Validation Engineer

Recruiter
Grifols
Location
Dublin West, Dublin
Salary
Negotiable
Posted
19 Sep 2022
Closes
17 Oct 2022
Ref
Validation Engineer
Contact
Ann Marie Corcoran
Sector
Engineering
Job Type
Permanent
Hours
Full-time

Validation Engineer

Grifols a Global Healthcare Company in Grange Castle in Dublin 22 is recruiting for a Validation Engineer

Write, review and execute Validation Protocols and Reports for the new GWWO Albumin Purification and Aseptic Filling Plant ensuring compliance to all relevant global and local quality and validation procedures /standard. Initial requirements to focus on the areas of Equipment, Utilities, CSV and Cleanroom Validation. Minimum two years hands-on validation experience preferred.

 

RESPONSIBILITIES

  • Write, review and execute Validation Protocols and Reports for the new Albumin Plant (for Equipment, Utilities, Processes, Cleaning, Temperature Mapping and Equipment Software) ensuring compliance to all relevant global and local quality and validation procedures/standards
  • Review change controls and assess impact of changes that affect validated systems and define validation requirements
  • Represent Validation at both internal and external audits by regulatory agencies, including HPRA and FDA.
  • Generation and review of project documentation (User Requirement Specifications, validation protocols, reports etc.) and Standard Operating Procedures.
  • Supporting validation activities including review of documentation and hands-on execution of validation activities (FAT, SAT, IQ, OQ, PQ etc) to ensure equipment meets current GMP requirements and industry standards.
  • Maintain the Site Validation Master Plan (VMP) and associated Project VMP's, defining the validation approach associated with each piece of equipment, system, process and the requalification requirements including study requirements and frequency. Execute/Co-ordinate Re-Validation activities as required.
  • Completion of risk assessments, closure of corrective and preventive actions.
  • Investigates and troubleshoots problems and determines solutions or recommendations for changes and/or improvements.
  • Performs other validation associated activities as defined by Manager or Director.
  • Computer System Validation
  • Clean Utilities
  • Calibration
  • Autoclave / Thermal Mapping
  • Process and Cleaning Validation
  • Commissioning and Qualification
  • Documentation (Writing SOPs, Protocols, Reports)
  • Clean Room Qualification
  • Auditing

 

REQUIREMENTS

  • Strong communication / presentation skills during internal/external audits
  • Hands-on knowledge of execution of Validation
  • Experience in a Quality or Validation Role within Pharma sector
  • Experience with Software validation for manufacturing
  • Excellent Technical Writing and analytical skills.
  • Familiarity with cGMPs and industry and federal guidelines required.
  • Experience with Word, Excel and Access computer applications.
  • Strong interpersonal skills for interactions with other departments.
  • Degree in Science/Engineering
  • Experience in representing client companies during internal (Corporate) audits and external (FDA and HPRA) audits an advantage
  • Working knowledge of HTM 01 (Part C, Steam Sterilization) Autoclaves an advantage
  • Familiarity with ISO-14644 (Cleanrooms and Associated Environments) an advantage
  • Familiarity with Annex 1 (Manufacture of Sterile Medicinal Products) an advantage
  • Experience within aseptic manufacturing environment an advantage

Apply for Validation Engineer

Already uploaded your CV? Sign in to apply instantly

Apply

Upload from your computer

Or import from cloud storage

Your CV must be a .doc, .pdf, .docx, .rtf, and no bigger than 1MB


4000 characters left

Marketing Communication

We would like to send you electronic communications regarding employment related opportunities, services and information that we consider suitable for you.

I would like to receive communications.

I would like you to share my personal data with other Companies within the ManpowerGroup.

You will receive an email containing the responses you have provided today with a link that will allow you to update your consent preferences at any time in the future. You can view a list of ManpowerGroup companies by clicking here.


When you apply for a job we will send your application to the named recruiter, who may contact you. By applying for a job listed on manpower.ie you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us.

More searches like this