QC Equipment Validation Specialist New

2 days ago

Dublin, Dublin City, Ireland CPL Full time
Cpl in partnership with our client Pfizer are seeking a QC Equipment Validation Specialist to join the team at their state of the art site in Dublin, Grange castle for a 12 month fixed term contract. This is an onsite role.

Job Purpose:

Working as part of the QC Laboratory Equipment Validation Team you will be responsible for the qualification of new instrumentation, modernisation of instrumentation, and facility modification or expansion projects within the QC Laboratories.

Job Tasks:

- Execute all aspects of QC instrument and equipment validation support throughout the validation lifecycle:
- New instrument and equipment validation (URS, IQ, OQ, PQ, Traceability Matrices, Summary Reports
- Periodic review of instrument qualification packages as required
- Routine QC support with respect to instrument issues
- Instrument and equipment validation scheduling
- Administration of Laboratory Computerized Systems.
- Liaise with Vendors, Calibration, EHS, QA and QC to deliver instrument qualification and re-qualification schedules.
- Preparation and review of required validation documentation including protocols and reports.
- Ensure data integrity requirements are included and met as part of the new instrument qualification.
- Establishment of procedures for management and maintenance of the validated system (data archive, project creation, security etc.).
- Generation of area and System Administration SOPs.
- Authoring, review and approval of qualification/validation protocols and reports, status reports, regulatory documents and process descriptions.
- Completion of Security reviews, periodic reviews, compendial reviews and APQR sections as they relate to maintaining the qualified status of the system
- Cover the QC investigation process by providing accurate and concise information in a timely manner and raising investigations, where required, in QTS and eQMS.
- Participate in cross functional teams as required to provide support on, and resolution of, QC instrument and equipment validation requirements.
- Partner closely with customers and stakeholders to comprehend QC instrument and equipment validation requirements and escalate when necessary.
- Proactive engagement with customers and key stakeholders.
- Maintain the QC laboratories in a state of audit readiness at all times.
- Participate in new initiatives such as the 5S, Standard Work, Data Integrity and IMEX programs as they arise.
- Participate in and drive the continuous improvement of all aspects of the group.
- Ensure compliance with cGMP, corporate standards / Pfizer Quality System (PQS), site policies / procedures, and regulatory requirements.
- Technical writing assignments including SOPs, trend reports, risk assessments, laboratory investigations, and change controls.

Education / Experience:

- You will be service orientated; delivery focused and can build rapport with key stakeholders both internal and external.
- Relevant Third level Qualification or equivalent (B.Sc. degree in science, engineering, quality, technical or other related life sciences or engineering discipline.
- 1+ years relevant experience in industry, preferably in a pharmaceutical or relevant GMP manufacturing environment.
- Knowledge and experience of validation or qualification experience with laboratory instrumentation, validation, and project lifecycle, ideally within a pharma / biopharma FDA regulated environment.
- Excellent communication and social skills.
- Experience in updating documentation and reports.
- Working knowledge of IT systems and their interactions with laboratory instrumentation would be considered an advantage but not essential.
- An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.

Work Location Assignment: On Premises

  • QA Systems and Validation Specialist New

    2 weeks ago

    Dublin, Dublin City, Ireland CPL Full time

    QA Systems and Validation Specialist(12 month Contract)Location: Swords Campus,ABOUT US?SK biotek Ireland, an SK pharmteco company, is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and Ireland. We are part of the wider SK Inc. with revenues of $95 billion in 2020. Our mission is to...

  • QC Equipment Associate

    1 week ago

    Dublin, Dublin City, Ireland Life Science Consultants (LSC) Full time

    LSC have a great contract opportunity for a QC Equipment Associate to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging. If you have 3+ years of experience working in the pharmaceutical or biotechnology industry ideally within QC and are ready for your...

  • QC Specialist

    2 days ago

    Dublin, Dublin City, Ireland Joynes & Hunt Full time

    QC SpecialistLocation: Shannon, IrelandOur client is a gene therapy company that works with gene therapy discovery, development and GMP manufacturing. They have headquarters in London and the USA and have recently redesigned exciting new labs with cutting edge technology and the ability to work to a higher standard and increase their capacity of...

  • Qc Equipment Associate

    20 hours ago

    Dublin, Dublin City, Ireland Life Science Consultants (Lsc) Full time

    LSC have a great contract opportunity for a QC Equipment Associate to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.If you have 3+ years of experience working in the pharmaceutical or biotechnology industry ideally within QC and are ready for your next...

  • QA Systems and Validation Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    QA Systems and Validation Specialist(12 month Contract)Location: Swords CampusABOUT USSK biotek Ireland, an SK pharmteco company, is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and Ireland. We are part of the wider SK Inc. with revenues of $95 billion in 2020. Our mission is to...

  • QA Systems and Validation Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland DPS Group Global Full time

    Position Description:The QA Systems and Validation Specialist will be responsible for:Assessment of changes for GMP compliance in accordance with site change control procedure for facilities, utilities, lab and manufacturing equipment and control system changes.Review and approve the GMP design aspects of major capital projects including new facility...

