Technical SME & Project Lead

Qualifications

• A third-level qualification in a STEM discipline, or equivalent relevant experience.
• Experience working in a biologics, pharmaceutical, medical device, or similarly regulated manufacturing environment.
• Typically, 2–5 years of relevant experience in a technical or manufacturing role.
• Strong understanding of regulatory requirements and industry standards relevant to aseptic manufacturing.
• Demonstrated technical expertise and the ability to apply scientific and engineering principles to manufacturing challenges.
• Strong communication and interpersonal skills, with the ability to work effectively in cross-functional project teams.
• Ability to work independently, take initiative, define functional requirements, and deliver practical solutions.
• Strong collaboration and team leadership skills, with the ability to work effectively across departments and organizational levels.
• Experience with aseptic filling operations for vials, cartridges, or syringes.
• Experience with sterilization, cleaning, depyrogenation, lyophilization, or cleanroom technologies.
• Experience supporting change controls, CAPAs, risk assessments, validation, or process improvement projects.
• Experience working with external vendors, consultants, and global technical teams.