Validation Engineer
4 weeks ago
Social network you want to login/join with:
At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?
There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.
We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.
POSITION SUMMARY:Provide continuity for the validation program for assigned plant or functional area by writing, reviewing and approving validation documentation. Other duties may be assigned.
ACCOUNTABILITIES:- Responsible for assuring compliance to West Pharmaceutical Systems validation program.
- Ensure that the validation requirements are documented to provide direction for meeting the validation needs of the customers, regulatory bodies, manufacturing plants, research & development, IT and laboratory groups.
- Provide guidance to system/process stakeholders for validation documents, as to content and format of validation life cycle documentation.
- Write protocols and reports directly related to QA, e.g. (statistical sampling plans, assessment criteria (Validation Rationale), compliance, guidelines, specifications, etc.).
- Review and approve validation life cycle documentation, including change control documents, specifications, protocols, deviations, and reports.
- Provide guidance during protocol incident process, including reporting, investigations and approval of resolutions.
- Utilize engineering, vendor, and customer specifications to generate and execute testing protocols for equipment following West and customer procedures and good documentation practices.
- Strong attention to detail and knowledge of pharmaceutical processes and protocol around automation processes, equipment, and systems.
- Keep current with the industry standard practices and FDA requirements for validation.
- Write/revise validation templates and validation plans.
- Meet agreed to project deadlines.
Education: Minimum Bachelor of Science Degree in Engineering or Science.
Experience: Minimum 3-5 years of experience writing, approving and executing validation protocols and reports, specifically in the following areas: Process Validation, Sterilization, Equipment/Utility Qualification and Computer System Validation. Ability to comprehend computer systems applications and business/manufacturing processes. Excellent written and verbal communication skills, good problem solving skills, and ability to function as a team member and leader.
#J-18808-Ljbffr-
Validation Engineer
5 days ago
Dublin, Dublin City, Ireland Validation Associates Llc Full timeThe ultimate purpose of technology teams in GxP environments is to serve the evolving needs of the business.We are a specialist provider of consultancy and implementation services for IT infrastructure and data architectures within life science manufacturing.Our role is to be a companion on the road for technology teams to be able to use as a tool at times...
-
Validation Engineer
4 weeks ago
Dublin, Dublin City, Ireland VALIDATION ASSOCIATES LLC Full timeThe ultimate purpose of technology teams in GxP environments is to serve the evolving needs of the business. We are a specialist provider of consultancy and implementation services for IT infrastructure and data architectures within life science manufacturing. Our role is to be a companion on the road for technology teams to be able to use as a tool at times...
-
IT Validation Engineer
3 days ago
Dublin, Dublin City, Ireland VALIDATION ASSOCIATES LLC Full timeWelcome to Oleson's Technology Strategy & Transformation PracticeWe are uniquely focused on IT/OT systems in manufacturing operations with a particular strength in regulated life sciences manufacturing. Our strength lies in taking a full system view and understanding the complex relationships between manufacturing operations, business continuity, IT...
-
GxP Validation Specialist
5 days ago
Dublin, Dublin City, Ireland Validation Associates Llc Full timeThe role of a Validation Engineer is pivotal in ensuring the seamless integration and operation of technology systems within GxP environments.At Validation Associates LLC, we are seeking a talented professional to join our team as a Validation Engineer.This position offers an exceptional opportunity to work with our blue-chip multinational clients within the...
-
Validation Engineer
1 day ago
Dublin, Dublin City, Ireland Mason Alexander Full timeWe are delighted to partner with a well-known and established pharmaceutical company based in Wicklow, on a permanent Validation Engineer.This is a great role that would see you work as part of a wider Quality & Regulatory function, with a focus on performing and executing the validation and qualification duties for all projects across the site.As Validation...
-
Validation Engineer
6 days ago
Dublin, Dublin City, Ireland Team Horizon Full timeTeam Horizon is seeking an experienced Validation Engineer to support a new syringe filling line project at our client's manufacturing facility in Dublin.Why you should apply: This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients globally.What...
-
Validation Engineer
3 weeks ago
Dublin, Dublin City, Ireland Uniphar Group Full timeThis role will be based in our Uniphar Supply Chain and Retail division and will be based out of our Citywest Head office.Who Are We Looking For:Are you an experience validation engineer interested in working in a dynamic and strategic engineering team? Do you want exposure to opportunities within one of Irelands most successful PLCs?As a Validation...
