Senior Validation Engineer
1 week ago
PE Global is recruiting for a Senior Validation Engineer on behalf of our pharmaceutical client in County Carlow. This is an initial 12-month contract, hybrid role. Our Carlow site is excited to offer a fantasticSeniorEngineering Specialist (Validation)opportunity for candidates interested in a new challenge in a cGMP regulatory environment. The successful candidate will support Cleaning Validation including Recovery/Cleanability studies. What you will do: Bring energy, knowledge, innovation to carry out the following: Design/Author/Review/Approve/Execute qualification/validation documentation and cycle development studies in line with the standard approval process. Design/Author/Review/Approve/Execute Execution/development of change controls. Resolving technical issues encountered during study execution. Engagement with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities. Technical input into quality notification by authoring/reviewing/approving investigations. Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues. Support continuous improvement through Lean Six Sigma methodologies. Serve as validation representative for cross functional projects and represent the validation team at global technical forums Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections and proactively highlighting any issues around compliance Supporting regulatory audits and submissions as required. Work collaboratively to drive a safe and compliant culture in Carlow. May be required to perform other duties as assigned. What skills you will need: In order to excel in this role, you will more than likely have: Experience in cleaning validation including but not limited to CD & PQ of mobile vessels (CIP) and parts washers (COP) including recipe development & optimisation, cleaning verification, cleanability and recovery studies using TOC, ICP & swab methods, acceptable residual limit determination, worst case soil matrices & strategy development. Considerable experience in a comparable role, with experience operating as individual contributor adding value to the business in a GMP manufacturing setting, as well as the following qualifications/skills: Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence. Exception / Deviation Management and Change Control. Demonstrable experience of leading technical related projects. Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable Evidence of continuous professional development is desirable. Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices. Ability to analyse and interpret complex data, and link to equipment performance and out of specification findings as appropriate. Report, standards, policy writing skills required. Equipment and process validation. Sterile Fill-Finish processes and equipment. Proficiency in Microsoft Office and job-related computer applications Excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team oriented manner. Knowledge and experience of the below areas will be considered advantageous. Filter Validation CCI qualification Shipping Qualification Equipment Periodic Validation Equipment Validation Lifecycle Project Management Skills/Qualification Autoclave/SIP Sterilisation Validation Dry Heat Sterilisation Isolator VHP/HVAC Qualification Controlled Temperature Units/Equipment Qualification Vial and Syringe Processing Technologies Interested candidates should submit an updated CV. Please click the link below to apply, call Paul Wheatley on or alternatively send an up-to-date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland*** Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. Skills: Validation Temperature Unit Autoclave
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Validation Engineer
3 weeks ago
Carlow, Ireland Recruitment by Aphex Group Full timeThis is a 12-month contract with a view to extension. Purpose The role will require the leadership of an experienced, energetic, and committed Senior/ Lead Engineering (CQV/ Technical Engineer) with broad experience in Vial and Syringe Filling operations and the below key areas. Vial and Syringe Sterile operations Isolators, VHP, decontamination systems....
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Validation Engineer
4 days ago
Carlow, Ireland Recruitment By Aphex Group Full timeThis is a 12-month contract with a view to extension.Purpose The role will require the leadership of an experienced, energetic, and committed Senior/ Lead Engineering (CQV/ Technical Engineer) with broad experience in Vial and Syringe Filling operations and the below key areas.Vial and Syringe Sterile operations Isolators, VHP, decontamination...
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Carlow, Ireland PSC Biotech Ltd Full timeJob DescriptionAbout PSC Biotech Who are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...
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Carlow, Ireland PSC Biotech Ltd Full timeAbout PSC Biotech Who are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory...
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Carlow, Ireland PSC Biotech Ltd Full timeAbout PSC Biotech Who are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory...
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Carlow Town, Co. Carlow, Ireland Life Science Recruitment Ltd Full time11 month contract Senior Validation Engineer - Cleaning On site Carlow AMC22966 We are currently hiring for a Senior Validation Engineer role with a rapidly expanding biopharmaceutical manufacturer based in Carlow. In this role you will support Cleaning validation on site. The ideal candidate will have 5+ years of experience in validation of sterile fill...
