We are seeking a high-calibre Senior Process Engineer to join a leading global pharmaceutical organization. Operating within the MS&T team, you will provide the technical and scientific expertise required to support sterile manufacturing, drive technology transfers, and lead continuous improvement initiatives.
This role requires a curious, analytical mindset and a track record of developing innovative solutions to complex technical challenges in a highly regulated environment.
Key Responsibilities
- Tech Transfer & Lifecycle Management: Lead technology transfer projects, alternative API qualifications, process scale-ups, and hold-time extensions.
- Validation & Qualification: Plan, coordinate, and execute exhibit and Process Performance Qualification (PPQ) batches, alongside drafting cleaning validation documentation.
- Investigations & Data Analysis: Lead manufacturing quality investigations and product impact assessments. Design Quality by Design (QbD) experiments and execute scientific protocols to resolve manufacturing deviations.
- Process Optimization: Methodically analyze multi-source technical data to monitor continuous process verification, address trends, and reduce product variability.
- Technical Writing: Author high-quality scientific protocols, reports, and data reviews to deliver sound, actionable recommendations.
- Leadership & Collaboration: Act as a self-starter to manage projects to completion, cross-functionally influence site teams, and mentor junior team members.
Candidate Profile
Minimum Qualifications:
- Education: Bachelor's degree in a relevant Scientific or Engineering discipline.
- Experience: Minimum of 3 years of experience within the pharmaceutical industry, specifically inside a sterile facility.
- Technical Mastery: Proven track record in Process Performance Qualification (PPQ), manufacturing investigations, and CAPA implementation.
Preferred Experience:
- Hands-on experience with aseptic filling machines and pharmaceutical compounding.
- Working knowledge of single-use systems.
