Development Engineer (Snr Specialist)

Description

The company's Commercialisation Development and Supply (CDS) team in Ballydine, Co. Tipperary, is hiring a Development Engineer at senior specialist level.

You report to the CDS OSD Commercialisation Technical Lead and act as a senior technical leader in the pharmaceutical CDS group.

You lead final pharmaceutical dosage form process development to bring new products to market, move them into production, and drive process gains, working with R&D and the manufacturing Integrated Process Teams (IPT).

You build and run project technical teams for new process and product launches so that processes reach the IPT on time, within compliance, and complete.

Ballydine is the main Drug Substance commercialisation hub in the network, where new processes are scaled up and moved to commercial manufacture. The site supplies clinical and commercial API and transfers processes and technologies to other internal sites and external partners.

Responsibilities

• Lead the design, scale-up and transfer of new solid oral dosage manufacturing processes, including planning characterisation and design space studies.
• Provide technical oversight for clinical and primary stability batch manufacture, and turn development data into robust, validated commercial processes.
• Lead and join cross-functional teams on Quality Risk Assessments, complex quality investigations and notifications, safety assessments (HAZOPs), and process improvement work.
• Write, run and lead process and cleaning validation programmes that meet cGMP, cleaning validation rules and global regulatory expectations.
• Give senior scientific and technical troubleshooting to the IPT across several active manufacturing processes, including raw material evaluation and process robustness.
• Lead projects with solid planning to identify needs, priorities, risks and owners, so that new product introductions and technology transfers succeed.
• Introduce and share advanced techniques and processes, and improve process and business systems using Lean Six Sigma (LSS) tools to raise efficiency.
• Make sure all engineering work complies with cGMP, environmental, and health and safety regulations, and act as Sub-System Owner for QMS areas so processes meet site, divisional and corporate quality standards.

Requirements

• A BSc, BEng or higher in chemical engineering, chemistry, natural sciences or a related field.
• At least 6 years of experience after graduation in pharmaceutical process development, manufacturing and technology transfer.
• Demonstrated understanding of process chemistry, formulation technology and engineering principles as applied to solid oral dosage platforms.
• Experience in process development, scale-up, technology transfer and cleaning validation.
• Deep knowledge of cGMP, global regulatory expectations and Quality Risk Management (QRM).
• Proven track record with deviation management systems, root-cause analysis (8-Step methodology) and production operations.
• Clear written and spoken communication, with proven skill presenting complex technical data to varied audiences.
• Proven ability to lead project teams and work across functions.
• Strong project management, problem-solving and time management skills.
• Ability to work with all plant departments, including PCT, process engineering, central engineering and global manufacturing division groups.
• Skills tagged for the role: chemical engineering, continuous improvement techniques, drug product development, GMP, NPI, pharmaceutical process development, project management, regulatory compliance, solid dosage forms and technical transfer.
• An advanced degree (MSc, PhD) is beneficial.

Conditions

Regular employee position with a hybrid work arrangement, based in Ballydine, Co. Tipperary.

The posting does not state visa sponsorship, relocation, travel requirements, shift pattern, driving licence or hazardous material details.

The posting closes on 11/18/2026 and is effective until 11:59:59 PM on the day before that date.

The company does not accept unsolicited help from search firms without a written agreement for this specific role.