Current jobs related to Senior Validation Engineer-Hybrid - Carlow - PSC Biotech Ltd

  • Senior Validation Engineer-Hybrid

    2 weeks ago

    The Municipal District of Carlow, Ireland PSC Biotech Corporation Full time

    About 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 Regulatory...

  • Validation Engineer

    3 weeks 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 skilled Validation Engineer to join our team in a c GMP regulatory environment.This is an exciting opportunity for an experienced professional to take on a challenging role, focusing on Cleaning Validation, including Recovery/Cleanability studies, and driving...

  • Senior Validation Engineer

    3 weeks ago

    Municipal District of Carlow, Ireland ENG Bauen Full time

    Cleaning Validation Engineer | Contract | IrelandENG 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,...

  • Senior Cq/ Validation Engineer

    1 week ago

    Carlow, Ireland Psc Biotech Ltd Full time

    Job 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...

  • Senior Cq/ Validation Engineer

    1 week ago

    Carlow, Ireland Psc Biotech Ltd Full time

    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 Regulatory...

  • Senior Cq/ Validation Engineer

    7 days ago

    Carlow, Ireland Psc Biotech Corporation Full time

    Industry Pharma/Biotech/Clinical ResearchWork Experience 5+ yearsCity CarlowState/Province CarlowCountry IrelandJob DescriptionAbout PSC Biotech 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...

  • Senior Validation Engineer

    7 days ago

    Carlow, Ireland Psc Biotech Corporation Full time

    **Job Description**About Psc Biotech CorporationPsc Biotech Corporation is a leading biotech consultancy firm founded in 1996, headquartered in Pomona, California, USA. Our global operations span Ireland, India, Singapore, Australia, and the US, serving over 350 clients across 23 countries worldwide.We provide cloud-based software solutions for quality...

  • Senior Technical Transfer Engineer

    2 weeks ago

    Carlow Town, Co. Carlow, Ireland Life Science Recruitment Ltd Full time

    Were currently recruiting for an exciting opportunity with an award winning biopharmaceutical organization. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties Required to be compliant via documentation completion, risk assessments, closing out corrective action, participate...

  • Validation Engineer

    3 weeks ago

    Carlow, Ireland Claran Consultants Ltd Full time

    Role Description We 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, energetic and committed engineers are in the following...

  • Validation Engineer

    3 weeks ago

    Carlow, Ireland Life Science Recruitment Ltd Full time

    11 month contract Validation Engineer On site Carlow AMC22979 We are currently hiring for a Validation Engineer role with a rapidly expanding biopharmaceutical manufacturer based in Carlow. In this role you will support various areas of validation on site including Sterilization, cleaning, isolators, CTU, filter and Container closure validation The ideal...

  • Validation Engineer

    3 weeks ago

    Carlow, Ireland Life Science Recruitment Ltd Full time

    11 month contract Validation Engineer On site Carlow AMC22979 We are currently hiring for a Validation Engineer role with a rapidly expanding biopharmaceutical manufacturer based in Carlow. In this role you will support various areas of validation on site including Sterilization, cleaning, isolators, CTU, filter and Container closure validation The ideal...

  • Validation Engineer

    3 weeks ago

    Carlow, Ireland Claran Consultants Ltd Full time

    Role Description We are excited to offer a fantastic Engineering Specialist (Validation) opportunity for candidates interested in a new challenge in a c GMP regulatory environment.The successful candidates will support several aspects of Validation.The roles available that will require experienced, energetic and committed engineers are in the following...

  • Validation Engineer

    4 weeks ago

    The Municipal District of Carlow, Ireland i-Pharm Consulting Full time

    Get AI-powered advice on this job and more exclusive features.Principal Consultant - Engineering and OperationsTitle: Senior Validation EngineerContract Duration: 12 MonthsLocation: County Waterford, IrelandAre you looking for a way to make a real impact? As a Senior Validation Engineer, you will play a key role in ensuring compliance within a cGMP-regulated...

  • Technical Engineer-Hybrid

    1 week ago

    Carlow, Ireland Psc Biotech Ltd Full time

    Job 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...

  • Senior CQ/ Validation Professional

    7 days ago

    Carlow, Ireland Psc Biotech Corporation Full time

    Job Summary:Psc Biotech Corporation seeks an experienced Senior CQ/ Validation Engineer to join our science, engineering, and commercialization team. The successful candidate will support the transition of the facility from construction and project phase to a fully operational facility delivering life-saving products to patients.Responsibilities and...

  • Senior Validation Engineer

    4 weeks ago

    The Municipal District of Carlow, Ireland Orion Group Full time

    Orion Group Life Sciences are currently recruiting a Senior Validation Engineer (Hybrid) on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11-Month contract with huge potential to extend.The successful candidate will support Cleaning Validation including Recovery/Cleanability studies.What you will...

  • Technical Engineer-Hybrid

    1 week ago

    Carlow, Ireland Psc Biotech Ltd Full time

    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 Regulatory...

  • Quality Assurance Engineer

    1 week ago

    Carlow, Ireland Psc Biotech Ltd Full time

    Succeed in a dynamic environment where you'll have the opportunity to work on complex validation projects, lead technical-related initiatives, and collaborate with cross-functional teams. As a Senior Validation Specialist at PSC Biotech Ltd, you'll be responsible for designing, authoring, reviewing, approving, and executing qualification and validation...

  • Senior Validation Consultant

    1 week ago

    Carlow, Ireland Psc Biotech Ltd Full time

    About PSC Biotech LtdPSC Biotech Ltd 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. We serve 350 clients in more than 23 countries worldwide.We provide cloud-based software solutions for quality management and regulatory inspections,...

  • Senior Validation Manager

    20 hours ago

    Carlow, Ireland beBee Careers Full time

    Company OverviewLife Science Consultants (LSC) are a leading provider of consulting services to the life sciences industry. With a strong focus on process engineering and validation, we help companies navigate the complex regulatory environment and ensure compliance with industry standards.Job DescriptionWe are seeking a highly skilled and experienced...

Senior Validation Engineer-Hybrid

2 weeks ago

Carlow, Ireland PSC Biotech Ltd Full time
Job 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 Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

 

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

 

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

 

Role Functions:
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.
  • May be required to perform other duties as assigned.
  • This is a hybrid role


Requirements

Skills Required:

  • 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.
  • Demonstratable 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 orientated 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

#LI-MC1

 



Requirements
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. Engagement with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities. Exception / Deviation Management and Change Control.