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Validation Engineer

Employer
Sanofi Ireland
Location
Waterford
Salary
Negotiable
Closing date
1 Feb 2023

View more

Sector
Engineering
Job Type
Contract
Hours
Full-time

Job Details

Validation Engineer

Manpower has an exciting opportunity for a Validation Engineer with our Life Sciences client based in Waterford.

About the opportunity.
As a Validation Engineer you will be responsible for commissioning, qualification and validation activities for sterile filling line complying with Engineering and Validation lifecycle requirements including but not limited to FAT, SAT, DR, IV, OV, IQ, OQ and PQ activities for facilities, utilities, equipment, cleaning and sterilization.

The Validation Engineer has a key role in ensuring the on-going validation and compliance of existing and new equipment, systems and processes. The following activities will be included as part of your role:

Responsible for qualification and validation activities

  • Perform qualification and validation activities in a GMP manner aligning with site standards and industry expectations for a sterile manufacturing facility
  • Develop Validation plans as required for the projects
  • Write qualification/validation protocols, execute protocols and author reports. Resolve protocol non-conformances as per site procedure.
  • Present validation approach and study results to project peers and managers
  • Present and defend validation studies during regulatory inspections and internal audit.
  • Generate deviations, CAPAs, perform investigations and root cause analysis
  • Perform change control assessments
  • Perform SOP revision, review and approval
  • Complete all internal and external training


Requirements

  • Bachelor's degree in engineering/science and >5 years of relevant experience (e.g., engineering or quality role in a regulated environment, preferably GMP)
  • Strong interpersonal, organizational and technical skills. Capability to work both independently and in a team environment. Strong analytical and communication skills are required
  • Experience in Commissioning, Qualification and Validation

 

Preferred Qualifications:

  • Familiarity with applicable HPRA, US and EU regulatory requirements
  • Excellent technical writing and verbal communication skills
  • Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project and Visio
  • Knowledge of Validation Lifecycle Approach
  • Understanding of Validation using risk-based approach

Company

Sanofi Ireland has 800 people working every day to serve those with health needs in Ireland and around the world. Wherever the team members are based, they all share the values of Teamwork, Integrity, Courage and Respect and their  common purpose:  Empowering Life.

Their manufacturing campus in Waterford has more than 740 skilled people working across multiple products and platforms, supplying therapies to people in over 70 countries. Sanofi continue to expand, providing opportunities for people to join the team, and help us support their No1 stakeholders; the people we provide our medicines for. 

Their dedicated team based out of Dublin bring a broad range of treatments to people across Ireland. Amongst our treatments we have consumer healthcare, vaccines, and medicines for cardiovascular disease, diabetes, multiple sclerosis, thrombosis, rare diseases and atopic dermatitis.

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