Plant Process C&Q Validation Engineer New

1 week ago

Waterford, Waterford, Ireland CPL Full time
We're seeking a skilled Validation Engineer to join a leading global biopharmaceutical company. In this role, you will be responsible for ensuring that systems, equipment, and processes meet regulatory standards and operate reliably throughout their lifecycle. You'll collaborate cross-functionally with Quality, Engineering, and Manufacturing teams to support validation activities in a GMP-compliant environment.

Key Responsibilities:

The following activities will be included as part of your role:

• Executing FAT/SAT/IOQ protocols including generation of protocols and reports.

• 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

Education, Skills & Qualifications:

• Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering Chemical/Mech/Elec)

• 3-5 years' experience working in a Healthcare manufacturing environment – ideally part of which would be in the pharmaceutical sector.

• 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.

• Previous Equipment knowledge for example pack lines, Autoclaves, Isolator Technology and fill lines would be an advantage.

#LI-AG2

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