Sr. Tech, Quality Control

Merck Gruppe - MSD Sharp & Dohme; Dunboyne; On-site; EUR 45,000 - 65,000; Full time

Job summary

A leading pharmaceutical company based in Dunboyne, County Meath, is seeking a Senior QC Microbiology Analyst to ensure compliance with quality standards and support laboratory activities. The ideal candidate will have at least 5 years of experience in microbiology within the pharmaceutical sector. This critical role involves conducting microbiological analyses, training team members, and contributing to quality improvement efforts. An exciting opportunity for those looking to impact the future of healthcare.

Qualifications

• Minimum of a bachelor’s Level 8 degree in a technical discipline (e.g. microbiology, biochemistry, chemistry) or equivalent.
• Ideally 5 years’ experience working in Microbiology in the pharmaceutical industry.
• Proven record of accomplishments in a regulated industry.
• Experience of plant microbiology and contamination control.

Responsibilities

• Conducting microbiology analysis including bioburden testing and microbial identification.
• Ensure compliance with cGMP and corporate regulations.
• Support Microbiology Laboratory activities and team training.
• Investigate out-of-specification results and own corrective actions.

Skills

Problem-solving skills

Coordination and organizational skills

Excellent communication skills

Knowledge of cGMP requirements

Leadership skills

Education

Bachelor’s Level 8 degree in a technical discipline

Tools

Laboratory Information Management System (LIMS)

Calibration Management Software

Job description

Job Description

An amazing opportunity has arisen for a QC Senior Microbiology Analyst. This role is part of the BioCEL QC Microbiology Self-Directed work team/ Hub in our new state of the art single use multi-product biotech facility in Dunboyne, County Meath, Ireland. The organisational structure at the site is based on self-directed work teams where decisions will be made at the level where the data exists.

The Senior QC Microbiology Analyst will work across the site self-directed work teams and hub teams to identify and resolve issues in order to allow the site to deliver on our commit culture that support Quality, EHS, Learning and Continuous improvement. The Senior Analyst will be responsible for supporting Microbiology Laboratory/Plant Start-up and sustaining/run the business activities at the new single use multi-product biotech facility in Dunboyne, County Meath, Ireland.

The overall responsibility for this role will be to support the Microbiology Quality Control testing function, ensuring compliance with cGMP and corporate regulations. This is a critical role within the Quality organisation to help establish the Laboratories as a hub for specialised analytical testing and create value for our patients.

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

• Conducting microbiology analysis including bioburden testing, endotoxin testing, microbial identification, Biological Indicator testing, BacT/ALERT testing, sterility checks, and growth promotion of media as required.
• Carry out environmental monitoring including viable and non-viable particulate monitoring in cleanroom areas of the manufacturing facility.
• Authoring and reviewing of Trend Reports/SOPs
• Utility (water and gas) system monitoring.
• Participate in the technical transfer / validation / verification of microbiological and analytical testing procedures.
• Train and support members of the team in microbiological test methods.
• Support the site aseptic training program and contamination control strategy of the facility to ensure the highest level of quality and practices in support of our patients.
• Ensure that all cGMP, company specifications, procedures and guidelines are followed.
• Investigate Out of Specification (OOS) and Out of Trend (OOT) results as required.
• Investigate Non-Conformances and actively lead subsequent corrective actions as required.
• Own and support CAPAs.
• Own and support Change Controls and Change Actions.
• Support Audit Readiness and participate in Audits.
• Support Commissioning Qualification Validation activities as required.
• Support and participate in Quality Risk Assessments.
• Support instrument calibration and maintenance as required.
• Perform GEMBA Walks of the laboratory and cleanroom areas.
• Adhere to site documentation practices and prepare and review document change requests as required.
• Use Global LIMS/MODA or other computerized systems for entering and approving test results as applicable. Support system builds.
• Scheduling and coordinating the QC Microbiology lab activities.
• Review and approval of QC data.
• Supporting analytical instrument qualification.
• Coaching and mentoring the team.
• Leading/supporting projects and on-time project delivery.
• Trouble shooting and problem-solving.
• Drive Key Performance Indicators.
• Proven ability through working across teams focusing on meeting and tracking to schedules and embracing and interdependent work culture as an agile team member.
• Promoting a culture where diversity and inclusion is part of the DNA.
• Collaborates with cross-functional teams to deliver the site objectives.
• Work under minimal supervision and on own initiative.

What skills you will need:

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

• Minimum of a bachelor’s Level 8 degree in a technical discipline (e.g. microbiology, biochemistry, chemistry) or equivalent.
• Ideally 5 years’ experience working in Microbiology in the pharmaceutical industry, preferably in a Biologics company.
• Coordination and organizational skills – Ability to manage multiple priorities and projects and escalate issues for resolution where required.
• Excellent problem-solving skills.
• Proven record of accomplishments in a regulated industry.
• Experience of plant microbiology and contamination control, microbiology testing and method validation.
• Excellent communication skills (written and oral).
• Strong knowledge of cGMP requirements for manufacturing and/or systems and compliance.
• Required to work on his/her own initiative, as part of a team and proven leadership skills.
• Demonstrated ability to coach team members to promote a high performing team.
• Demonstrated ability to give and receive feedback.
• Demonstrated understanding of continuous quality / process improvement tools (As defined by the site, e.g. DMIAC, 8 Step problem solving, 5S, MPS etc).

As a company, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology,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:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Analytical Method Development, Analytical Method Development, Analytical Method Transfer, Analytical Testing, Animal Husbandry, Bioburden Testing, Biochemistry, Calibration Management Software, Chemical Analysis, Coach Team Members, Contamination Control, Diversity and Inclusion (D&I), ELISA Techniques, Environmental Monitoring, Laboratory Information Management System (LIMS), Management Process, Microbial Assays, Microbial Identification, Microbiological Analysis, Microbiology, Organizational Structures, Particulate Monitors, Process Improvements, Project Delivery, QC Microbiology {+ 5 more}

Preferred Skills:

Job Posting End Date:

08/28/2025

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

Requisition ID:R359325