Technical Services Specialist

Introduction to Role:

Are you ready to turn deep process expertise into dependable, compliant manufacturing that gets medicines to patients faster? This role places you at the technical heart of our sterile fill-finish operations in Athlone, accelerating new product introductions and strengthening routine supply.

You will lead technology transfer execution, design and run process studies, and transform data into actions that underpin process qualification and regulatory submissions. Working side by side with Manufacturing, Engineering, Automation, Quality, and Process Development, you will troubleshoot in real time, embed best practices for single-use systems, and ensure materials and documentation are always transfer-ready.

How would you apply your experience to de-risk transfers and elevate process performance from day one?

Accountabilities:

• Drug Product Technical Leadership: Provide significant technical expertise across fill-finish operations at the Athlone facility to ensure robust, compliant performance and reliable supply.
• Process Subject Matter Expertise: Act as SME for commissioning, automation and manufacturing operations, guiding equipment readiness and process control strategies.
• Technology Transfer Ownership: Plan and deliver technology transfer milestones for new products, from gap assessments and data capture to process qualification.
• Process Monitoring and Data Packages: Build process data packs, monitor performance, and convert trends into targeted improvements in yield, quality and throughput.
• Study Design, Execution and Reporting: Generate protocols, oversee execution and sample reconciliation, and author clear, decision-focused technical reports.
• Deviation and Troubleshooting Leadership: Lead cross-functional investigations with Process Development, Manufacturing and Quality to identify root causes and implement corrective and preventative actions.
• Single-Use Systems Stewardship: Introduce and assess single-use systems, including extractables and leachables evaluations to protect product quality and patient safety.
• Documentation and Validation: Author and review process descriptions, gap assessments, validation documentation and strategy papers that withstand regulatory scrutiny.
• Materials and BOM Integration: Support introduction of new raw materials and consumables, including materials lists, Bills of Material updates and specifications.
• Cross-Functional Orchestration: Collaborate with Quality, Supply Chain and Manufacturing Operations to align material availability and release with transfer and production timelines.
• Change Control Management: Lead key process changes through the change control system and perform technical impact assessments on product quality, safety and efficacy.
• On-the-Floor Support: Provide immediate technical support during manufacturing to enable safe, right-first-time execution.
• Compliance and Audit Readiness: Implement corporate standards, liaise with global groups, and provide technical support during internal and external audits.
• EHS and cGMP Commitment: Ensure strict adherence to site EHS policy, cGMP and all applicable regulations.

Essential Skills/Experience:

• Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field.

• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation, to:

• Use a computer;
• Engage in communications via phone, video, and electronic messaging;
• Engage in problem solving and non-linear thought, analysis, and dialogue;
• Collaborate with others;
• Maintain general availability during standard business hours.

Desirable Skills/Experience:

• Experience in technical services support in drug product manufacture and/or process development and/or manufacturing support.

• Experience in relevant unit operations including formulation, sterile filtration, filling and visual inspection activities of the drug product manufacturing process.

• Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices.

• Experience of technology transfers and implementing new clinical and commercial biopharmaceutical manufacturing processes.

• Prior experience in the use of single-use systems (single-use mixers, manifolds) would be an advantage.

• Ability to present and defend the technical aspects of manufacturing operations.

• Self-motivated, detail-oriented, enjoys an interactive environment and works well within a team.