Find Secondary project Jobs

Sr. Validation Specialist
PCI Pharma Services —Stamullin, County Meath
- Full-time
Front End Specialist Launch Team
Ball Corporation —Waterford, County Waterford
- €62,300–€89,690 a year
- Data analysis skills
- English
- Computer skills
- Employee assistance program
- Life insurance
Quick apply
GMP Warehouse Operative
Catalyx —Dublin, County Dublin
- Full-time
- Heavy equipment operation
- Forklift
- Microsoft Office
Quick apply
Substation Technician
Reach Active Ltd —Mullingar, County Westmeath
- From €27.06 an hour
- Full-time
- Maintenance
- No degree
- Quality control
- Sick pay
Quick apply
6d
Electrical Design Engineer - Substations
Actavo —Cork, County Cork
- €55,000–€75,000 a year
- AutoCAD
- Electrical Engineering
- Employee assistance program
- Referral programme
13d
Pharma Distribution Specialist
Catalyx —Dublin, County Dublin
- Full-time
- Heavy equipment operation
- Forklift
- Microsoft Office
Quick apply
Construction Quality Manager
AtkinsRéalis —Dublin, County Dublin
- Full-time
- Hybrid work
- Supervising experience
- No degree
- Construction experience
6d
Process Task Force Leader - Group Technical Services
CRH Group Services Ltd. —Dublin, County Dublin
- Full-time
- Engineering
- In-person
- Manufacturing
Quick apply
Senior Specialist, Fund/Client Accounting
The Bank of New York Mellon Corporation —Dublin, County Dublin
- Full-time
- Bachelor's degree
- Accounting
6d
Senior Internal Auditor - Dublin
CRH Group Services Ltd. —Dublin, County Dublin
- Full-time
- Microsoft Excel
- Finance
- Analysis skills
Quick apply
1d
Associate Director, QC Bioassays & Vaccine Potency - Dundalk
MSD —Dundalk, County Louth
- Full-time
- Hybrid work
- Master's degree
- Bachelor's degree
- No degree
3d
Chef Manager
BaxterStorey IRL —County Meath
- €41,000 a year
- Full-time
- Culinary experience
- Communication skills
- Employee assistance program
- Life insurance
Quick apply
4d
Senior Scheduler
Turner & Townsend —Dublin, County Dublin
- Full-time
- Hybrid work
- Bachelor's degree
- Contracts
- Construction experience
- Annual leave
Quick apply
Incident Response Senior Analyst - Dublin
CRH Group Services Ltd. —Dublin, County Dublin
- Full-time
- Azure
- Research
- AWS
Quick apply
Senior Packaging Engineer
MSD —Leopardstown, County Dublin
- Full-time
- Hybrid work
- Engineering
- Analysis skills
- Project management
11d
Team Lead – Electrical Design Substations
TLI Group Ltd —Limerick, County Limerick
- AutoCAD
- Microsoft Office
- No degree
Validation Engineer (Shift Role)
Amgen —Dún Laoghaire, County Dublin
- €61,882.55–€83,723.45 a year
- Master's degree
- Bachelor's degree
- Communication skills
3d
Senior Electrical Engineer – Electrical Design Substations
TLI Group Ltd —Dublin, County Dublin
- AutoCAD
- Microsoft Office
- No degree
- Annual leave
- Employee assistance program
AVP - Loan Operations
Citco —County Dublin
- Full-time
- Analysis skills
- Leadership
10d
Clinical Nurse Specialist Medical Oncology - Limerick Cancer Centre
UPMC —Limerick, County Limerick
- €62,077.17–€76,158.63 a year
- Microsoft Powerpoint
- Microsoft Word
- Nursing
- Annual leave

