Global Aseptic Process Engineer
On behalf of our client, we are looking for a senior Global Aseptic Process Engineer to join their global technical operations division. This position provides expert engineering oversight to the company's international manufacturing network and technical innovation centres.
The successful candidate will leverage extensive engineering principles, advanced technical data, and creative problem-solving to deliver complex sterile manufacturing capital projects and resolve intricate processing issues. You will drive the implementation of next generation manufacturing methods, lead engineering change initiatives, and offer vital technical guidance to multidisciplinary operational teams across various sterile production sites.
Key Responsibilities
- Act as the primary technical authority for advanced manufacturing programmes and equipment selection, presenting project updates and data to internal leadership and external bodies.
- Serve as a strategic technical advisor to executive management and manufacturing sites regarding the roll-out of advanced processing machinery, actively shaping project roadmaps.
- Take ownership of project deadlines, working interchangeably as the lead project engineer, stream lead, or senior technical contributor.
- Safeguard the integrity of sterile manufacturing setups on major capital installations through robust initial design, proactive risk profiling, and structured implementation. Ensure full visibility of failure modes or potential defects when modifying validated processes.
- Review and introduce emerging engineering technologies to overcome operational bottlenecks and elevate production reliability.
- Evaluate how engineering decisions affect the broader commercial lifecycle of specific products, ensuring technical solutions align with corporate commercial goals.
- Provide clear technical direction, peer reviews, and performance feedback to wider engineering and operational teams.
- Maintain rigorous adherence to internal corporate mandates, site-specific protocols, and international quality standards.
Required Experience and Qualifications
- Post-graduate qualification (Master's or PhD) in Chemical Engineering, Mechanical Engineering, or a highly relevant scientific discipline.
- A minimum of 8 years of dedicated engineering experience within the pharmaceutical sector, specifically focused on sterile process design, machinery configuration, and plant operations. Candidates must have exposure to at least one of the following:
- General sterile processing methods
- Upstream or downstream bioprocessing lines
- Sterile fill-finish operations
- A proven track record of acting as an industry subject matter expert with deep knowledge of sterile manufacturing constraints.
- Familiarity with cleanroom architecture, formulation processes, and plant utilities (such as HVAC and purified water systems).
- Direct experience facilitating or participating in FMEAs, formal risk analysis, and root-cause investigations within a regulated pharmaceutical environment.
- Strong stakeholder management and negotiation capabilities, with a proven knack for aligning conflicting technical viewpoints.
- Solid working knowledge of the international compliance frameworks governing the industry, particularly EMA and FDA standards.
- Prior experience operating within a centralised corporate engineering function or global technical services group is highly desirable.
