Validation Engineer

3 weeks ago

Municipal District of Carlow, Ireland RT.Lane Full time

R.T. Lane Recruitment are currently recruiting for a Validation Engineer to work with a Pharmaceutical Company in Carlow.

This is a 12-month contract with potential extension past this time period.

Please note that candidates must hold the correct working visa for Ireland as my client cannot offer visa assistance and must be already residing in Ireland.

Please note due to a high volume of applicants you will only be contacted if suitable for the position.

Brief outline of Role:

  1. Primary responsibilities for the Validation Engineer include the following:
  2. Project validation support including conducting equipment performance qualifications (specifically cleaning and sterilization validation).
  3. Authoring project validation master plans; SOP and documentation updates.
  4. Authoring validation protocols and final reports, executing validation studies, analysis of validation data.
  5. Resolving technical issues encountered during study execution.
  6. The successful candidate will be required to work in a cross-functional team and independently to accomplish validation project objectives.
  7. Minimal work direction needed, highly skilled and knowledgeable to the position.

Roles and Responsibilities:

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.
  • Cleaning Validation in Biotech facility & Cleaning Processes.
  • Sterilisation – Autoclave & Load Qualification.
  • Single Use Technologies – SUT and SU components/ manifolds.
  • Filter Validation – Sterilising and Bioburden reducing Filter Validation & Process Validation.
  • Ancillary Equipment for Bio-processing – Tube Welders/ Sealers/ Filter Integrity / Glove Integrity Testing.
  • Formulation processing using DeltaV including Transfer Panel and Utility Qualification.
  • Parenteral Product Visual Inspection (Automated Inspection).
  • High Potency and ICH Q5 products & containment methodologies.

The successful candidate should have demonstrated experience in at least 2 of these key areas and alongside new facility introduction experience.

Experience, Knowledge & Skills:

  • Minimum 6 years C&Q/ QA/ QC/ Validation experience in highly regulated industry.
  • Minimum 2 years process equipment C&Q/QA/Validation experience on Greenfield / Brownfield, Large Scale Project or new facility introduction.
  • Presenting of QA / QC / Validation documents to regulatory agencies/ inspectors and defending approach.
  • SME on Equipment Qualification on any; Cleaning & Parts Washers for in-process components / Vaporised Hydrogen Peroxide Isolators / Clean Utilities & Transfer Panels / Vial & Syringe Filling & Inspection.
  • Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines.
  • Experience with liaising with other departments – Engineering, Automation, Technical, Operations, EHS and QA.
  • Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.

Qualifications & Education:

  • Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences, Computer Sciences or applied Technical / Engineering qualification.
  • The successful candidate will also have a proven track record in delivering excellence.

For more information or a full Job Description please contact – Michelle Power, R.T. Lane Recruitment on 022 46969, 087 032 8195 or email michelle@rtlanerecruitment.ie.

#J-18808-Ljbffr

  • Validation Engineer

    3 weeks ago

    Municipal District of Carlow, Ireland Asset Recruitment Full time

    ref. 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 &...

  • Validation Engineer

    4 weeks ago

    Municipal District of Carlow, Ireland Asset Recruitment Full time

    ref. 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 &...

  • Validation Engineer

    3 weeks ago

    Municipal District of Carlow, Ireland PSC Biotech Corporation Full time

    About PSC BiotechWho 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 Regulatory...

  • Validation Engineer

    4 weeks ago

    Municipal District of Carlow, Ireland PSC Biotech Corporation Full time

    About PSC BiotechWho 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 Regulatory...

  • Validation Engineer

    15 hours ago

    The Municipal District of Carlow, Ireland PE Global Full time

    PE Global is currently recruiting for a Validation Engineer for a leading multi-national Biologics client based in Carlow. This is an initial 11-month contract position.The successful candidate will support Cleaning Validation including Recovery/Cleanability studies.The role:Design/Author/Review/Approve/Execute qualification/validation documentation and...

  • Senior CQ/ Validation Engineer

    4 weeks ago

    Municipal District of Carlow, Ireland PSC Biotech Corporation Full time

    Job DescriptionAbout PSC BiotechWho 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...

  • Senior CQ/ Validation Engineer

    3 weeks ago

    Municipal District of Carlow, Ireland PSC Biotech Corporation Full time

    Job DescriptionAbout PSC BiotechWho 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...

  • Validation Process Engineer

    2 days ago

    The Municipal District of Carlow, Ireland ENG Bauen Full time

    About the CompanyENG Bauen is a global talent management and advisory consultancy specializing in the Pharmaceutical and Energy sectors. Our expertise lies in developing workforce strategies for businesses executing capital projects. Our mission is to ensure seamless resource deployment across all project lifecycle phases, including FEED, Detailed Design,...

  • Validation and Compliance Engineer

    12 hours ago

    The Municipal District of Carlow, Ireland PE Global Full time

    PE Global is currently looking for a highly skilled Validation and Compliance Engineer to join our team. In this role, you will be responsible for validating equipment and processes, ensuring compliance with regulatory requirements, and driving continuous improvement through Lean Six Sigma methodologies.The successful candidate will have significant...

  • CQV/Validation Engineer

    4 weeks ago

    Municipal District of Carlow, Ireland CAI Full time

    About CAICAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.Are you Ready?Our approach is simple;...

  • Validation Engineer

    3 weeks ago

    Carlow, Ireland Recruitment by Aphex Group Full time

    This 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....

  • Validation Engineer

    3 days ago

    Carlow, Ireland Recruitment By Aphex Group Full time

    This 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...

  • Validation Engineer

    2 days ago

    The Municipal District of Carlow, Ireland PE Global Full time

    PE Global is seeking a highly skilled Validation Engineer to join our team in a GMP manufacturing environment.About the RoleThe successful candidate will be responsible for supporting Cleaning Validation, including Recovery/Cleanability studies, and will work closely with production, maintenance, and quality teams to ensure seamless execution of Cycle...

  • Validation Engineer

    2 days ago

    Carlow, Ireland Recruitment by Aphex Group Full time

    These 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,...

  • Validation Engineer

    2 weeks ago

    Carlow, Ireland PSC Biotech Ltd Full time

    Job 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...

  • CQV/Validation Engineer

    15 hours ago

    The Municipal District of Carlow, Ireland CAI Full time

    About CAICAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.Are you Ready?Our approach is simple;...

  • Cleanroom Validation Specialist

    2 days ago

    The Municipal District of Carlow, Ireland ENG Bauen Full time

    About the RoleWe are seeking a Senior Validation Engineer to join our team at ENG Bauen, a global talent management and advisory consultancy specializing in the Pharmaceutical and Energy sectors.The successful candidate will have hands-on project experience and a strong background in project delivery, from concept to commissioning, qualification, and...

  • Validation Engineer

    1 week ago

    Carlow, Ireland Recruitment by Aphex Group Full time

    This 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...

  • Engineering Validation Professional

    1 day 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...

  • Validation Engineer

    16 hours ago

    Carlow Town, Co. Carlow, Ireland Recruitment by Aphex Group Full time

    These 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,...