I want to receive the latest job alerts for secondary project

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

secondary project jobs near

Clinical Nurse Specialist jobs in Limerick, County Limerick

Distribution Specialist jobs in Dublin, County Dublin

Senior Analyst jobs in Dublin, County Dublin

Senior Electrical Engineer jobs in Dublin, County Dublin

Shift Leader jobs in Dublin, County Dublin

Construction Manager jobs in Dublin, County Dublin

Senior Internal Auditor jobs in Dublin, County Dublin

Validation Engineer jobs in County Sligo

Renewable Energy Engineer jobs in Dublin, County Dublin

Validation Engineer jobs in Wexford, County Wexford

Validation Engineer jobs in Cork, County Cork

Process Engineer jobs in County Dublin

Senior Validation Engineer jobs in Dublin, County Dublin

R&d Engineer jobs in County Dublin

Clinical Nurse Specialist jobs in County Westmeath

Clinical Nurse Specialist jobs in Naas, County Kildare

Clinical Engineering jobs in Dublin, County Dublin

Nurse Advisor jobs in County Dublin

Clinical Nurse Specialist jobs in Dublin, County Dublin

Hybrid Quality Documentation Specialist jobs in Dublin, County Dublin

Sr. Validation Specialist

PCI Pharma Services -
Stamullin, County Meath

Apply Now

Job details

Full-time

Qualifications

Packaging

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.

Main purpose of job:

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

Main responsibilities:

Support the validation effort for all Strategic Projects on site.
Ensure all validation activities on site relating to Facility, Equipment and Processes meet the expectations of clients but more specifically meet regulatory requirements (HPRA/ FDA).
Prepare, review and or approval of qualification and/or validation documentation (VMPs, specifications, protocols, reports etc.) in relation to instrument, equipment, facilities (including cold stores), utilities, automated systems, manufacturing processes and cleaning processes including FAT, SAT, IQ, OQ, PQ phases in conjunction with program Quality representation.
Drive solutions, in conjunction with the appropriate department, to ensure customer related validation problems are communicated and corrective actions are in place and closed in a timely manner. Thorough investigation of Quality and Validation issues using Root Cause Analysis methodology and implementation of robust corrective and preventative actions to prevent recurrence. Support change controls as required.
Execute validation activities, with minimal supervision, in conjunction with Technical, Production and Engineering functions.
Ensure the strict implementation of validation procedures plus the timely and accurate completion of all validation documentation.
Supports the coordination & scheduling of packaging validation activities in alignment with planning & packaging functions.
Perform Periodic reviews, revalidations, and continued process verifications on a scheduled basis.
Support all Regulatory Inspections, Customer visits and Customer audits on validation related queries as required.

Must Have:

Min 3 years' Quality experience
Min 2 years' Validation experience
Equipment Qualification (IQ, OQ, PQ) – Hands on experience in protocol generations, execution, completion
Process Validation (PV) experience
New Product Introduction (NPI) - Generation, execution and close out of validation projects
Communication Customer/Internal stake holders/Suppliers
Experience with deviation, CAPA processes
Flexible and able to manage multiple priorities simultaneously
Periodic reviews

Desired:

Experience with packaging - secondary packaging / blister packaging and high speed / automated lines would be a distinctive advantage for this position.
Ability to present risk-based project validation strategy in a clear and concise manner to the Business Unit Planners, Customers and where required, to senior management
Decision Making: Identify and understand issues, problems and opportunities whilst providing a viable solution
Passion for Results: high energy, maturity, ability to work under pressure and deliver results; get things done (an action-oriented approach)
Cleaning Validation (CV)
Computer Systems Validation (CSV)
Temperature mapping
FAT, SAT

#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

secondary project jobs

Sr. Validation Specialist

Front End Specialist Launch Team

GMP Warehouse Operative

Substation Technician

Electrical Design Engineer - Substations

Pharma Distribution Specialist

Construction Quality Manager

Process Task Force Leader - Group Technical Services

Senior Specialist, Fund/Client Accounting

Senior Internal Auditor - Dublin

Associate Director, QC Bioassays & Vaccine Potency - Dundalk

Chef Manager

Senior Scheduler

Incident Response Senior Analyst - Dublin

Senior Packaging Engineer

Team Lead – Electrical Design Substations

Validation Engineer (Shift Role)

Senior Electrical Engineer – Electrical Design Substations

AVP - Loan Operations

Clinical Nurse Specialist Medical Oncology - Limerick Cancer Centre

I want to receive the latest job alerts for secondary project

Related Searches

Explore jobs in more locations

#LI-JP1

Jobseeker tools

Employer Tools

Browse

Stay Connected