Current jobs related to Senior Validation Engineer - Dublin, Dublin City - Orion Group

  • Senior Validation Engineer

    4 days ago

    Dublin, Dublin City, Ireland beBeeComputerSystemValidation Full time €60,000 - €80,000

    Job Title: Senior Validation EngineerOverview of the RoleWe are seeking a highly skilled and experienced Senior Validation Engineer to join our team. This is an exciting opportunity for someone who is passionate about validation and quality assurance.The successful candidate will be responsible for designing, implementing, and managing validation processes...

  • Senior Validation Engineer

    2 weeks ago

    Dublin, Dublin City, Ireland Orion Group Full time

    Orion Group Life Sciences are currently recruiting a Senior Validation Engineer on behalf of our Multinational Biopharmaceutical Client based in Carlow on an 11-month contract with potential to extend.Role DescriptionAn exciting opportunity is available for a Senior Engineering Specialist (Validation) within a cGMP regulatory environment. The successful...

  • Validation Engineer

    3 weeks ago

    Dublin, Dublin City, Ireland DPS Group Global Full time

    Get AI-powered advice on this job and more exclusive features.Sign in to access AI-powered advicesContinue with Google Continue with GoogleContinue with Google Continue with GoogleContinue with Google Continue with GoogleContinue with Google Continue with GoogleContinue with Google Continue with GoogleContinue with Google Continue with GoogleDirect message...

  • Senior Validation Engineer

    4 weeks ago

    Dublin, Dublin City, Ireland MatchSTEM Full time

    This is an exciting opportunity for a fantastic Senior Engineering Specialist for candidates interested in a new challenge in a cGMP regulatory environment. The successful candidate will support Cleaning Validation including Recovery/Cleanability studies.Role FunctionsBring energy, knowledge, innovation to carry out the...

  • Senior Validation Engineer

    1 week ago

    Dublin, Dublin City, Ireland beBeeSterilization Full time €90,000 - €140,000

    Job Opportunity">">A new and exciting Validation Role has come for a Senior Engineering Specialist on our Carlow Site with Technical Operations. You will be responsible for:">Leading validation activities within the Sterilisation qualification team and across other validation teams.">Maintaining compliance of Global Policies, Procedures and Guidelines,...

  • Senior Validation

    2 weeks ago

    Dublin, Dublin City, Ireland embecta Full time

    Senior Validation & Verification EngineerSenior Validation & Verification EngineerApply locations IRL Dun Laoghaire time type Full time posted on Posted 2 Days Ago job requisition id R21-00606513embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through...

  • Senior Validation Engineer

    2 weeks ago

    Dublin, Dublin City, Ireland Team Horizon Full time

    Team Horizon is seeking a Validation Engineers for a leading pharmaceutical company in South Dublin.Why you should apply: * This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses. * There is a...

  • Senior Validation Engineer Position

    1 week ago

    Dublin, Dublin City, Ireland beBeeValidation Full time €85,000 - €110,000

    Job Title: Senior Validation EngineerLocation: {location}, {country_code}.Benefits: Competitive salary, Share options, Pension, Healthcare , Annual bonus + excellent opportunity to develop your experience and career in an exciting company.Overview:In this role you will oversee and manage the validation and Advanced Product Quality Planning (APQP) lifecycle...

  • Validation Engineer

    4 weeks ago

    Dublin, Dublin City, Ireland Orion Group Full time

    1 day ago Be among the first 25 applicantsDirect message the job poster from Orion GroupOrion Group Life Sciences are currently recruiting a Validation Engineer (Isolator) on behalf of our Multinational Biopharmaceutical Client based in Carlow on an 11-month contract with potential to extend.Role DescriptionAn exciting opportunity is available for an...

  • Senior Process Engineering and Cleaning Validation Engineer

    3 weeks ago

    Dublin, Dublin City, Ireland WuXi Biologics Group Full time

    Senior Process Engineering and Cleaning Validation EngineerIreland Posted 2025-06-05As a Senior Cleaning Validation Engineer, you will support and lead the cleaning validation activities for the cGMP manufacture of biological bulk drug substance (BDS) at WuXi Biologics facility in Louth. The Cleaning Validation Engineer will validate/qualify cleaning...

Senior Validation Engineer

1 month ago

Dublin, Dublin City, Ireland Orion Group Full time

2 days ago Be among the first 25 applicants

Direct message the job poster from Orion Group

Orion Group Life Sciences are currently recruiting a Senior Validation Engineer on behalf of our Multinational Biopharmaceutical Client based in Carlow on an 11-month contract with potential to extend.

