our recruiting needs, the calibre of talent we are looking for, and the fit for our Hollister culture. HERO have successfully sourced and placed candidates for us into Research and Development, Project / Process Engineering, Supply Chain and key Management roles.  They have a very experienced and professional team, and bring an excellent regional, national and international perspective”. 

Tom Horkan,
Asst. HR Manger
Hollister ULC, Ballina, Co. Mayo

"From the first prompt call-back to the ultimate congratulatory call to inform me of a job offer, Karl was an absolute professional; sound advice, solid research and knowledge of companies, unwavering persistence and friendly encouragement. West is best, so for anyone looking for a technical role, talk to Karl"

Fiachra Collins
Computer Vision Algorithm Team Manager
Valeo

“HERO Recruitment continues to be a valued partner in supplying high calibre candidates to all three Boston Scientific sites in Ireland. In particular they have been successful in delivering on specific roles for key project scale-ups. HERO has also provided on-site recruitment presence during increased activity when required and consistently operate in a highly professional and competent manner”.   

Lorraine McDonnell,
Senior Talent Acquisition Specialist
Boston Scientific 

“HERO Recruitment were instrumental in sourcing and delivering key talent to the organisation and enabled us to meet our key deliverables within our start-up phase. They thoroughly understood our culture and constantly over delivered on our expectations. Our partnership with HERO Recruitment has without a doubt been  a professional and collaborative one. HERO exceed themselves in all aspects of recruitment and are an absolute pleasure to work with”.

Christine Power,
VP of Human Resources
Pivot

“HERO recruitment is an extension to our talent acquisition team. From hiring strategy meeting to the induction of the right talent, the HERO recruitment team provide an exemplary service. They are knowledgeable about our business needs, responsive and thorough. A true talent acquisition partner”. 


Orla Keady-Giblin,
Human Resources Manager
Ingersoll Rand – Thermo King
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Clients we are proud to work with

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