Manufacturing Process Specialist - Aseptic Drug Product - Dublin

Office/Project Location: Dún Laoghaire, Dublin

Employment Type: Minimum 12-Month Contract

Pay: Hourly Rate - €45-€50 per hour

Experience: 5+ years' cGxP experience in Aseptic Drug Product Manufacturing

Visa: EU passport or Stamp 4 visa required

Our client is a global biopharmaceutical leader specializing in innovative human therapeutics and state-of-the-art aseptic manufacturing.

A Senior Manufacturing Process Specialist / Lead is required for a 12-month contract to serve as a Subject Matter Expert (SME) on site and network initiatives at their biomanufacturing facility in Dún Laoghaire, Dublin.

Operating in a hybrid setup, the Specialist will oversee technical operations across aseptic Drug Product processes—including formulation, filling (syringe/vial), lyophilization, and capping—driving process efficiency, leading investigations, and ensuring compliance with Annex 1 standards.

Serve as the primary Subject Matter Expert (SME) and single point of contact for site and network projects, driving process improvement across aseptic manufacturing operations

Act as gatekeeper for critical process documentation, developing, reviewing, and updating SOPs, Electronic Batch Records (EBRs), training materials, and risk assessments

Direct operational initiatives to improve process reliability, throughput, and efficiency while proactively removing quality and safety error traps

Lead technical root-cause investigations into unplanned operational events, deviations, and non-conformances affecting safety, quality, or compliance

Define, implement, and track actionable Corrective and Preventive Actions (CAPAs) to prevent issue reoccurrence within agreed timelines

Monitor business performance metrics and process trends, using daily management systems to identify proactive improvement measures

Support operational teams during escalated technical issues and provide cross-functional subject matter expertise (Validation, Engineering, Quality, Manufacturing)

Provide input on modern techniques, state-of-the-art technology adoption, and aseptic operational change management

Coach, mentor, and cross-train team members within core technical areas

Requirements

Bachelor’s degree (Level 8) in Science, Bio-Engineering, Chemical Engineering, or a related discipline

5+ years' post-graduate experience in aseptic Drug Product manufacturing or high-volume cGxP biopharmaceutical operations

In-depth technical knowledge of aseptic processes: Parts Preparation, Formulation, Syringe/Vial Filling, Lyophilisation, and Capping

Strong working knowledge of regulatory cGMP frameworks, specifically Eudralex Volume 4, Annex 1 (Manufacture of Sterile Medicinal Products)

Demonstrated experience leading root-cause investigations, deviation writing, CAPA management, and change control procedures

Proven technical writing and documentation control capabilities within electronic quality management systems (eQMS)

Strong decision-making, stakeholder management, and cross-functional communication skills

Package

12-month contract duration

Hourly Rate €45-€50 depending on experience

Hybrid working structure (onsite in Dún Laoghaire / remote)

Exposure to a world-class biopharmaceutical manufacturing environment and global network initiatives

Contact

Karen McHugh is the consultant managing this position.

If you are Manufacturing Process Specialist interested in roles based in Dublin, you can contact Karen by e-mail at karen@jobcontax.com or phone +353-1-7978720 for a confidential chat.

JobContax do not send CVs to clients without candidate permission.

With over 50 years of technical recruitment experience, JobContax is the leading recruiter of Manufacturing Process Specialists in Dublin and Ireland.

Due to the large volume of applications, JobContax may not be able to respond to every individual.

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