Jobs
>
Validation Engineer
>
Sligo

    Validation Engineer - Sligo, Ireland - Orion Group

    Orion Group
    Orion Group Sligo, Ireland

    Found in: beBee S2 IE - 2 days ago

    Default job background
    Description

    Orion Group Life Sciences are currently recruiting a Validation Engineer on behalf of our Multinational Pharmaceutical Client based in Sligo on an initial 12-Month contract.

    Purpose:

    • To coordinate the development and maintenance of the company's validation program in
    • compliance with all applicable regulatory and company requirements.
    • Co-ordination, implementation and active participation in the site Validation Program.

    Responsibilities:

    • Ensure all Computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements.
    • Co-ordination / direction and active participation in the validation of site equipment,facilities, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.
    • Generation/maintenance of the Validation Master Plans.
    • Generation/maintenance of Project Validation Plans.
    • Generation of validation plans, protocols and final reports to cGMP standard.
    • Review / approval of all protocols and final reports.
    • Management of validation change control process.
    • Adheres to and supports all EHS & E standards, procedures and policies

    Supervision Received

    • Individual is given authority to carry out their duties without close supervision.
    • Reports to Validation Team Leader.
    • Goals are reviewed on a regular basis and formal performance reviews are carried out once per year.

    Supervision Provided

    • No direct reports.
    • Provide guidance to functional areas the area of Validation.
    • May provide cross training and guidance to new department members.

    Qualifications:

    • 3rd level qualification in a relevant engineering or scientific discipline.

    Job/Technical Skills

    • A minimum of 5-10 years' experience in a cGMP regulated environment.
    • A good understanding of regulatory requirements.

    Cognitive/Business Skills

    • Requires a high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times.
    • Requires proven problem-solving skills and the ability to adapt to new regulatory requirements.
    • Requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis.
    • Must be results driven striving to meet all targets and metric standards as set by site/department and division leaders.
    • Requires total commitment to quality and maintaining a high standard of work at all times.
    • Demonstrates the highest levels of integrity and a strong work ethic at all times
    • Strong communication skills both verbal and written are required for the execution of this role.
    • Strong interpersonal skills are required.
    • Supports the principles of Perfect Performance.

    Ownership and Accountability

    • The position has a high level of autonomy and individuals are expected to work on their own initiative.
    • Adheres to and follows all procedures policies and guidelines ensuring compliance with cGMP and HPRA/FDA regulations and company policies, procedures and guidelines.
    • Individual is fully responsible for the co-ordination and closure of projects assigned.
    • This position is crucial in identifying systems requiring validation and ensuring that this activity is documented, actioned and resolved.
    • This position impacts on product quality and technical performance as well as manufacturing operations.
    • Requires an ethos of Right First Time at all times.

    Influence/Leadership

    • Close contact with employees within the plant at all levels.
    • Close contact with internal and external auditors, e.g. FDA, HPRA.
    • May lead and chair Cross Functional Team meetings.
    • Provide technical leadership to functional areas and collaborates with key stakeholders.

    Decision Making/Impact

    • Expected to provide functional expertise to support daily operations.
    • Seeks Managers input when making decisions which affect the area.
    • Is a site SME on validation issues and provides guidance on same.
    • Decision making within confines of agreed responsibility with Team Leader.

    .

    Our role in supporting diversity and inclusion
    As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

  • AbbVie

    Validation Engineer

    Found in: Talent IE C2 - 3 days ago

    AbbVie Sligo, Ireland Full time

    Job Description · We are recruiting a Validation Engineer to join our site on Manorhamilton Road, Sligo. As our next Validation Engineer, coordinate the development and maintenance of the site validation program and ensure AbbVie and external regulatory, quality, and compliance r ...

  • TEAM HORIZON

    Validation Engineer

    Found in: Talent IE C2 - 2 days ago

    TEAM HORIZON Sligo, Ireland Permanent

    Team Horizon is seeking a Validation Engineer on a permanent basis for our client's manufacturing facility in the North West. Why you should apply: · You will get the opportunity to coordinate, implement and actively participate in the site Validation Program and general Techn ...

  • TEAM HORIZON

    Validation Engineer Contractor

    Found in: Talent IE C2 - 3 days ago

    TEAM HORIZON Sligo, Ireland Freelance

    Team Horizon is seeking a Validation Engineer for a 12-month contract for our client's manufacturing facility in Sligo. Why you should apply: · Exciting opportunity to join a global pharmaceutical company and join a dierse and experienced team · What you will be doing: · Ensu ...

  • Cpl

    Validation Engineer

    Found in: beBee S2 IE - 4 days ago

    Cpl County Leitrim, Ireland Full time

    Validation Engineer · My Client, a large medical equipment manufacturer in the north-west of Ireland is looking to recruit a Validation Engineer. · Responsibilities: · Ensuring that product introductions & change controls are effectively managed in accordance with the requiremen ...

  • Cpl

    Validation Engineer

    Found in: beBee S2 IE - 2 days ago

    Cpl County Leitrim, Ireland Full time

    Validation Engineer · Duties/ Accountabilities (incl. Deputation): · Ensuring that product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485, MDD 93/42/EEC & MDR 2017/745. · Participation in the new product introductions pro ...

