Find Engineering team Jobs in Dunleer, Lh

Validation Specialist
PCI Pharma Services —Stamullin, County Meath
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Manufacturing Materials Specialist
WuXi Biologics —Dundalk, County Louth
- Doctoral degree
- Master's degree
- Presentation skills
14d
Senior Mechanical Engineer
Irish Cement Ltd. —Louth, County Louth
- Full-time
- AutoCAD
- Microsoft Office
- No degree
Quick apply
Senior OpEx Specialist
WuXi Biologics —Dundalk, County Louth
- Engineering
- Master's degree
- Bachelor's degree
Learning and Development Manager
Alternative Heat —Dundalk, County Louth
- Full-time
- No degree
- Leadership
Quick apply
Associate Director Validation
PCI Pharma Services —Stamullin, County Meath
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Senior Electrical Buyer/Lead
Suretank —Dundalk, County Louth
- Full-time
- Microsoft Excel
- ERP systems
- Data analysis skills
- Free parking
- Employee assistance program
Quick apply
5d
Global Principal Packaging Engineer
PCI Pharma Services —Stamullin, County Meath
- Overtime
- Engineering
- Master's degree
- Assembly
Project Coordinator
Glanua —Dundalk, County Louth
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
- Annual leave
- Employee assistance program
Quick apply
6d
Mechanical Project Engineer
Glanua —Dundalk, County Louth
- Full-time
- Communication skills
- Mechanical knowledge
- Negotiation
- Annual leave
- Employee assistance program
Quick apply
6d
CNC Programmer - Swiss Lathe
Gus Precision Engineering Services —Dundalk, County Louth
- €46,000–€55,000 a year
- Manufacturing
- Sick pay
Quick apply
3d
Junior Quantity Surveyor
EPS Group —Drogheda, County Louth
- Full-time
- English
- Bachelor's degree
- IT
Quick apply
Manufacturing Systems Specialist
WuXi Biologics —Dundalk, County Louth
- Doctoral degree
- Master's degree
- Presentation skills
14d
Graduate Engineer - Drogheda
EPS Group —Drogheda, County Louth
- Full-time
- AutoCAD
- Engineering
- Bachelor's degree
Quick apply
8d
Stores Person/Van Driver
MTM Engineering —Slane, County Meath
- Full-time
- Microsoft Word
- Microsoft Excel
- Microsoft Office
Quick apply
Project Engineer
PCI Pharma Services —Stamullin, County Meath
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Project Planner
MTM Engineering —Slane, County Meath
- Full-time
- Analysis skills
- Electrical Engineering
- Communication skills
Quick apply
Process Technician Serialisation
PCI Pharma Services —Stamullin, County Meath
- Full-time
- Software troubleshooting
- Communication skills
Manager, Application Analysis Team
Prometric —Dundalk, County Louth
- Full-time
- Azure
- Computer Science
- Analysis skills
- Annual leave
- Employee assistance program
Quick apply
IRE_NPI Project Manager
PCI Pharma Services —Stamullin, County Meath
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
10d

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Validation Specialist

PCI Pharma Services -
Stamullin, County Meath

Apply Now

Job details

Full-time

Qualifications

Microsoft Powerpoint
Microsoft Word
Microsoft Excel
Lean
Microsoft Office
Bachelor's degree
Manufacturing
Lean manufacturing

Full job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

We are looking for a Validation Specialist (Permanent role) to join our team in Stamullen, County Meath. This is a Monday to Friday position, 100% on-site.

Summary of Role:

The role of the Validation Specialist is to implement and execute tasks relating to Process, Facility and Equipment Development at PCI Pharma Services sites.

Areas of validation included are:

Process Validation (PV)

Cleaning Validation (CV)

Computer Systems Validation (CSV)

Key Responsibilities:

Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department
Ensuring all validation activities on site relating to Facility, Equipment and Processes meet the expectations of clients but more specifically meet regulatory requirements (HPRA/ FDA).
Comply with Site Validation Master Plan.
Generate validation protocols for new and existing computer systems, facilities, equipment and processes and review/approve all reports. Also to generate and maintain documentation for cleaning validation performed at PCI sites in Ireland.
Execute validation activities, with minimal supervision, in conjunction with Technical, Production and Engineering functions.
Perform sampling in support of validation studies, including AQL, and cleaning validation.
Manage tooling validations and associated documentation.
Ensure the strict implementation of validation procedures plus the timely and accurate completion of all validation documentation.
Support complaint investigations, deviation investigations and change controls as required.
To undertake such tasks and to manage specific or ad hoc projects as and when required to meet business needs and within the scope of the job-holder’s capabilities.
Identify and support opportunities for improving processes and or procedures.
Perform Periodic reviews and revalidations on a scheduled basis.
Work with Validation team to ensure a robust and compliant validation system is in place.
Ensure validation being performed is in line with industry standards and latest regulatory guidelines.
Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.

Essential:

Bachelor’s or associate degree or Diploma / Certificate in Quality / Validation. May substitute experience in lieu of educational requirements.
Minimum 2 years’ experience working in Manufacturing or Quality.
Demonstrate interest in Validation.
Capability to follow clear goals, communicate clearly and ensure progress to completion meeting predefined targets.
Ability to manage multiple tasks and set priorities.
Problem Solving and Troubleshooting skills. The successful candidate should display a dynamic and proactive approach to manage problems.
Self-motivated with a results driven approach.
Flexibility to work across different shifts on request in line with business needs.
Adaptable and ability to work collaboratively.
Proficient in Microsoft Office products (incl. Excel, PowerPoint, Word, etc.).
Experience in a GMP or Regulated Environment.

Desirable:

Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.

#LI-JP1

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Apply Now

Refine Your Search

engineering team jobs in dunleer, lh

Validation Specialist

Manufacturing Materials Specialist

Senior Mechanical Engineer

Senior OpEx Specialist

Learning and Development Manager

Associate Director Validation

Senior Electrical Buyer/Lead

Global Principal Packaging Engineer

Project Coordinator

Mechanical Project Engineer

CNC Programmer - Swiss Lathe

Junior Quantity Surveyor

Manufacturing Systems Specialist

Graduate Engineer - Drogheda

Stores Person/Van Driver

Project Engineer

Project Planner

Process Technician Serialisation

Manager, Application Analysis Team

IRE_NPI Project Manager

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