Periodic Requalification Engineer

• Location: Waterford

About the job

At Sanofi, we're committed to providing the next-gen healthcare that patients and customers need.

In the Periodic Requalification Engineer role, you will be required to support new product introductions, equipment qualification and the site requalification program. The Periodic Requalification Engineer has a key role in ensuring the on-going validation and compliance of existing and new equipment, systems and processes at Sanofi Ireland. The following activities will be included as part of your role.

For more than 20 years, our Waterford team has continued to grow and diversify to serve patients around the world. Today, a team of almost 800 works together at a state-of-the-art biopharmaceutical and medical device campus. Recognized through multiple local and national awards, Sanofi Waterford offers flexible working and access to a world of opportunities to grow your career at one location. As well as attractive benefits, the team enjoy access to an onsite gym and medical Centre that underpin a strong commitment to health and wellbeing.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible.

• Designing, executing and reporting on PQ Performance Qualifications.
• Designing, executing and reporting on validation studies for equipment, systems and processes.
• Ensuring validation studies are managed in conjunction with all required Sanofi standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.).
• Providing technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation and depyrogenation.
• Ensuring that the validation status of equipment and systems are in compliance with cGMP at all times.
• Maintaining validation documentation through the validation lifecycle.
• Participation in external regulatory inspections.
• Support Site Change Control process.
• Support deviation investigations ensuring deviations are closed prior to product release.
• Ensure compliance to Good Manufacturing Practices (cGMP) at all times.

About you

• To excel in this role you will need to have:
• 3-5 years' experience working in a Healthcare manufacturing environment - ideally part of which would be in the pharmaceutical sector.
• Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering Chemical/Mech/Elec)
• Natural influencer and works well as part of a multifunctional team.
• Highly motivated and self-resilient.
• Adaptable and flexible as well as a pragmatically minded problem solver.
• Sees projects/tasks through to completion.
• Capable of troubleshooting validation issues associated with projects, process development etc.
• Competent technical knowledge of pharmaceutical plants.
• Previous validation/product development experience would be highly advantageous for the role.
• Knowledge of Process Validation regulations, current process validation and technical transfer industry practices, and experience of interpretation and application of guidelines and regulations.
• Knowledge of requirements for of GAMP, ISPE Baseline guides.
• Knowledge of steam and dry heat validation publications such as AAMI/ANSI, PDA and ISO guidelines.
• Full understanding of relevant quality and compliance regulations
• Able to execute projects to plan.
• Good knowledge of quality management systems.
• Good communication skills at organisation, team and individual levels.
• Ability to use MS Project and SPC packages an advantage
• Understands KPI's for the site.

Pursue Progress . Discover Extraordinary .

Progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let's pursue progress. And let's discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Visas for those who do not already have the right to work in the UK will be considered on a case by case basis according to business needs and resources.

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