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Senior Validation Engineer
7 days ago
Carlow Town, Co. Carlow, Ireland PE Global Full timePE Global is recruiting for a Senior Validation Engineer on behalf of our pharmaceutical client in County Carlow. This is an initial 12-month contract, hybrid role. Our Carlow site is excited to offer a fantasticSeniorEngineering Specialist (Validation)opportunity for candidates interested in a new challenge in a cGMP regulatory environment. The successful...
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The Municipal District of Carlow, Ireland Headcount Solutions Full timeSenior Validation EngineerHeadcount Solutions is seeking a Senior Validation Engineer for our client's biopharma facility. This role will support Cleaning Validation including Recovery/Cleanability studies.Main Responsibilities:Design/Author/Review/Approve/Execute qualification/validation documentation and cycle development studies in line with the standard...
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Validation Engineer
2 days ago
Carlow, Ireland Recruitment by Aphex Group Full timeThese are 11-month contracts with a view to extension. Purpose Our Carlow site are excited to offer a fantastic Engineering Specialist (Validation) opportunity for candidates interested in a new challenge in a cGMP regulatory environment. The successful candidates will support several aspects of Validation. The roles available that will require experienced,...
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Carlow, Ireland Life Science Recruitment Ltd Full time11 month contract Senior Validation Engineer - Cleaning On site Carlow AMC22966 We are currently hiring for a Senior Validation Engineer role with a rapidly expanding biopharmaceutical manufacturer based in Carlow. In this role you will support Cleaning validation on site. The ideal candidate will have 5+ years of experience in validation of sterile fill...
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Validation Engineer
2 weeks ago
Carlow, Ireland PSC Biotech Ltd Full timeJob DescriptionAbout PSC Biotech Who we are? PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...
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Validation Engineer
1 week ago
Carlow, Ireland Recruitment by Aphex Group Full timeThis is an 11-month contract and is a hybrid position, About the Role: We are seeking a highly skilledValidation Engineer to join our team in a cGMP regulatory environment. This is an exciting opportunity for an experienced professional to take on a challenging role, focusing onCleaning Validation, includingRecovery/Cleanability studies, and driving...
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Carlow, Ireland Psc Biotech Ltd Full timeJob Description About PSC Biotech Who are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide.We provide cloud-based software solutions for Quality Management and...
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Municipal District of Carlow, Ireland Asset Recruitment Full timeref. 01250Validation EngineerAsset Recruitment is recruiting a Validation Engineer for a 12-Month contract role, with a high likelihood for extension, on behalf of our client, a growing pharmaceutical manufacturer in Carlow.RoleAs part of a significant expansion project, the successful candidate will join their science, engineering/ manufacturing &...
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Validation Engineer
4 weeks ago
Municipal District of Carlow, Ireland Asset Recruitment Full timeref. 01250Validation EngineerAsset Recruitment is recruiting a Validation Engineer for a 12-Month contract role, with a high likelihood for extension, on behalf of our client, a growing pharmaceutical manufacturer in Carlow.RoleAs part of a significant expansion project, the successful candidate will join their science, engineering/ manufacturing &...
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Engineering Validation Professional
2 days ago
Carlow, Ireland Recruitment by Aphex Group Full time**Overview of the Role**About the JobWe are looking for an experienced Validation Engineer to join our team in Carlow. As a key member of our engineering department, you will be responsible for supporting the validation of various equipment and systems within our cGMP manufacturing environment.The ideal candidate will have a strong background in applied...
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Senior Validation Engineer-Hybrid
1 week ago
Carlow, Ireland PSC Biotech Ltd Full timeJob DescriptionAbout PSC Biotech Who are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...
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Senior Validation Engineer-Hybrid
7 days ago
Carlow, Ireland Psc Biotech Ltd Full timeAbout PSC Biotech Who are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide.We provide cloud-based software solutions for Quality Management and Regulatory...
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Senior Validation Engineer-Hybrid
1 week ago
Carlow, Ireland PSC Biotech Ltd Full timeAbout PSC Biotech Who are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory...
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Validation Engineer
2 days ago
Carlow Town, Co. Carlow, Ireland Recruitment by Aphex Group Full timeThese are 11-month contracts with a view to extension. Purpose Our Carlow site are excited to offer a fantastic Engineering Specialist (Validation) opportunity for candidates interested in a new challenge in a cGMP regulatory environment. The successful candidates will support several aspects of Validation. The roles available that will require experienced,...
