Summary:
Our client, a biopharmaceutical company located in Louth, is seeking a
Manufacturing Process Specialist
to provide hands-on technical support within the Drug Substance manufacturing team. The ideal candidate will support cell culture, bioreactor, and downstream operations, contributing to successful product launch, commercial manufacturing, and continuous improvement initiatives. The successful candidate will also work closely with Operations, Quality, Engineering, and MS&T teams in a fast-paced GMP environment.
Responsibilities:
* Provide technical support to Drug Substance manufacturing operations, including cell expansion, bioreactor, and downstream processes.
* Support equipment commissioning, qualification, and validation activities, including FAT, SAT, IQ and OQ.
* Coordinate and execute technical deliverables to support project execution and product launch.
* Provide on-the-floor technical support during commercial manufacturing operations.
* Lead or support manufacturing investigations, root cause analysis, and CAPA development in collaboration with cross-functional teams.
* Support batch disposition activities by providing SME input for technical comment resolution.
* Contribute to continuous improvement initiatives to enhance compliance, quality, and manufacturing capability.
* Support process and quality improvements through the application of Lean Six Sigma and risk-based tools.
* Prepare, review, and update GMP documentation, including batch records, SOPs, and technical reports.
* Work in partnership with MS&T to provide technical leadership and knowledge sharing within the Drug Substance organisation.
Qualifications & Experience:
* Bachelor's degree in Engineering, Science, or a related technical discipline.
* Minimum of 3 years' experience in a GMP environment within biological, vaccine, or pharmaceutical manufacturing.
* Experience supporting Drug Substance operations, including cell culture and downstream processing.
* Hands-on experience with equipment qualification and manufacturing support activities.
* Strong experience in deviation management, investigations, and data-driven root cause analysis.
* Knowledge of GMP requirements and regulatory guidelines, including Annex 1, desirable.
* Experience in start-up or project-based manufacturing environments is advantageous.
* Proven technical writing capability and attention to detail.