Senior Lead Microbiology Analyst – QC

3 weeks ago

Limerick, Ireland Lilly Full time

We’re looking for people who are determined to make life better for people around the world.

Lilly is currently constructing a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This facility will be Lilly’s most technically advanced manufacturing site and will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and increased productivity and process performance. This is a unique opportunity to be a part of the technical team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the technical capabilities to enable a successful startup of cGMP manufacturing operations.

Outline of Role:

The Senior Lead Microbiology Analyst – QC role provides support to the start up and routine operations of the QC microbiology laboratory and works closely with the area technical lead and management. During start-up of the QC laboratories the role will be focused on developing E-systems, procedures and implementing test methods to support routine operations. This role will have oversight for the implementation and execution of the training programme for the QC microbiology analyst group. Furthermore, the role will focus on the implementation of data integrity requirements for microbiology laboratory equipment. 

Key Responsibilities:

QC Testing

Safety : Safety first approach to activities. Method verification: Author and execute method verification protocols for microbiological test methods such as bioburden and endotoxin. Study support: Provide support for microbiological studies through protocol and report authoring; study execution; data review and data analysis. Equipment SME: Serve as equipment SME for microbiology lab test equipment.

Compliance and Documentation :

cGMP Compliance : Ensure all microbiological aspects of testing adhere to current Good Manufacturing Practices (cGMP). Ensure correct practices are in place in compliance with regulations, global standards and aligned with the site Data Management strategy. Data Review and Investigation : Lead microbiology laboratory investigations including alert and action limit excursions and deviations. Identify and implement corrective actions as needed. Documentation : Maintain accurate and detailed records. Author procedures, protocols, reports, investigations and change controls as required. Data integrity ; Participate in data integrity assessments for area equipment and activities. Participate in and coordinate audit trail review process in collaboration with Quality Assurance/stakeholders. Inspection readiness : Support and participate in self-inspections or regulatory audits.

Training and Process Improvement :

Training and Leadership : Develop training material and lead training for new analysts within the microbiology team in techniques such as bioburden, endotoxin, growth promotion, environmental monitoring, microbial identifications, TOC, conductivity etc. Process Enhancements : Proactively identify opportunities for process improvements in the laboratory and support implementation. Benchmark best practices for analytical technology and implement appropriate improvements. Collaboration : Provide technical support to lab analysts and operations as required.

Basic Qualifications/Requirements:

Bachelor’s degree in Microbiology, Biology, or related field. Minimum of 6 years of experience in microbiology testing within a pharmaceutical or biotechnology environment.

Job specific pre-requisites:

Deep technical expertise in QC microbiology techniques. Significant level of cross training and demonstrated training ability on multiple microbiological techniques (e.g., aseptic technique, bioburden, endotoxin, growth promotion, environmental monitoring, and microbial identification).  Good understanding of data integrity in the QC laboratory Good understanding of regulatory requirements for micro testingDemonstrated excellent analytical technical, attention to detail and problem-solving skills.Demonstrated expertise in a variety of microbiological techniques.Demonstrated strong interpersonal skills.Demonstrated strong verbal and written communication skills.Demonstrated ability to participate in and facilitate decision-making.Good IT skills and knowledge of standard software packages (e.g. Microsoft Word, Excel) as well as laboratory-based software (e.g. LIMS systems, electronic lab notebooks etc..).Demonstrated good planning and organisational skills, ability to prioritise tasks, commitment to task completion and timelines.Demonstrated initiative – able to work proactively without direct supervision, continuous improvement mind-set.Coaching and mentoring capabilitiesProficient in English.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

#WeAreLilly

  • QC Lab Analyst Job Limerick

    3 days ago

    Limerick, Ireland FRS Recruitment Full time

    QC Lab Analyst Job Limerick FRS Recruitment are proud to be recruiting on behalf of an International Biotechnology company in the Mid- West who are looking to significantly expand their Quality Control Operations. Seeking a candidate with min 9-12 months GMP industry experience (essential) along with a degree qualification in a Scientific discipline. A...

