Development Engineer (Snr Specialist)

MSD; Ireland; Hybride; EUR 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Hybrid work model

Résumé du poste

Merck & Co., Inc. in Ballydine, Co. Tipperary invites a Development Engineer to steer process development, scale-up, and tech transfer for commercial products.

The role leads cross-functional teams to ensure efficient, compliant transitions to manufacturing and robust ongoing process improvement. Key responsibilities include leading validation, troubleshooting, and project management across IPTs, with focus on cGMP compliance and QRM.

Qualifications

• BSc/BEng in Chemical Engineering or related
• MSc/PhD is beneficial
• Strong understanding of pharm process development and tech transfer

Responsabilités

• Lead design, scale-up, and transfer of new solid oral dosage manufacturing processes.
• Drive cross-functional QA, risk assessments, investigations and process improvements.
• Lead validation programs to meet cGMP and global regulatory expectations.
• Provide troubleshooting support for multiple active manufacturing processes.
• Manage projects with clear scope, risks, and accountabilities for successful tech transfers.
• Apply Lean Six Sigma tools to drive efficiency and optimization.
• Ensure QMS and regulatory compliance across engineering operations.

Connaissances

Process Development

Tech Transfer

Project Leadership

Quality & Compliance

Formation

BSc in Chemical Engineering

BEng in Chemical Engineering

MSc or PhD (beneficial)

Description du poste

Job Description

An amazing opportunity has arisen for a Development Engineer to join our Commercialisation Development and Supply (CDS) team in Ballydine, Co. Tipperary. Reporting to the CDS OSD Commercialisation Technical Lead, you will work as a key technical leader within the Pharmaceutical CDS group. You will be responsible for final pharmaceutical dosage form process development activities to support the commercialization of new products, implementing them into production, and driving process improvements in conjunction with R&D and the manufacturing Integrated Process Teams (IPT). You will assemble and lead project technical teams for new process and product launches, ensuring that pharmaceutical processes are transferred to the IPT efficiently, compliantly, and completely.

• Process Development & NPI Leadership Lead the design, scale-up, and transfer of new solid oral dosage (OSD) manufacturing processes. This includes planning and executing characterization and design space studies, providing critical technical oversight for clinical and primary stability batch manufacture, and translating complex development data into robust, validated commercial processes.
• Cross-Functional Team Leadership Lead and participate in high-performing, cross-functional teams to drive Quality Risk Assessments (QRA), complex Quality Investigations / Notifications, Safety Assessments (HAZOPs), and strategic process improvement initiatives.
• Validation Excellence Author, execute, and lead process and cleaning validation programs to guarantee seamless compliance with cGMP, cleaning validation requirements, and global regulatory expectations.
• Technical Support & Troubleshooting Provide high-level scientific and technical troubleshooting support to the IPT for multiple active manufacturing processes, evaluating raw materials, and ensuring process robustness.
• Project Management Operate effectively as a project leader, using robust planning to identify needs, priorities, risks, and accountabilities to ensure successful outcomes for new product introductions and technology transfers.
• Continuous Improvement Pioneer the application and sharing of cutting-edge techniques and processes. Identify and implement improvements in processes and business systems, utilizing Lean Six Sigma (LSS) tools to drive efficiency and optimization.
• Quality & Compliance Ensure all engineering operations comply with cGMP, Environmental, and Health & Safety regulations. Act as a Sub-System Owner for various Quality Management System (QMS) areas, ensuring that all processes conform to site, divisional, and corporate quality standards.

• BSc, BEng, or higher in Chemical Engineering, Chemistry, Natural Sciences, or a related discipline. An advanced degree (MSc, PhD) is beneficial.
• A minimum of 6 years of post-graduation experience in a pharmaceutical process development, manufacturing, and technology transfer environment.
• Strong, demonstrated understanding of process chemistry, formulation technology, and engineering principles specifically applied to solid oral dosage (OSD) platforms.
• Expertise in process development, scale-up, technology transfer, and cleaning validation.
• In-depth knowledge of cGMPs, global regulatory expectations, and Quality Risk Management (QRM).
• Proven experience with deviation management systems, root-cause analysis (8-Step methodology), and production operations.
• Excellent written and verbal communication, with a proven ability to present complex technical data to diverse audiences.
• Demonstrated capability to lead project teams and work collaboratively across functional boundaries.
• Strong project management, problem-solving, and time-management skills.
• Ability to work in partnership with all plant departments, including PCT, process engineering, central engineering, and global manufacturing division groups.

Ballydine is the primary Drug Substance commercialisation hub within the network, where new processes are scaled and transitioned to commercial manufacture. The site supports clinical and commercial API supply and the transfer of processes and technologies across internal manufacturing sites and external partners.

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. 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,

Required Skills

Chemical Engineering, Continuous Improvement Techniques, Drug Product Development, Good Manufacturing Practices (GMP), New Product Introduction (NPI), Pharmaceutical Process Development, Project Management, Regulatory Compliance, Solid Dosage Forms, Technical Transfer

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

Flexible Work Arrangements

Hybrid

Job Posting End Date

11/18/2026

• 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.

Requisition ID R423602