We are seeking a high-caliber Manufacturing Process Specialist to serve as a technical linchpin within a core Business Unit. This is a critical "boots-on-the-ground" technical role, perfect for an engineer or operations specialist who thrives on optimizing complex processes, ensuring rigorous GMP compliance, and driving operational excellence.
Key Responsibilities
- Process Architecture: Develop and refine manufacturing and cleaning recipes (MBR/Recipe management) to ensure peak efficiency.
- Operational Intelligence: Own the business unit's performance metrics. You will design and manage dashboards and scorecards that drive management decision-making.
- Quality & Safety Leadership: Lead end-to-end investigations (Complaints, EHS, NCPs), performing deep-dive root cause analysis and implementing robust CAPAs.
- Change & Risk Management: Navigate the Change Control system and contribute technical expertise to HAZOP studies to "design out" process risks.
- Continuous Improvement: Proactively identify bottlenecks and optimization opportunities through trend analysis and internal audits.
- Strategic Rework: Develop specialized reprocessing strategies, test methods, and technical protocols.
Candidate Profile
The ideal candidate is a disciplined communicator with an "engineer-mindset"-organized, deadline-driven, and highly analytical.
Technical Requirements
- Experience: Minimum of 5 years in a manufacturing operations or process-centric role.
- Industry Pedigree: Direct experience in Aseptic/Sterile environments is highly preferred. We will also prioritize candidates from API or Biologics/Bio-Pharma backgrounds.
- Education: A Third-level degree in Engineering, Science, or a related technical discipline.
- Methodology: A strong grasp of LEAN manufacturing principles is a significant advantage.
Preferred Backgrounds
We are looking for individuals currently functioning as a Process Engineer, Operations Specialist (Micro/Manufacturing), or Process Specialist. (Note: This is a process/ops role; it is not suitable for those seeking laboratory/analytical roles).
