As a Senior Manufacturing Engineer, you will be a key technical leader driving operational excellence, implementing advanced automation, and leading complex tech transfers. If you thrive in a fast-paced, highly automated commercial environment where innovation meets strict regulatory standards, this is your next career milestone.
Key Responsibilities
- Process Optimization: Lead the troubleshooting, optimization, and continuous improvement of high-speed filling, formulation, and packaging equipment.
- Capital Projects & Tech Transfer: Act as the engineering lead for complex equipment modifications, new product introductions (NPIs), and system upgrades.
- Validation & Compliance: Author and execute validation protocols (IQ/OQ/PQ) and lead root-cause investigations (NC/CAPA) in compliance with FDA and EMA regulations.
- Cross-Functional Leadership: Mentor junior engineers and collaborate closely with Quality, Production, and Global Engineering teams to minimize downtime and ensure seamless tech transfers.
What You Bring
- Education: Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, or Biomedical).
- Experience: 5+ years of engineering experience within a regulated GMP environment (Biopharma, Pharmaceuticals, or Medical Devices).
- Technical Expertise: Strong hands-on experience with automated manufacturing systems, filling lines, clean utilities, or vision/packaging systems.
- Problem-Solving Skills: Proven track record in root-cause analysis (e.g., Fishbone, 5 Whys) and managing deviations/CAPAs.
- Mindset: A collaborative team player with excellent communication skills and the ability to influence cross-functional stakes.
