Job Title: Technical Specialist
The company Career Wise Recruitment is seeking a highly skilled Technical Specialist to join their team in Cork.
This is a 12-month contracting position, ideal for individuals with experience as a Technical Specialist or Technical Scientist, or in a Validation role.
Key Responsibilities:
* Lead and support microbiological investigations, actively promoting a culture of continuous improvement and open communication.
* Perform routine area walkdowns and GEMBAs, driving strategy improvements related to contamination risks and microbiological hygiene.
* Define specific aseptic techniques for crucial process steps and review environmental monitoring and in-process sampling trends.
* Identify appropriate corrective and preventative actions and provide effective communication of adverse trends or activities.
* Collaborate with Process Microbiologists internally and across the network, accessing global microbiology support resources as needed.
* Review and approve relevant SOPs and WIs, ensuring consistency with GMP requirements and company standards.
Requirements:
* Bachelor's degree in a scientific or technical discipline, preferably microbiology.
* Minimum 3-5 years of experience in a pharmaceutical or GMP regulated Operations environment.
* Possess knowledge and experience of shop floor manufacturing processes and data analytics.
* Familiarity with FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.