-
Validation Engineer
1 day ago
Dublin, Dublin City, Ireland Orion Engineering Services Limited Full timeOrion Group Life Sciences are currently recruiting a Validation Engineer on behalf of our Multinational Biopharmaceutical Client on an initial 11-Month contract with potential to extend.Candidates must be flexible to be available to work shifts as may be required (2 Cycle 5 days a week: 7am-3pm and 3pm-11pm) 20% Shift Allowance.The successful candidates will...
-
Validation Engineer
3 weeks ago
Dublin, Dublin City, Ireland West Pharmaceutical Services Full timeAt West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and...
-
Validation Engineer
6 days ago
Dublin, Ireland West Pharmaceutical Services Full timeAt West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and...
-
Engineering Validation Consultant
1 day ago
Dublin, Dublin City, Ireland Mason Alexander Full timeMason Alexander is seeking a skilled Validation Engineer to join their Quality & Regulatory team on a permanent basis in Wicklow.This is a fantastic opportunity to work closely with our team, focusing on performing and executing validation and qualification duties for all projects across the site.Key responsibilities as a Validation Engineer...
-
Validation Engineer
5 days ago
Dublin, Dublin City, Ireland Cpl Healthcare Full timeOn behalf of our client, a global medical devices company, we are currently recruiting for a Validation Engineer.This is a permanent, full-site position based in North Wicklow/South Dublin.Reports to Maintenance, Engineering and Validation ManagerEssential responsibilities Compilation and execution of validation protocolsCompilation of validation summary...
-
Validation Engineer
1 day ago
Dublin, Dublin City, Ireland eTeam Inc Full timeLocation: Carlow, IrelandType of contract: Temporary Employment Contract for 12 months with hourly rateOur client: A global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines to improve human and animal health. With a strong commitment to research and development, the company focuses on addressing...
-
Validation Engineer
2 weeks ago
Dublin, Dublin City, Ireland The Aphex Group Full timeWe are seeking an experienced Validation Engineer with expertise in Vial and Syringe Filling operations for a leading biotech facility. The ideal candidate will have broad experience in the following areas:Sterile Operations (Isolators, VHP, Decontamination)Single Use Technologies (SUT) and Filter ValidationAncillary Equipment (Tube Welders, Glove Integrity...
-
Validation Engineer
2 weeks ago
Dublin, Dublin City, Ireland Thornshaw Recruitment Full timeOn behalf of our client, a global medical devices company, we are currently recruiting for a Validation Engineer. This is a permanent, full-site position based in North Wicklow/South Dublin.Reports toMaintenance, Engineering and Validation ManagerEssential responsibilitiesCompilation and execution of validation protocolCompilation of validation summary...
-
Validation Engineer
2 weeks ago
Dublin, Dublin City, Ireland Cpl Healthcare Full timeOn behalf of our client, a global medical devices company, we are currently recruiting for a Validation Engineer. This is a permanent, full-site position based in North Wicklow/South Dublin.Reports toMaintenance, Engineering and Validation ManagerEssential responsibilitiesCompilation and execution of validation protocolsCompilation of validation summary...
-
Validation Engineer
6 days ago
Dublin, Dublin City, Ireland PSC Biotech Corporation Full timeAbout PSC BiotechWho are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory...
-
Validation Engineering Lead
1 day ago
Dublin, Dublin City, Ireland NNIT Full time**Job Summary**">As a Validation Engineering Lead, you will oversee the validation activities for a range of equipment solutions within our regulated Pharma environment. Your key responsibilities will include managing and coordinating validation strategies, deliveringables, and documentation.**Key Responsibilities**Manage and coordinate the preparation,...
-
Process Validation Engineer
4 weeks ago
Dublin, Ireland Quanta Consultancy Services Ltd Full timeProcess Validation Engineer - Dublin, Ireland - 12-Month Contract Initially Are you looking for the chance to join a life-changing pharmaceutical organization in their mission to continuously drive innovation? We are recruiting for a Process Validation Engineer to support the company. Process Validation Engineer Responsibilities: 1. Support the...
-
Senior Validation Engineer
2 weeks ago
Dublin, Dublin City, Ireland ICDS RECRUITMENT CONSULTANTS LTD Full timeSenior Validation Engineer - South Dublin.As Senior Validation Engineer you will oversee and manage the validation and Advanced Product Quality Planning (APQP) lifecycle. In this pivotal role you will be responsible for leading the design transfer process and ensuring the technical aspects of the validation lifecycle are executed effectively. Additionally,...