Hamlyn Williams is working with an industry-leading pharmaceutical company seeking a Technical Services Specialist to provide technical leadership and support for sterile fill-finish drug product manufacturing in County Westmeath. This role is key to new product introductions (NPI), technology transfers, process troubleshooting, and continuous improvement.
Key Responsibilities:
* Provide technical expertise across manufacturing operations, including formulation, sterile filtration, filling, and visual inspection.
* Act as a Subject Matter Expert (SME), supporting technology transfers, process validation, and start-up activities.
* Lead deviation investigations and process troubleshooting, collaborating with Process Development, Quality, and Manufacturing teams.
* Assess and introduce single-use systems, focusing on extractables and leachables.
* Author and review critical documentation, including protocols, validation reports, and technical assessments.
* Support the introduction of new raw materials and consumables, managing materials lists, BOMs, and specifications.
* Review and manage change controls to ensure product quality and regulatory compliance.
* Provide on-the-floor technical support and oversee the execution of technical studies.
* Ensure compliance with cGMP, EHS, and regulatory standards, supporting internal and external audits.
Qualifications & Experience:
* Degree in Biochemistry, Biology, Chemistry, or Engineering (Chemical, Mechanical).
* Experience in technical services, drug product manufacturing, or process development.
* Strong knowledge of sterile manufacturing processes and single-use systems.
* In-depth understanding of cGMP requirements for clinical and commercial manufacturing.
* Proven skills in problem-solving, troubleshooting, and technical documentation.
* Experience with technology transfers and change control processes.
Seniority level: Mid-Senior level
Employment type: Contract
Job function: Engineering, Production, and Quality Assurance
Industries: Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Biotechnology Research
If you are interested in this role please submit an application, and feel free to contact me over LinkedIn messenger or at m.mayer@hamlynwilliams.com
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