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Vacancy Details

Engineering & Technical

Technical Operations Engineer - Cork

Sector:
Location: Cork
Date: 15/01/2018
Job Reference: 91979

Job Description

Contact: Caroline Kingston
Email: caroline@hero.ie
Telephone: 0868395531

Technical Operations Engineer
Our client, a medical device company in Cork are currently looking to recruit a Technical Operations Engineer for their site.

Description:
The Technical Operations Engineer is a member of the Technical Operations (TO) Team with the dedicated focus on
  • Continued Process Verification
  • Process Validation
  • Process Improvements
  • Leading complex cross functional investigations
  • Standards and new technology deployment
  • The Technical Operations Engineer will report solid line to the TO Director
  • The Technical Operations Engineer is a key contributor to LCM and process improvement initiatives on the site.
Main Duties & Responsibilities
Life Cycle Management
  • Manage/execute the validation program related to LCM for post-stage gate 12 products
  • Issue/review validation plan, protocols and reports
  • Be the siteTO representative in LCM/NPI project teams as process/validation SME
  • As required coordination of LCM projects on site, under responsibility of global TO organization
Technology & product technical lifecycle management
  • Own/participate in the CPV program by issuing plans, protocols and reports and oversee the execution.
  • Lead complex investigations on the site by providing technical expertise
  • Provides process/technology input to SOP’s, Master Batch Records and change controls
  • Partner with Engineering & Maintenance and contribute to equipment changes/introduction projects on the site
Innovation & Standardization
  • Identify / lead / contribute to process improvement projects, including new technology / analytics introduction (e.g. PAT, MVA)
  • Contribute to Standardization initiatives for Technical Operations
Inspection Readiness and Execution
  • Technical support / direct participation in partnership with Quality / Operations on any regulatory audits and inspections
  • Technical Owner
  • The TO engineer can also take the role of an API Technical Owner in consultation with global Technical Operations
Key Competencies Required
Specific knowledge
  • Strong expertise on pharmaceutical manufacturing (Small Molecule API) processes and equipment, specifically for the applicable technology platform
  • Project management (FPX or other) – team member / project lead
  • Process excellence (6sigma), lean concepts and statistical skills
  • Strong knowledge of Quality & Compliance / regulatory requirements (GMP/EH&S) especially for Technology Platform.
Personal and interpersonal skills / Leadership skills
  • Ability to lead cross functional team and to manage complexity and change
  • Ability to interact at different levels of the organization, work under pressure, handle conflicting interests
  • Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly
  • Team player with well-developed problem solving skills
Personal attitude and mind-set
  • Drives for innovation and change to ensure competitiveness
  • Can-do mentality, agility & flexibility able to work with stretched goals and deadlines
Qualifications & Experience
Essential:
  • University degree in Engineering or Science, with minimum 5 years’ experience in a pharmaceutical environment
  • And/or an equivalent combination of education and experience in API Manufacturing and Purification for small/large molecules, Quality Assurance and Regulatory, Validation
Desirable:
  • Master Degree or Equivalent with 5 – 8 years’ experience in a pharmaceutical environment.
For further information on this Technical Operations Engineer role in Cork please contact Caroline Kingston on 0868395531 / caroline@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

“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

“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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