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    MSAT Specialist- Commercial Products - 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 -Commercial Products to work on contract at Janssen Sciences in Ringaskiddy Cork

    We have a great opportunity for a MSAT Specialist to join our MSAT team at the Ringaskiddy

    site. This would be approximately a 12-month contract position.

    The MSAT Specialist is an integral member of the MSAT team, delivering successful

    outcomes to all MSAT activities. Primary activities are in the area of Life Cycle Process

    Validation, 2nd line technical support to operations, process improvement, New Product

    Introduction (NPI) and focus on new technology deployment.

    Main duties and responsibilities:

    · Providing detailed SME technical knowledge, in a 2nd line support role to

    Manufacturing Operations, with particular focus on commercial products.

    · Acting as site Technical Owner of commercial products on the Cork site, leading and

    coordinating any changes to products, and supporting technical discussions related

    to the manufacture of products.

    · Leading and /or providing technical guidance into process improvement projects,

    commercial product scale up projects and NPI.

    · Championing the roll out of new technology to improve our processes.

    · Coordinating and driving LCM activities (Process Qualification and Continued Process

    Verification).

    · Representing the Cork MSAT site team on LCM platform technical teams.

    · Preparing, reviewing, and approving technical documents, CAPAs, change control,

    deviations, and metrics.

    · Supporting GMP documentation generation (e.g., protocols / SOPs / WIs / Technical

    Documents, Exception/Event Investigations).

    · Leading complex multi-functional investigations

    · Providing technical support / direct participation as technical SME in partnership

    with Quality and Operations for regulatory audits and inspections.

    · Participate in multi-functional teams as required.

    · Conduct activities in compliance with US and EU regulations, JSI procedures and

    EHS&S requirements.

    Key Skills and Proficiencies required:

    · Excellent interpersonal skills.

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

    · Proven leadership skills and critical thinking ability.

    · 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.

    Education and Experience:

    Required:

    · A minimum of a Degree in Science or Engineering is required.

    · At least 3 yrs experience in the Large Molecule manufacturing industry or equivalent.

    · Focus on patients and customers at all times.

    Desirable:

    · Strong expertise in Downstream processes of Bio-pharmaceutical manufacturing

    (Large Molecule API) and equipment.

    · Process excellence (6sigma), lean concepts and statistical skills.

    · Ability to lead multi-functional team and to manage complexity and change.

    · Ability to interact at different levels of the organization and handle conflicting

    interests.

    · Ability to work independently under general direction, having a good sense of

    prioritization of goals and good time management.

    · Demonstrated knowledge and application of industry regulations including those of

    FDA, HPRA, EMEA and other authorities.

    All applications will be treated with the strictest of confidence.

    Contact Jenn Dinan on or email the link below

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