MSAT -Life cycle management - County Cork, Ireland - Cpl

    Cpl
    Cpl County Cork, Ireland

    1 week ago

    CPL background
    Description

    Kenny-Whelan (a specialist division of the CPL group) are hiring a MSAT specialist for the Lifecycle management Team to work on contract at Janssen Sciences in Ringaskiddy Cork

    MSAT Specialist – Lifecycle Management (12 months)

    Location: Ringaskiddy, Cork, Ireland

    Reports to: Senior Manager, Manufacturing Science & Technology

    Position Summary:

    We have an exciting opportunity for a MSAT Specialist to join our Life Cycle Management (LCM) team in the Manufacturing Science & Technology department at the Ringaskiddy site.

    The role is integral to driving successful outcomes in various MSAT activities, primarily focusing on Life Cycle Continuous Process Verification, Chromatography Resin Lifetime Verification, Statistical Process Control, and digital analytics. Secondary activities include, but are not limited to, supporting product investigations, process improvement projects and deploying new technologies.

    Main Duties & Responsibilities:


    • Execute MSAT activities in compliance with US and EU regulations, JSI procedures and EHS&S

    requirements.


    • Develop and maintain MSAT documentation such as strategies, plans, protocols, and reports.


    • Analyse process data, troubleshoot issues, and collaborate with cross-functional teams.


    • Review and approve documents prepared by MSAT colleagues.


    • Prepare reports for executed protocols for review and approval.


    • Liaise with Manufacturing to provide support where required with routine operations /

    project-based work.


    • Initiate and implement change control activities in accordance with site procedures.


    • Investigate and resolve exceptions/events/deviations during MSAT activities.


    • Participate in identified training sessions essential for fulfilling the role of an MSAT Specialist.

    Key Skills and Proficiencies Required:


    • Excellent interpersonal skills


    • Ability to operate as part of a team is essential.


    • Excellent communication skills both written and verbal.


    • Attention to detail.


    • Innovative with great problem-solving skills.


    • Results and performance driven.


    • Adaptable and flexible.


    • Integrity, trustworthiness and objectivity.


    • Knowledgeable of FDA/EMEA regulatory requirements.

    Required:


    • Minimum of a degree in a scientific/technical/engineering discipline.


    • Focus on patients and customers at all times.

    Desirable:


    • Experience in manufacturing, quality control or statistics/data science.


    • Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or

    pharmaceuticals.

    MUST ALREADY BE ELIGIBLE TO WORK ON CONTRACT IN THE REPUBLIC OF IRELAND- i.e have a valid work permit with 12 months permission + on it

    All applications will be treated with the strictest of confidence.

    Contact Jenn Dinan on or email the link below