Process Validation Expert

7 days ago


Cork, Cork, Ireland beBee Careers Full time
Process Validation Engineer

This is an exciting opportunity to work in a state-of-the-art facility.

  • Perform process validation activities related to drug substance and drug products, through defined clinical and commercial stages.
  • Execute process validation activities related to the implementation of process changes and new processes while exercising supervised judgement within broadly defined procedures and practices to establish acceptance criteria, and to identify and implement solutions to meet Health Authority requirements.

Responsibilities:

  1. Develop, execute and finalise process validation protocols for Client's drug substance and drug products.
  2. Assist with preparation of regulatory filings, with answering questions from regulatory agencies, and with presentations of materials during regulatory inspections/partner audits.
  3. Determine methods and procedures on new assignments with supervision and in accordance with developed practices and procedures.

Requirements:

  • Experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in process validation, process sciences and change control.
  • Ability to communicate with, present data to, and defend approaches in front of variable hierarchical audiences, scientific disciplines and health authority reviewers/inspectors.
  • Understanding and demonstrated knowledge of regulatory requirements, guidelines, and recommendations for process validation expectations.

  • Validation Expert

    2 weeks ago


    Cork, Cork, Ireland beBee Careers Full time

    Validation Expert RoleWe are looking for a skilled and dedicated individual to take on the role of Validation Expert. This is an exciting opportunity for someone to develop their validation knowledge and skills while contributing to business objectives.In this role, you will work collaboratively with the manufacturing and process engineering teams to ensure...


  • Cork, Cork, Ireland beBee Careers Full time

    As a Validation Engineer, you will design, execute, and report on process validation (PV) and process performance qualifications (PPQ). You will also perform validation studies for equipment, systems, and processes, ensuring compliance with cGMP, health & safety, and regulatory requirements.


  • Cork, Cork, Ireland beBee Careers Full time

    Process Validation EngineerThis is a fantastic opportunity to work in a state-of-the-art facility.You will be responsible for performing process validation activities related to drug substances and drug products.Perform process validation activities through defined clinical and commercial stages.Execute protocol generation, execution, and final package...


  • Cork, Cork, Ireland beBee Careers Full time

    Critical Validation Expert RequiredWe are seeking an experienced Critical Validation Expert to join our team. The successful candidate will lead and execute validation activities for medical devices, ensuring full compliance with regulatory standards and quality system requirements.Responsibilities:Execute process and software validation activities in a...

  • Validation Expert

    7 days ago


    Cork, Cork, Ireland beBee Careers Full time

    Job Title: Process Validation EngineerJob Summary:A rewarding opportunity for a skilled Process Validation Engineer to join our team in a state-of-the-art facility. About the Role:This position involves performing process validation activities related to drug substance and drug products through clinical and commercial stages. Responsibilities include...


  • Cork, Cork, Ireland beBee Careers Full time

    Cleanliness Validation ExpertWe have an exciting opportunity for a Cleanliness Validation Expert to contribute to the development and commercialisation of innovative medicines. This role is ideal for individuals who are passionate about ensuring the highest standards of cleanliness in pharmaceutical production.About the Role:The primary responsibility of...


  • Cork, Cork, Ireland beBee Careers Full time

    Validation ExpertWe are seeking a highly skilled Validation Expert to join our team. As a senior member of our engineering team, you will play a key role in ensuring the quality and reliability of our software products. You will develop and implement validation strategies, collaborate with cross-functional teams, and execute end-to-end validation...


  • Cork, Cork, Ireland TN Ireland Full time

    Job DescriptionPROCESS AND VALIDATION SCIENTIST with an understanding of key TS/MS deliverables such as Tech Transfer, Process Monitoring, Process Validation, On-going Process Verification and Annual Product Reviews required by CareerWise Recruitment for our multinational Biotechnology client in Co. Cork, this is a permanent role. The PROCESS AND VALIDATION...


  • Cork, Cork, Ireland CareerWise Recruitment Full time

    Job Description PROCESS AND VALIDATION SCIENTIST with an understanding of key TS/MS deliverables such as Tech Transfer, Process Monitoring, Process Validation, On-going Process Verification and Annual Product Reviews required by CareerWise Recruitment for our multinational Biotechnology client in Co. Cork, this is a permanent role. The PROCESS AND...


  • Cork, Cork, Ireland beBee Careers Full time

    Validation Expert WantedA qualified individual is needed to work in a team to validate medical devices, adhering to industry standards and company policies.Key Job FunctionsExecute process and software validation tasks according to established procedures.Develop, implement, and maintain validation protocols and documentation.Provide expert guidance on...