Quality Engineer (Aseptic Lead)

We at Orion Group are currently recruiting a Quality Engineer (Aseptic Lead) on behalf of one of our Multinational Biopharmaceutical Clients in County Carlow to work on an 11-month contract.

Role Description

Provides leadership, cross-functional development and technical expertise to operations team on the aseptic manufacture of biologics and vaccines. Ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to our customers.

Role Functions

• Responsible for the coaching, mentoring and training of the operations teams on primary aseptic manufacturing, clean room management and behaviours
• Assess the maturity of the teams aseptic and clean room ability.
• Serve as site lead in Sterile Council and Sterile CoP and provide input to network sterile standards and guidelines.
• Assess team member training/development needs and ensure all receive appropriate training, resources and programs to develop technical and other skills to effectively complete their jobs.
• Develop and maintain training programs.
• Assist the team with development of objectives and ensures alignment with site goals.
• Foster an environment that allows for progressive, continuous improvement of skills and honest, open feedback focused on how/why to complete aseptic manufacturing process.
• Provide ongoing formal and informal feedback on the Aseptic qualification of the IPT operations team.
• Oversee coordination of resources to implement suggestions/ideas of merit within the clean room areas.
• Effectively lead the media fill (Process Simulation) development and execution.
• Responsible for contributing to the Cleanroom Operation and contamination control procedures in IPT including but not limited to: Cleaning and Sanitisation, Garbing, People, Material and Process Flow, and Segregation Procedures.
• Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
• Work collaboratively to drive a safe and compliant culture.
• May be required to perform other duties as assigned.

Qualifications and Experience

• 5 years operations experience in a sterile manufacturing environment
• Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.