About the job Process Engineer – K Mapping (Thermal Mapping)
A Leader in Life science Manufacturing Technology solutions, we are looking for top talent to be part of the dynamic team and drive the growth of the business.
Job Title: Process Engineer – K Mapping (Thermal Mapping)
Industry: Pharmaceutical / Biotech / Life Sciences
Experience: 4–8 Years
Location: Site-based
Role Overview
We are seeking Process Engineers with hands-on experience in K Mapping (Thermal Mapping) to support qualification and verification activities across GMP pharmaceutical manufacturing environments. The role focuses on thermal distribution and heat mapping studies for incubators, bioreactors, skids, and associated process equipment, ensuring compliance with regulatory and site requirements. The engineer will work closely with CQV, QA, and Manufacturing teams during execution-intensive mapping campaigns.
Key Responsibilities
- Execute K Mapping / Thermal Mapping studies for GMP process equipment, including incubators, bioreactors, skids, and supporting systems.
- Plan and support mapping protocols, including sensor placement, test conditions, and acceptance criteria.
- Perform on-site execution, monitoring temperature distribution, heat penetration, and stability across operating ranges.
- Review, analyze, and interpret mapping data to identify hot/cold spots and compliance gaps.
- Support deviation investigations and re-mapping activities where acceptance criteria are not met.
- Prepare and review mapping reports, raw data packages, and summary documentation.
- Coordinate closely with CQV, QA, Manufacturing, and Utilities teams during mapping execution.
- Ensure activities align with GMP, EU Annex 1, and site qualification standards.
Required Qualifications & Experience
- Bachelors degree in Chemical, Mechanical, or Process Engineering (or related discipline).
- 4–8 years of experience supporting K Mapping / Thermal Mapping activities in GMP environments.
- Hands-on experience with temperature mapping of process equipment (incubators, bioreactors, skids, vessels).
- Strong understanding of thermal principles, sensor placement strategies, and acceptance criteria.
- Experience working in live manufacturing or brownfield facilities.
- Familiarity with GMP documentation, deviations, and change control processes.
Nice to Have
- Experience with sterile / aseptic manufacturing facilities.
- Exposure to data loggers and mapping tools (e.g., Ellab, Kaye, or equivalent systems).
- Prior experience supporting regulatory inspections or audit readiness activities.