  • Microbiology Team Lead

    4 weeks ago

    Limerick, County Limerick, Ireland Complete Laboratory Solutions Full time

    Overview: CLS is currently going through an unprecedented and exciting period of growth and development and is now looking for an experienced Microbiology Team Manager to lead our managed service team on-site at our client’s facility in Limerick. This is an exciting opportunity to join CLS as a full-time employee while acting as a key support for our...

  • Microbiology Analyst

    4 weeks ago

    Limerick, County Limerick, Ireland Complete Laboratory Solutions Full time

    CLS is Ireland’s leading provider of sampling, analysis and on-contract analysts to the food, environmental, pharmaceutical and medical device industries. Founded in 1994, CLS is renowned for delivering high-quality laboratory data, always on time and in the most customer-focused way. CLS is currently going through an unprecedented and exciting period of...

  • Senior Laboratory Analyst

    3 weeks ago

    Limerick, Ireland Westbourne IT Global Services Full time

    Job Description: Laboratory Analyst - LIMS We are seeking a highly motivated Laboratory Analyst with experience in Laboratory Information Management Systems (LIMS) to join our team. The successful candidate will be responsible for building the content of Quality Control Laboratory Information Management Systems in collaboration with site and external...

  • Senior Laboratory Analyst

    3 weeks ago

    Limerick, Ireland Westbourne IT Global Services Full time

    Job Description: Laboratory Analyst - LIMS We are seeking a highly motivated Laboratory Analyst with experience in Laboratory Information Management Systems (LIMS) to join our team. The successful candidate will be responsible for building the content of Quality Control Laboratory Information Management Systems in collaboration with site and external...

  • Senior/Principal/Senior Principal Microbiologist

    3 weeks ago

    Limerick, Ireland Cpl Healthcare Full time

    Senior/Principal/Senior Principal Microbiologist - Technical Services/Manufacturing Sciences The TS/MS Microbiologist will be responsible for establishing and implementing the operational microbiological, viral and environmental monitoring programs at the Limerick manufacturing site. As the microbiology lead for the facility the successful candidate will...

  • Senior/Principal/Senior Principal Microbiologist

    4 weeks ago

    Limerick, Ireland Cpl Full time

    Senior/Principal/Senior Principal Microbiologist - Technical Services/Manufacturing SciencesThe TS/MS Microbiologist will be responsible for establishing and implementing the operational microbiological, viral and environmental monitoring programs at the Limerick manufacturing site. As the microbiology lead for the facility the successful candidate will...

  • Senior/Principal/Senior Principal Microbiologist

    3 weeks ago

    Limerick, Ireland Cpl Full time

    Senior/Principal/Senior Principal Microbiologist - Technical Services/Manufacturing SciencesThe TS/MS Microbiologist will be responsible for establishing and implementing the operational microbiological, viral and environmental monitoring programs at the Limerick manufacturing site. As the microbiology lead for the facility the successful candidate will...

  • Senior/Principal/Senior Principal Microbiologist

    2 weeks ago

    Limerick, Limerick, Ireland Cpl Full time

    Senior/Principal/Senior Principal Microbiologist - Technical Services/Manufacturing SciencesThe TS/MS Microbiologist will be responsible for establishing and implementing the operational microbiological, viral and environmental monitoring programs at the Limerick manufacturing site. As the microbiology lead for the facility the successful candidate will...

  • Senior/Principal/Senior Principal Microbiologist

    3 weeks ago

    Limerick, Ireland Cpl Full time

    Senior/Principal/Senior Principal Microbiologist - Technical Services/Manufacturing SciencesThe TS/MS Microbiologist will be responsible for establishing and implementing the operational microbiological, viral and environmental monitoring programs at the Limerick manufacturing site. As the microbiology lead for the facility the successful candidate will...