  • QA Validation Specialist New 2/8/2025 A

    1 week ago

    Dublin, Dublin City, Ireland CPL Full time

    Cpl in partnership with our client Pfizer are Seeking a QA Validation Specialist to join the team at their state of the art Dublin, Grange Castle Plant for an 11 month fixed term contract with Hybrid working model. Role:To provide a compliance overview of sitewide validation activities. To provide technical QA support to the Engineering function (including...

  • QC External Support Specialist New

    1 week ago

    Dublin, Dublin City, Ireland CPL Full time

    Cpl in partnership with our client are seeking a QC External Supply Specialist to join the team at their state of the art site in Dublin, Grange castle for an 11 month fixed term contract with hybrid working. About the Role / Job Responsibilities- Management of external analytical method transfer and new product introduction projects including mRNA products...

  • QC External Support Specialist New

    1 week ago

    Dublin, Dublin City, Ireland CPL Full time

    Cpl in partnership with our client are seeking a QC External Supply Specialist to join the team at their state of the art site in Dublin, Grange castle for an 11 month fixed term contract with hybrid working. About the Role / Job Responsibilities- Management of external analytical method transfer and new product introduction projects including mRNA products...

  • QA Validation Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Cpl in partnership with our client Pfizer are Seeking a QA Validation Specialist to join the team at their state of the art Dublin, Grange Castle Plant for an 11 month fixed term contract with Hybrid working model.Role:To provide a compliance overview of sitewide validation activities. To provide technical QA support to the Engineering function (including...

  • Validation Engineer

    2 weeks ago

    Dublin, Dublin City, Ireland VALIDATION ASSOCIATES LLC Full time

    The 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...

  • QC External Support Specialist

    1 week ago

    Dublin, Dublin City, Ireland Cpl Resources - TEG Full time

    Cpl in partnership with our client are seeking a QC External Supply Specialist to join the team at their state of the art site in Dublin, Grange castle for an 11 month fixed term contract with hybrid working. About the Role / Job Responsibilities Management of external analytical method transfer and new product introduction projects including mRNA products...

  • QC Analyst New

    3 days ago

    Dublin, Dublin City, Ireland CPL Full time

    QC Microbiology SpecialistDublin 15- 8 month contract- must have minimum stamp 1G visa valid until end of 2025Reporting to the QC Microbiology Manager, the QC Microbiology Specialist will be responsible for supporting Drug Substance and Drug Product site activities related to Bioburden and Endotoxin in-process testing and sample processing.Key Duties and...

  • QC Instrument Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland Quanta part of QCS Staffing Full time

    QC Instrument Specialist – Pharmaceuticals – 12 Month Contract – Dublin Do you want to be part of one of the top 10 best companies to work for in Ireland? If so, this could be your chance One of our global pharmaceutical clients is looking for a QC Instrument Specialist to join their team in Dublin for their new large-scale facility. This is a...

  • QA Validation Lead New

    3 weeks ago

    Dublin, Dublin City, Ireland CPL Full time

    Cpl in partnership with The SK pharmteco Small Molecule facility located in Swords, Co Dublin, are looking for a QA Validation Lead to join the team on a 12 month contract.ABOUT US?SK pharmteco is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and Ireland. We are part of SK Inc., a...

  • QC Instrumentation Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland PSC Biotech Corporation Full time

    Job DescriptionAbout PSC BiotechWho we are?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...

  • QC Instrumentation Specialist

    1 day ago

    Dublin, Dublin City, Ireland PSC Biotech Full time

    Job DescriptionAbout PSC BiotechWho we are?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...

  • 3/10/2025 A) Cleaning Validation Specialist New

    3 days ago

    Dublin, Dublin City, Ireland CPL Full time

    Cpl in partnership with our client Pfizer are seeking a Cleaning Validation Specialist to join the team for an 11 month Fixed term Contingent contract at their state of the art plant in Dublin Grange Castle. CLEANING VALIDATION SPECIALISTJob Purpose:Pfizer Grange Castle seeks a Cleaning Validation Specialist to work within the Cleaning Validation Team...

  • QC Technical Services

    1 week ago

    Dublin, Dublin City, Ireland Life Science Recruitment Ltd Full time

    AMC4049 12 month contract South Dublin - Hybrid QC Technical Services - Equipment Support Overview: We are looking for an experienced professional to manage the qualification, calibration, and routine maintenance of laboratory systems in a cGMP Quality Control environment. This role involves ensuring compliance with regulatory standards, maintaining...

  • Cleaning Validation Specialist

    2 days ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Cpl in partnership with our client Pfizer are seeking a Cleaning Validation Specialist to join the team for an 11 month Fixed term Contingent contract at their state of the art plant in Dublin Grange Castle.CLEANING VALIDATION SPECIALISTJob Purpose:Pfizer Grange Castle seeks a Cleaning Validation Specialist to work within the Cleaning Validation Team...