Job Description
A fantastic opportunity has arisen for aMetrology Specialist, at our state-of-the-art single-use multi-product biotech facility, in Dunboyne.
You will work as part of the integrated commercialization team in Global Quality Large Molecule Analytical Sciences (GQLMAS) and be pivotal in driving a culture of quality and operational excellence across the global network. This role is responsible for supporting the management and execution of the calibration and maintenance program for analytical instruments and laboratory equipment within the GMP environment at our Dunboyne site.
Bring energy, knowledge, innovation to carry out the following:
- Work independently as directed by the Metrology Validation (MV) lead, according to Company safety policies and cGMP/cGLP procedures.
- Drive compliance with our company policies, procedures, guidelines, and regulatory requirements and execute Good Manufacturing Practices (cGMP) in day-to-day activities.
- Review and approve instrument calibration, maintenance, validation data.
- Maintain analytical instrumentation and equipment under the responsibility of MV in a state of permanent inspection readiness.
- Track and maintain key metrics for the department and the site as communicated by the MV lead.
- Author and review local SOPs and deviation investigations as required.
- Oversight of external vendor engineers to ensure execution of calibration and maintenance activities in alignment with approved company and departmental procedures and requirements.
- Together with on-site Laboratory Asset Management Program (LAMP) coordinators, ensure calibration maintenance services are scheduled in accordance with documented due dates or ad hoc as required to support business needs.
- Collaborate with stakeholder area representatives to execute and deliver team objectives.
- Serve as subject matter expert for the MV calibration and maintenance program during internal audits and regulatory inspections.
In order to excel in this role, you will more than likely have:
- Degree in analytical chemistry or related field with experience in metrology, qualification, and computer system validation within a GMP environment.
- Experience in auditing and compliance within the pharmaceutical industry.
- Experience in change management and deviation management.
- Proven ability working cross functionally, with focus on meeting and tracking schedules and embracing an interdependent work culture.
- A proven ability to manage multiple priorities and know when to escalate issues for visibility and resolution.
- Ability to think logically and be proactive under pressure.
This is a site-based role with opportunity for hybrid working when required. An 8-week look-ahead is available to plan vendor-related onsite activity. A minimum of 3 days onsite a week is to be expected.
Our facility in Dunboyne joined our network in September 2020. Our Dunboyne site is our Company’s first Biologics Drug Substance Single Use Commercialisation Facility, playing an important role in helping to commercialise key medicines. The cutting-edge innovation and collaboration between our Company’s research and manufacturing teams will significantly accelerate the time it takes to bring a medicine to market for the benefit of patients around the world.
Required Skills:
Analytical Instrumentation, Change Control Processes, Computer System Validation (CSV), GMP Compliance, Metrology Equipment, Pharmaceutical Sciences, Regulatory Compliance, Vendor Management
Preferred Skills:
Current Employees applyHERE
Current Contingent Workers applyHERE
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):
Job Posting End Date:
07/28/2026*A job posting is effective until 11:59:59PM on the dayBEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFORE the job posting end date.
Requisition ID: R407945
