Specialist Microbiology Virology

Vertex Ventures HC; Leinster; Hybrid; EUR 60,000 - 80,000; Full time

Job summary

Vertex Ventures HC is seeking a Specialist Microbiology Virology for its Dunboyne site. This role involves acting as an SME for microbiological methods, supporting the implementation and lifecycle management in pharmaceutical manufacturing. The ideal candidate will possess strong analytical and communication skills and a degree in microbiology or a related field, with significant industry experience.

Qualifications

• Minimum of bachelor’s degree, Master's is desirable.
• Over 4 years’ relevant experience in Pharmaceutical Microbiology/Virology.
• Knowledge of regulatory and quality guidelines (GMP).

Responsibilities

• Holds SME role for microbiological/virological methods.
• Supports evaluation, method development, method validation.
• Participates in Root Cause Analysis as SME.

Skills

Project management

Analytical skills

Technical skills

Communication

Education

Bachelor’s Level 8 Degree

Masters or equivalent through experience

Tools

GMP Compliance

Job description

Job Description

An amazing opportunity has arisen for a Specialist Microbiology Virology at Dunboyne. Within Our Manufacturing Division, the Micro Analytical Sciences (MAS) section within the Global Quality Large Molecule Analytical Sciences (GQLMAS) organization, located in Dunboyne which scientifically supports the microbiological laboratories in the commercial production sites for vaccines, biologics and small molecules. The MAS team plays a crucial role in supporting the transfer, troubleshooting and life cycle management of the microbiological test methods (including equipment) for all modalities. This includes compendial test methods, non-compendial test methods, and alternative microbiological methods. Furthermore, MAS is seen as the owner for global microbiological methods and equipment packages to structure the transfer of the microbiological test methods.

If leading-edge science and enhancing lives speak to your passions, this exciting opportunity could be your next career move.

As a Specialist Microbiology Virology, your energy, knowledge, innovation, and leadership will be invaluable in carrying out the following responsibilities:

• The individual holds a Subject Matter Expert (SME) role for one or more microbiological/virological methods.
• As an SME, the individual will have an important role in supporting from a practical perspective the implementation of microbiological/virological methods for a commercialized product and ensures the proper introduction and qualification of the microbiological/virological methods by the receiving unit (including Dunboyne site).
• The Specialist will also practically support as an SME the evaluation, method development, method validation and analytical lifecycle management of alternative microbiological technologies (Rapid Microbiology Methods).
• On an as-needed basis, the Specialist provides practical support for the alternative microbiological technologies (Rapid Microbiology Methods), microbiological studies and investigations supporting the Dunboyne site and/or network sites. This means that the SME offers hands-on assistance and expertise during these processes and travels as required for up to 20% of their time.

Bring energy, knowledge, innovation to carry out the following:

Scientific and Technical leadership

• Microbiological / Virological SME of at least two method / technique, with a scientific understanding of the microbial /virological techniques used in pharmaceutical industry.
• Responsible for best scientific practices within the lab space and supports from a microbiological perspective, troubleshooting, network and life cycle management activities in the Dunboyne site as well as for the network.
• Supports the implementation of microbiological methods (compendial/alternative microbiological methods) in a harmonized way to secure efficient implementation at the receiving unit (internally and/or externally).
• Provides scientific and practical support to analytical investigation during method suitability and routine use.
• Provides practical support for microbiological tests on an as-needed basis for methods and studies in their expertise for the transfer and commercialization of Biologicals/Vaccines.
• Participates as a SME in the evaluation, method development, method validation of alternative microbiological technology (Rapid Microbiology Methods).
• Responsible for authoring primary and secondary source documents used for regulatory filings.

Project Member and/or lead

• Support the implementation of microbiological methods at receiving units (internal and/or external Biological sites).
• Supports as SME the Dunboyne QC-Micro and AS&T team.
• Participates as SME in solving technical problems.
• Participates in Root Cause Analysis as SME for significant investigations.
• Participates as SME in multidisciplinary teams solving technical problems at global or multisite level.
• Participates in global change control processes as an SME or as change owner.

Compliance

• Takes GMP requirements into account when setting up experiments and protocols.
• Ensures compliance of protocols, lab data and reports.
• Ensures safety at personnel and at lab level.
• Participates as SME in multidisciplinary teams supporting Compliance topics ensuring global policies are in place for the network.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Minimum of bachelor’s Level 8 Degree, Masters is desirable or equivalent through experience.
• Over 4 years’ relevant experience in Pharmaceutical Microbiology/Virology.
• Project management skills.
• Knowledge of regulatory and quality guidelines (GMP).
• Able to work in multidisciplinary teams.
• Excellent analytical and technical skills with strong support focus.
• Demonstrated initiative, and innovative process-oriented thinking within a team environment.
• Excellent English communication skills (verbally and written)

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

API Manufacturing, API Manufacturing, Biopharmaceutical Industry, CNC Operations, Conventional Machining, Corporate Productions, Data Analytics, Detail-Oriented, Driving Continuous Improvement, Electronic Batch Records, Equipment Maintenance, Equipment Set Up, GMP Compliance, Good Manufacturing Practices (GMP), Maintenance Processes, Manufacturing Quality Control, Material Selection, Microbiological Analysis, Microbiological Test, Microbiology, Molecular Microbiology, Organizational Context, Pharmaceutical Management, Pharmaceutical Microbiology, Process Optimization {+ 5 more}

Preferred Skills:

Job Posting End Date:

06/18/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.