Job Description

An amazing opportunity has arisen for an CDS API Specialist.

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

Take direct ownership of manufacturing equipment and product processes.

Lead process and equipment optimisation in order to sustain and improve product quality, yields and through-put. Make recommendations and implement measures to improve production systems, equipment performance, yields and quality of product.

Interface with new product development groups to integrate new products into the facility either as new process development entities or as product transfer from another manufacturing facility. Supporting migration of process knowledge for product technical transfers from facility.

Execute process development on existing products or new late stage clinical products including scale up to plant equipment.

Identify continuous improvement activities and lead/participate in cross-functional teams to implement these opportunities. Support activities in the areas of cost reduction, process efficiency and operational excellence.

Provide on-the-floor technical support to the Production Team Leaders for process/equipment optimization and troubleshooting.

Provide technical support to production and cleaning campaigns and lead for all process and cleaning recipe management and documentation preparations.

Lead the facility preparations in support of cleaning and turnaround.

Ensure that all safety, quality and environmental compliance goals are achieved, including thoroughly investigating deviations and ensuring appropriate corrective actions are identified and implemented in full.

Have an expert level of knowledge in selected areas of Operations (i.e. Safety, Launch Platform, Dry End, Recipe Management, Turnaround etc).

Manage procedures/sops and business practices associated with the assigned area, including continuous improvement.

Lead a significant project or a team of Engineers in support of achievement of Operations objectives. Provides the manufacturing input into major capital projects.

What skills you will need:

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

An honours degree in Chemical Engineering or related discipline.

Minimum 3 year’s experience in API production or related environment

Ability to plan, prioritise and effectively manage time, meet deadlines and produce quality deliverables.

Excellent verbal and written communication skills.

Conflict resolution and problem-solving skills.

Decision making - analyses issues from different points of view, able to draw accurate conclusions from analyses to support decision making and make timely decisions.

Openness to and ability to affect change.

High personal integrity, credibility and energy.

Ability to identify areas for improvement either in business systems or product development. Demonstrated ability to be self-driven with respect to implementing identified improvement initiatives.

First established in 1976, our Ballydine facility develops and supplies the active ingredients and final formulated product for a range of innovative medicines at its manufacturing and R&D facilities. Ballydine was our Company’s first site in Ireland, the Ballydine site is our Company’s primary small molecule pipeline commercialisation facility globally, operating as a European hub for quality, manufacturing, and engineering. Its highly skilled teams lead the way in the development of new medicines, including innovative treatments for Hepatitis C, HIV and immuno-oncology, the site exports to over 25 countries around the world.

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.

Required Skills:

Adaptability, Change Control Management, Data Analysis, Equipment Troubleshooting, Good Manufacturing Practices (GMP), Lean Manufacturing, Personal Initiative, Process Optimization, Professional Integrity, Project Management, Root Cause Analysis (RCA), Technical Writing, Technology Transfer, Vaccine Manufacturing, Writing Technical Documents

Preferred Skills:

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:

04/25/2026

*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.

Spclst, Engineering

Job Description