Plant Process C&Q Validation Engineer New

3 weeks ago

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

  • Plant Process C&Q Validation Engineer

    2 days ago

    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...

  • Process Plant Cqv Engineer

    5 days ago

    Waterford, Ireland Tandem Project Management Ltd. Full time

    OverviewOur client is a biopharmaceutical company in Waterford looking for a Validation Engineer to to support a new project.The Validation Engineer has a key role in ensuring the on-going validation and compliance of new equipment, systems and processes.ResponsibilitiesExecuting FAT/SAT/IOQ protocols including generation of protocols and reports.Designing,...

  • Process Plant CQV Engineer 9/16/2025 A

    4 weeks ago

    Waterford, Waterford, Ireland Tandem Project Management Limited Full time

    Summary: Our client is a biopharmaceutical company in Waterford looking for a Validation Engineer to to support a new project. The Validation Engineer has a key role in ensuring the on-going validation and compliance of new equipment, systems and processes. Responsibilities: Executing FAT/SAT/IOQ protocols including generation of protocols and reports....

  • Validation Engineer

    1 week ago

    Waterford, Ireland Tandem Project Management Ltd. Full time

    Overview Our client is a global biopharma company based in Waterford looking for a Validation Engineer who will be required to support new product introductions, equipment qualification and the site requalification program. The Validation Engineer has a key role in ensuring the on-going validation and compliance of existing and new equipment, systems and...

  • Validation Engineer

    4 weeks ago

    Waterford, Waterford, Ireland Tandem Project Management Ltd. Full time

    SummaryOur client is a global biopharma company based in Waterford looking for a Validation Engineer who will be required to support new product introductions, equipment qualification and the site requalification program.The Validation Engineer has a key role in ensuring the on-going validation and compliance of existing and new equipment, systems and...

  • Validation Engineer

    1 week ago

    Waterford, Ireland Tandem Project Management Ltd. Full time

    OverviewOur client is a global biopharma company based in Waterford looking for a Validation Engineer who will be required to support new product introductions, equipment qualification and the site requalification program.The Validation Engineer has a key role in ensuring the on-going validation and compliance of existing and new equipment, systems and...

  • ▷ Only 24h Left: Validation Engineer

    1 week ago

    Waterford, Ireland Tandem Project Management Ltd. Full time

    Overview Our client is a global biopharma company based in Waterford looking for a Validation Engineer who will be required to support new product introductions, equipment qualification and the site requalification program. The Validation Engineer has a key role in ensuring the on-going validation and compliance of existing and new equipment, systems and...

  • Junior CSV Engineer New

    3 weeks ago

    Waterford, Ireland CPL Full time

    Company Profile: 12-month contract opportunity for a Junior CSV Engineer to join an employer who is consistently ranked as one of Irelands top workplaces that fosters collaborative and inclusive environment. If you have a background in writing validation protocols, reports, compliance documentation and are looking to get more practical knowledge in Computer...

  • Plant Manager

    2 weeks ago

    Waterford, Ireland Knowhirematch Full time

    Plant Manager – Clare, MI Compensation:$125,000–$150,000 base + Quarterly Bonus (10–20%) + 12% 401(k) Match + Full Benefits Position Overview: We are seeking an experiencedPlant Managerto lead operations at our Clare, MI facility. This role is responsible for all aspects of manufacturing—including production, quality, safety, maintenance,...

  • Validation Engineer

    7 days ago

    Waterford, Ireland Jabil Full time

    OverviewJabil Waterford, County Waterford, IrelandJoin to apply for theValidation Engineerrole atJabilJabil Waterford, County Waterford, Ireland6 days ago Be among the first 25 applicantsJoin to apply for theValidation Engineerrole atJabilResponsibilitiesThe validation engineer shall be responsible for creating and executing validation documentation and...