  • Phibro Animal Health Corporation

    QA Specialist

    Found in: Talent IE C2 - 33 minutes ago

    Phibro Animal Health Corporation Sligo, Ireland

    Position Details · POSITION SUMMARY · The QA Specialist will be responsible for delivery of Quality Assurance activities to ensure product is manufactured in accordance with GMP and Regulatory requirements. The role will also include the review and approval of validation documen ...

  • Phibro Animal Health Corporation

    Process Scientist

    Found in: Talent IE C2 - 31 minutes ago

    Phibro Animal Health Corporation Sligo, Ireland

    About Phibro Animal Health Corporation · Phibro Animal Health Corporation is a publicly traded organization with a rich history spanning nearly 100 years of service. The Company is a global manufacturer of medicated feed additives, feed ingredients, advanced nutrition solutions, ...

  • TEAM HORIZON

    Senior Project Engineers

    Found in: Talent IE C2 - 3 days ago

    TEAM HORIZON Sligo, Ireland Freelance

    Senior Project Engineers - Biologics Process Equipment Team Horizon is seeking a Senior Project Engineers - Biologics Process Equipment for a leading pharmaceutical company in Sligo. · Why you should apply: · Our client has developed a stand-out culture of innovation, inclusio ...

  • TEAM HORIZON

    Clean Utilities Engineer

    Found in: Talent IE C2 - 3 days ago

    TEAM HORIZON Sligo, Ireland Freelance

    Clean Utilities Engineer · Team Horizon is seeking a Clean Utilities Engineer for a leading manufacturing company in Sligo. · Why you should apply: You enjoy working on exciting projects and want to work with a global manufacturing site in Sligo. · Our client has developed a st ...

  • TEAM HORIZON

    Senior Automation Engineer

    Found in: Talent IE C2 - 3 days ago

    TEAM HORIZON Sligo, Ireland Freelance

    Senior Automation Engineer Team Horizon is seeking a Senior Automation Engineer for a leading pharmaceutical company in Sligo. · Why you should apply: · This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably ...

  • Abbott

    Manufacturing Process Engineer

    Found in: Talent IE C2 - 1 day ago

    Abbott Sligo, Ireland

    About Abbott Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded ...

  • TEAM HORIZON

    Project Coordinator

    Found in: Talent IE C2 - 33 minutes ago

    TEAM HORIZON Sligo, Ireland Permanent

    Team Horizon currently has an exciting opening for Project Coordinator to join their client's rapidly growing team in Sligo. This is an exciting opportunity to join a growing clinical trial company in a fast paced start up environment, where you will be responsible for supporting ...

  • TEAM HORIZON

    Lab & Mfg Systems Engineer

    Found in: Talent IE C2 - 2 days ago

    TEAM HORIZON Sligo, Ireland Permanent

    Team Horizon is seeking a Lab & Mfg Systems Engineer for our client based in Sligo. The Lab & IT System Engineer primary duties will include but not be limited to providing hands on end user support, administration, installation, and issue resolution for GxP controlled laboratory ...

  • AbbVie

    Automation Manager

    Found in: Talent IE C2 - 2 days ago

    AbbVie Sligo, Ireland Full time

    Job Description · We are now recruiting an Automation Manager to join the team at our site in Sligo (Manorhamilton Road). The successful candidate will be responsible for Automation systems and procedures for the site. They will work within the Engineering Team to provide ownersh ...

  • TEAM HORIZON

    Program Manager

    Found in: Talent IE C2 - 3 days ago

    TEAM HORIZON Sligo, Ireland Freelance

    Team Horizon is seeking a Program Manager (initial 12-month contract) for a global biopharmaceutical client, for their manufacturing site in Sligo. Why you should apply: · This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track ...

  • Phillips-Medisize

    Quality Engineer

    Found in: Talent IE C2 - 3 days ago

    Phillips-Medisize Sligo, Ireland

    Your Job · The main focus of the role is primarily to ensure the quality standards are met. In this role you will form part of a cross functional team involved in the day-to-day activities and other QMS activities as needed. You will be working in both manufacturing & non-manufa ...

  • AbbVie

    Leader, Technical Shift

    Found in: Talent IE C2 - 16 hours ago

    AbbVie Sligo, Ireland Full time

    Job Description · We are looking for a Technical Shift Leader to join our start-up API Pilot Plant in Sligo. This is an 18 month Fixed Term Contract. The position reports to the API Manufacturing Manager and will have circa. 7 direct reports. · This is an exciting opportunity to ...

  • TEAM HORIZON

    API Technical Shift Lead

    Found in: Talent IE C2 - 2 days ago

    TEAM HORIZON Sligo, Ireland Permanent

    Team Horizon is seeking a Technical Shift Lead with API experience for a leading Pharmaceutical company in Sligo. Why you should apply: · This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering hig ...

  • AbbVie

    Biologics Technician

    Found in: Talent IE C2 - 2 days ago

    AbbVie Sligo, Ireland Full time

    Job Description · Innovate with intention. · Science is at the heart of what we do. People are at the heart of why we do it. · Welcome to AbbVie · We are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expert ...

  • AbbVie

    Pharmaceutical Technician

    Found in: Talent IE C2 - 3 days ago

    AbbVie Sligo, Ireland Full time

    Job Description · What you do, is what we need. Making a difference begins here. And takes all of us. · Welcome to AbbVie · We are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of a ...