  • Senior/Principal/Senior Principal Microbiologist

    3 weeks ago

    Limerick, Ireland Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. Senior/Principal/Senior Principal Microbiologist - Technical Services/Manufacturing Sciences Owing to the continuous growth of our Monoclonal pipeline of products, Eli Lilly & Company has invested in a new facility in Ireland, Lilly Limerick. To support this...

  • Laboratory Analyst – LIMS

    3 weeks ago

    Limerick, Ireland Westbourne IT Global Services Full time

    Job Responsibilities:  The key responsibilities of the Laboratory Analyst – LIMS hall include but shall not be limited to:  - Building the content of QCL LIMs systems in collaboration with site and external Digital teams.  - Translating the content of specifications and analytical methods into compliant, effective and efficient LIMs / LES...

  • Laboratory Analyst

    3 weeks ago

    Limerick, Ireland Westbourne IT Global Services Full time

    JobResponsibilities: The key responsibilities of the Laboratory Analyst – LIMS hall include but shall not be limited to: - Building the content of QCL LIMs systems in collaboration with site and external Digital teams. - Translating the content of specifications and analytical methods into compliant, effective and efficient LIMs / LES workflows. -...

  • Data Analyst Mid, Senior or Lead

    3 weeks ago

    Limerick, Ireland Cpl Healthcare Full time

    About the job This client is uniquely positioned to define the future of Health Technology – with a profound purpose, to help people live longer and better by predicting and preventing health issues earlier. It’s all about simplifying healthcare. Founded in 2017 as a fully owned subsidiary of a major US Healthcare company, we are committed to...

  • Data Analyst Mid, Senior or Lead

    3 weeks ago

    Limerick, Ireland Cpl Full time

    About the job This client is uniquely positioned to define the future of Health Technology – with a profound purpose, to help people live longer and better by predicting and preventing health issues earlier. It’s all about simplifying healthcare.  Founded in 2017 as a fully owned subsidiary of a major US Healthcare company, we are...

  • Plant Microbiologist

    2 weeks ago

    Limerick, Ireland Harry Walsh Associates Ltd. Full time

    Plant Microbiologist required for a leading Biopharma site. The Microbiologist will be responsible for establishing and implementing the operational microbiological, viral and environmental monitoring programs at the new manufacturing site. The successful candidate will provide technical support for the facility startup defining microbial and viral control...

  • Business Systems Analyst

    2 days ago

    Limerick, Ireland AMCS Group Full time

    Do you want to work for an Irish company with global reach?A leader in environmental services, AMCS is a trailblazing software company that guides and supports other businesses on their journey towards sustainability. AMCS leads the way The AMCS team is at the cutting edge of technology.Companies come to AMCS to achieve their sustainability strategies as...

  • Business Systems Analyst

    3 weeks ago

    Limerick, Ireland AMCS Group Full time

    DIGITAL WAYS TO A CLEANER WORLD Do you want to work for an Irish company with global reach? A leader in environmental services, AMCS is a trailblazing software company that guides and supports other businesses on their journey towards sustainability. AMCS leads the way The AMCS team is at the cutting edge of technology. Companies come to AMCS to...

  • Senior Data Engineer

    5 days ago

    Limerick, Ireland Cpl Healthcare Full time

    DESCRIPTION The Role Our client is looking for a Data Engineer to join a fast-paced, innovative, and highly visible team building data-driven digital solutions. The position is based at their Limerick office in Ireland, 3 days a week. Key Responsibilities · Develop a strong understanding of the business, strategic direction, overall organizational goals...

  • Senior Human Resource Analyst

    4 weeks ago

    Limerick, County Limerick, Ireland Regeneron Ireland DAC Full time

    Within this role, you will be responsible for handling queries, anomalies, and challenges related to the benefits portal. You will also manage benefit programs and ensure accurate data transfer to payroll. Moreover, you will act as the main point of contact for employees' inquiries regarding benefits and compensation and provide support in HR cases and...