Job Description

A fantastic opportunity has arisen for a Senior Specialist, Engineering to join the companies Analytical Science Team at Dunboyne.

Our Analytical Science Team is committed to ensuring analytical methods are robust and ready for quality control (QC), facilitating end-to-end method lifecycle management.

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

The successful candidate will be responsible for a diverse range of tasks including, but not limited to: Analytical Method Verification/Validation and Technical Support:

Conduct compendial and non-compendial analytical method verification/validation for drug substances and raw materials.Provide analytical method support for new product introductions, including new technology introduction.Involved in the development, troubleshooting, and optimization of analytical methods to ensure their robustness and QC readiness.Assess and implement changes to existing methods and equipment, including technical troubleshooting in cross-functional investigations.Perform technical reviews to evaluate the impact of new/revised global test methods and compendial changes as part of a cross-functional team.Contribute to the assessment of analytical methods and equipment regarding proposed compendial changes.Support sister sites during transfers and standardization efforts.Participate in internal and external audits and inspections, ensuring department compliance and readiness.Strong understanding of industry standards and GMP systems.Oversee the Performance Qualification (PQ) aspect of equipment qualification, supporting Installation Qualification (IQ) and Operational Qualification (OQ) as needed

What skills you will need:

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

Bachelor’s degree in Biochemistry, Cell Biology, Analytical Science, or a related field; Master’s or PhD preferred.Minimum of 5 years of experience in analytical method introduction and qualification within the biopharmaceutical and/or pharmaceutical industry, with a comprehensive understanding of the end-to-end manufacturing process.Proficient in analytical methods, including microbial methods, HPLC, cGE, ELISA, Bioassays, PCR, compendial methods, and rapid microbiological methods (RMM).Knowledge of ICH, USP, and other compendial chapters required for method transfer and validation, particularly in late-stage method development, validation, and transfer.Strong project management and stakeholder management skills, with a proven ability to influence internal and external stakeholders.Demonstrated capability to work collaboratively as part of a team and independently to ensure prioritization and progress.Excellent problem-solving skills, including risk management, decision-making, and troubleshooting abilities.

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.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model

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):

Job Posting End Date:

03/8/2025

*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.

Requisition ID:R334511