MSAT Support Engineer
ROLE OVERVIEW
The Junior MSAT Engineer will provide hands-on support to the Manufacturing Science & Technology (MSAT) team, with a focus on Performance Qualification (PQ) documentation for key manufacturing equipment such as autoclaves, parts washers, and other associated systems. This is a support-function role suited to someone early in their MSAT or process engineering career who is looking to build a long-term career in pharmaceutical manufacturing.
KEY RESPONSIBILITIES
- Support the preparation, execution, and documentation of Process Qualification (PQ) protocols and reports for equipment including autoclaves, parts washers, and related systems
- Assist Senior MSAT Engineers with IQ/OQ/PQ documentation and equipment qualification lifecycle activities
- Support data collection, compilation, and review for qualification protocols and summary reports
- Assist in coordinating with QA, Manufacturing, and Engineering teams to ensure qualification documentation aligns with GMP requirements
- Support investigation and resolution of technical or documentation discrepancies identified during qualification activities
- Assist with change control, deviation, and CAPA documentation as required
- Maintain accurate records and support audit/inspection readiness for qualification documentation
- Support ad-hoc process and technical documentation needs for the wider MSAT team
REQUIREMENTS
- Degree in Chemical Engineering, Biotechnology, Life Sciences, Pharmaceutical Engineering, or related discipline
- 0-3 years of experience in a GMP-regulated pharmaceutical manufacturing environment (internship or entry-level experience considered)
- Basic understanding of equipment qualification concepts (IQ/OQ/PQ) is an advantage
- Strong attention to detail and documentation accuracy
- Good communication and coordination skills, with the ability to work closely with senior engineers and cross-functional teams
- Proactive, eager to learn, and comfortable working in a fast-paced GMP manufacturing environment