Job Description

A fantastic opportunity has arisen for a Sr. Spclst, Operations, Tech Supply.

Reporting into the Biotech Dublin Upstream Technical Operations Lead, the Senior Specialist, Operations will be a key technical subject matter expert ensuring the facility is operationally ready for commercial large-scale production of Drug Substance.

The role will deliver a diverse range of technical support to the Drug Substance Business. This will include leading technical investigations within the Integrated Process Team and supporting significant projects across the site.

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

• Work with the Integrated Process Team (IPT) to ensure the effective and efficient on-time delivery of batch production within the IPT area.
• Establish oneself as a key point of contact for designated upstream process workstreams as assigned.
• Provide ongoing coaching to cross functional team members, to share process, engineering, and maintenance best practices.
• Provide technical, process and engineering expertise within a wide range of projects, such as the introduction of new equipment and processes.
• Work with Technical groups across the site and network, foster technical excellence to be a differentiating advantage.
• Support Upstream Operations teams to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. Safety metrics, Production Plan, Overall Equipment Effectiveness, compliance and team training.
• Author and manage Deviation and Change Control generation.
• Assist in the investigation and troubleshooting of issues and the development and implementation of robust corrective and preventative actions.
• Review trends for CAPA Effectiveness.
• Coach, and help develop a pool of investigators within the Upstream IPT.
• Support generation of SOPS/Electronic Batch Records for production and facilitate reviews as necessary.
• Accountable for protocol generation, report authoring, execution, oversight and approval.
• Participate in site audits as deemed necessary.
• Drive a culture of Continuous Improvement by deploying Six Sigma and lean manufacturing tools.

What skills you will need:

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

• Degree or 3rd level qualification (Science, Engineering).
• At least 8+ years experience in the Pharmaceutical industry (preferably experience in Drug Substance, Upstream operations).
• Experience in a highly regulated GMP Manufacturing Environment in a technical or manufacturing support role.
• Knowledge and experience in process optimization, technical transfer of products and extensive knowledge of Validation requirements.
• Demonstrated leadership and change management skills with a continuous improvement focus.
• Proven track record of delivering high performance through development and coaching of a team.
• Demonstrated excellent problem solving capabilities.
• Knowledge of and experience in applying Six Sigma and Lean methodologies.
• Desirable evidence of Continuous Professional Development

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:

04/10/2025

*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.