Process Engineer – K Mapping
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Job Location:
Monthly Salary:
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
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: 48 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).
- 48 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.
Key Skills
- Lean Manufacturing
- Six Sigma
- Distributed Control Systems
- Continuous Improvement
- Process Improvement
- Minitab
- Root cause Analysis
- Process Engineering
- cGMP
- Kaizen
- Programmable Logic Controllers
- Manufacturing