Role Description

An exciting opportunity is available for a Senior Engineering Specialist (Validation) within a cGMP regulatory environment. The successful candidate will support Cleaning Validation activities, including Recovery and Cleanability studies.

Role Functions

(Functions include, but are not limited to, the following)

What you will do:

Bring energy, knowledge, and innovation to carry out the following:

  • Design/Author/Review/Approve/Execute qualification and validation documentation and cycle development studies in line with the standard approval process.
  • Design/Author/Review/Approve/Execute development and execution of change controls.
  • Resolve technical issues encountered during study execution.
  • Engage with Production, Maintenance, and Quality representatives during execution of Cycle Development and Performance Qualification activities.
  • Provide technical input into quality notifications by authoring/reviewing/approving investigations.
  • Perform root cause analysis of system failures or substandard performance using standard tools and methods to resolve equipment and system issues.
  • Support continuous improvement initiatives through Lean Six Sigma methodologies.
  • Serve as a validation representative for cross-functional projects and represent the validation function in global technical forums.
  • Drive compliance with Global Policies, Procedures, Guidelines, and regulatory requirements; execute current Good Manufacturing Practices (cGMP) in all job functions, ensuring awareness of impact on GMP and compliance.
  • Maintain accountability for compliance through documentation, risk assessments, corrective actions, audit and inspection participation, and proactive compliance issue resolution.
  • Support regulatory audits and submissions as required.
  • Contribute to a culture focused on safety and compliance.
  • Perform additional duties as assigned.

Experience, Knowledge & Skills

What skills you will need:

To excel in this role, the following experience and capabilities are typically required:

  • Experience in cleaning validation, including CD and PQ of mobile vessels (CIP) and parts washers (COP), recipe development and optimization, cleaning verification, cleanability and recovery studies using TOC, ICP, and swab methods, determination of acceptable residual limits, worst-case soil matrices, and strategy development.
  • Significant experience in a similar role within a GMP manufacturing environment, demonstrating individual contribution to business outcomes.
  • Relevant technical qualification(s) in Applied Pharmaceutical, Biological, Chemical Sciences, or an Applied Technical/Engineering discipline.
  • Experience in Exception/Deviation Management and Change Control.
  • Demonstrated ability to lead technical projects.
  • Familiarity with process monitoring systems, automation systems (e.g., DeltaV), operational intelligence and data systems (e.g., Pi System) within a GMP environment is desirable.
  • Evidence of continuous professional development is preferred.
  • Knowledge of relevant regulatory requirements and standards (Irish, European, and International).
  • Strong analytical skills, with the ability to interpret complex data and link findings to equipment performance and investigation outcomes.
  • Proficiency in writing reports, standards, and policies.
  • Experience in equipment and process validation.
  • Familiarity with Sterile Fill-Finish processes and equipment.
  • Proficiency in Microsoft Office and job-related applications.
  • Excellent communication, presentation, and interpersonal skills to work effectively with internal teams and external stakeholders.

Additional knowledge and experience in the following areas is advantageous:

  • Filter Validation
  • Container Closure Integrity (CCI) Qualification
  • Shipping Qualification
  • Periodic Equipment Validation
  • Equipment Validation Lifecycle
  • Project Management (experience or qualification)
  • Isolator VHP/HVAC Qualification
  • Controlled Temperature Units/Equipment Qualification
  • Vial and Syringe Processing Technologies

Qualifications & Education

  • Relevant technical qualification(s) in Applied Pharmaceutical, Biological, or Chemical Sciences, or in an Applied Technical/Engineering field.
Seniority level
  • Seniority levelMid-Senior level
Employment type
  • Employment typeContract
Job function
  • IndustriesPharmaceutical Manufacturing

Referrals increase your chances of interviewing at Orion Group by 2x

Sign in to set job alerts for "Validation Engineer" roles.

Carlow, County Carlow, Ireland 2 days ago

Carlow, County Carlow, Ireland 2 weeks ago

Carlow, County Carlow, Ireland 2 weeks ago

Carlow, County Carlow, Ireland 1 week ago

Carlow, County Carlow, Ireland 2 weeks ago

Carlow, County Carlow, Ireland 2 days ago

Carlow, County Carlow, Ireland 1 week ago

Carlow, County Carlow, Ireland 1 week ago

Carlow, County Carlow, Ireland 5 days ago

Carlow, County Carlow, Ireland 2 days ago

Carlow, County Carlow, Ireland 2 days ago

Carlow, County Carlow, Ireland 15 hours ago

Carlow, County Carlow, Ireland 3 weeks ago

We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr