Validation Expert

2 weeks ago

Cork, Cork, Ireland beBeeQuality Full time
Job Title: Quality Control and Validation Lead

About the Role:

We are seeking an experienced Quality Control and Validation Lead to join our team. This is a critical role that requires strong leadership, technical expertise, and excellent communication skills.

  • The successful candidate will be responsible for leading and coordinating CQV projects, ensuring timely execution and compliance with industry regulations.
  • They will work closely with cross-functional teams, including process engineering, quality operations, and logistics, to develop and execute the optimum validation strategy.
  • The candidate will manage and coordinate equipment qualification activities, including factory acceptance testing, site acceptance testing, installation-qualification, operational qualification, and performance qualification.
  • They will also be responsible for managing project plans, schedules, and budgets to ensure alignment with business objectives.

Key Responsibilities:

  • Lead and coordinate CQV projects from start to finish, ensuring timely delivery and compliance with regulatory requirements.
  • Develop and maintain project plans, schedules, and budgets to ensure alignment with business objectives.
  • Manage and coordinate equipment qualification activities, including factory acceptance testing, site acceptance testing, installation-qualification, operational qualification, and performance qualification.
  • Work closely with cross-functional teams to develop and execute the optimum validation strategy.
  • Provide leadership in team meetings and facilitate problem-solving discussions to ensure project milestones are met.

Requirements:

  • Experience in deployment and/or extensive working knowledge/experience of a digitized C&Q platform.
  • Clear understanding and previous experience in deployment and execution of a Risk-Based Validation (RBV) process in line with ISPE guidelines.
  • Experience of managing teams or projects in a fast-paced and complex environment.
  • Relevant qualification (Degree) and/or relevant experience of 10+ years in the biotech/pharmaceutical industry qualifying GXP systems.

What We Offer:

  • A competitive salary and benefits package.
  • Ongoing training and development opportunities.
  • The chance to work on exciting and challenging projects.

How to Apply:

If you are a motivated and experienced professional looking for a new challenge, please submit your application, including your resume and cover letter.

  • Validation Expert

    1 week ago

    Cork, Cork, Ireland beBeeValidation Full time

    Validation Engineer PositionWe are seeking an experienced validation engineer to join our team and support a high-impact project with a global biologics client.This is a fantastic opportunity to work with cutting-edge equipment, systems, and processes in a cGMP environment and contribute to critical validation lifecycle activities.Key Responsibilities:

  • Validation and Verification Expert

    2 days ago

    Cork, Cork, Ireland beBeeExpert Full time

    Job DescriptionContribute to Breakthroughs in Battery Management SystemsWe are seeking a skilled Validation Engineer to join our team of innovators. In this role, you will be responsible for developing and executing validation strategies to ensure the performance, reliability, and compliance of our wired and wireless BMS tools.Key Responsibilities:Develop...

  • Expert Process Validator

    1 week ago

    Cork, Cork, Ireland beBeeQualification Full time

    Job Summary:As a Qualification and Validation Specialist, you will be responsible for ensuring that our facilities, equipment, and supporting systems meet the highest quality standards. You will play a critical role in defining and implementing procedures and processes to guarantee compliance with regulatory requirements.Key Responsibilities:Quality...

  • Automation Systems Validation Expert

    1 week ago

    Cork, Cork, Ireland beBeeValidation Full time

    Job OverviewWe are seeking an Automation Specialist to join our team. The ideal candidate will have hands-on experience in equipment qualification and computerized system validation.About the RoleThis is a mid-senior level full-time position that involves driving qualification and validation activities for automation and computerized systems.The successful...

  • Validation Expert for Pharmaceutical Projects

    3 days ago

    Cork, Cork, Ireland beBeevalidation Full time

    Job Title: Validation SpecialistQA Resources is seeking contract Validation Specialists for an exciting project in Cork. Key Responsibilities:Review and report on IQ/OQ/PQ protocols and reports for software, equipment, and facilities.Develop validation protocols and reports to ensure compliance with regulatory requirements.Assist in managing the site...

  • Eirdata Validation Manager

    1 week ago

    Cork, Cork, Ireland ESS Ltd. Full time

    Who we are: Established in 2001, Eirdata are specialists in cleanroom validation, commissioning & compliance.We provide these range of services to the pharmaceutical, medical devices and healthcare sectors primarily.In 2013, Eirdata was acquired by ESS Ltd.Engineering, Support & Services (ESS) Ltd We work with our people to implement and carry out...

  • QA Validation Specialist

    1 week ago

    Cork, Cork, Ireland PE Global Full time

    The role:PE Global is currently recruiting for numerous QA Validation Specialists on behalf of a leading API company in Cork. These are all initial 12-24 month contract roles.Responsibilities:Maintenance of a strong Quality culture throughout the project through operational activities.Provide QA support for risk based verification activities in the capacity...

  • Leading Computer Systems Validation Expert

    1 week ago

    Cork, Cork, Ireland beBeeAutomation Full time

    We are seeking a seasoned Computer Systems Validation Engineer to join our team. In this role, you will be responsible for managing the qualification of GxP computerized systems involved in plant expansion and improvement projects.Key Responsibilities:Design, commissioning, qualification, and validation documentation – drafting, reviewing, and approving...

  • System Validation Engineer

    6 days ago

    Cork, Cork, Ireland Independent Solutions Full time

    2 days ago Be among the first 25 applicantsDirect message the job poster from Independent SolutionsSenior Talent Acquisition Specialist at Independent Solution | Hiring for Pharma & Biotech | Expert in Global SourcingJob Opportunity – CSv & Laboratory IT Analyst (Contract)Location: Limerick, Ireland (On-site)Contract Type: 12-month (extendable)Start Date:...

  • System Hardware Validation Engineer

    3 weeks ago

    Cork, Cork, Ireland Qualcomm Full time

    Company:QT Technologies Ireland LimitedJob Area:Engineering Group, Engineering Group > ASICS EngineeringGeneral Summary:About The RoleThe System Hardware Validation Engineer will work as part of Qualcomm's SVE (System Validation Emulation) Team on leading technologies such as the Qualcomm Snapdragon chipset. SVE have a critical impact on getting high quality...