Connecting to LinkedIn...

Vacancy Details

Engineering & Technical

Senior Validation Engineer - Cork - 102999

Contract Type: Contract
Location: Cork
Date: 14/03/2019
Job Reference: 102999
Contact Name: Nick Harrison
Contact Email:

Job Description

Senior Validation Engineer - Cork - 102999
Senior Validation Engineer

Our client, a pharmaceutical company in Cork is currently looking to recruit a Senior Validation Engineer for their site in Cork on a contract basis

Job Purpose:

The primary purpose of this job is to support major Manufacturing Engineering Projects.
The position is part of a team within the Engineering department that contributes to the overall business metrics. This position will provide project leadership on continuous improvement, and risk mitigation initiatives and will also include liaison with outside suppliers and other manufacturing sites to ensure all goals and targets of the manufacturing process are achieved

Principle Accountabilities:
  • Competent in validation requirements on new processes, equipment introductions & process changes.
  • Responsible for performing process validation studies by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements.
  • Process Validation for process creation
  • Process Validation for the transfer of processes within the facility.
  • Defines the requirements for Process Validation studies in alignment with approved SOPs.
  • Executes test plans according to approved procedures, performs sampling, tabulates test results, and organizes data packages.
  • Compiles and analyses validation data, prepares reports and makes recommendations for changes and/or improvements.
  • May also investigate and trouble-shoot problems which occur, and determine solutions.
  • Coordinates and executes validation change control and preparation of draft protocols, reports and data tables.
  • Maintains and archives all documentation pertaining to validation.
  • Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups.
  • As required, prepares summaries of validation testing for regulatory submissions, and presents validations to regulatory agencies.
  • Independently applies validation principles to work assignments, reviews and approves documents and resolves problems.
  • Coordinates assigned projects and represents department on project teams.
  • Resolves validation issues of moderate scope with limited direct supervision

    Key Competencies Required:
  • Ability to manage multiple assignments or projects with sound analytical, troubleshooting, and problem solving skills.
  • Flexible work ethic.
  • Strong influencing skills.
  • Excellent communication skills (written and oral).
  • Problem solving skills – to assist in maintaining project progress and on design issues.
  • Decision Making – required to make decisions on technical issues.
  • Degree of responsibility – must be capable of taking direction and taking responsibility and ownership for systems.
  • Excellent planning & organisation skills.
  • Extent of confidentiality - discretion is essential in view of contact with outside parties, product development strategies, regulatory and sales information.
  • Continuous Improvement Focus

Qualifications & Experience:
  • Extensive understanding and application of validation principles, concepts, practices, and standards particularly in relation to Process Validation.
  • Proficient in current Good Manufacturing Practices (GMPs).
  • Full knowledge of industry practices.
  • Strong verbal, written, and interpersonal communication skills are required.
  • Investigation and report writing skills.
  • Proficient in Microsoft Office applications.
  • Degree qualified in a relevant Engineering / Science discipline, with 5+ years relevant experience.
  • Experience in Statistical analysis is essential.
  • Experience in regulated industry, FDA, ISO, etc.
  • Demonstrated leadership skills and the ability to make effective decisions

For further information on this Senior Validation Engineer role in Cork please contact Nick Harrison on 086 0468858 /

Check out all our open jobs on our HERO Recruitment website –
Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Share this Job

“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

“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

“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

Clients we are proud to work with