Thermal Validation & CQV Engineer

Job Description
We are seeking an experienced  Thermal Validation & CQV Engineer  to lead and execute  Commissioning, Qualification, and Validation (CQV)  activities across facilities, utilities, systems, and equipment in a  GMP-regulated  environment.

You will be responsible for developing and performing  thermal validation  for sterilization and decontamination systems, ensuring compliance, accuracy, and inspection readiness throughout the validation lifecycle.

Key Responsibilities

Lead and execute CQV activities  for facilities, utilities, and process equipment across routine operations and capital projects.

Author and review  risk‑based C&Q documentation: FCCA, RTM, DQ, CTP, IOQ/PQ, EM PQ, smoke studies, and  thermal validation protocols  (heat penetration, cycle development, ranking studies; moist heat, dry heat, VHP).

Plan and perform FAT/SAT , critical test plans, and CSV activities where applicable (equipment/automation interfaces).

Perform thermal validation using Kaye AVS v1.4+ (or equivalent):

Thermocouple preparation, calibration, and placement.

BI (Biological Indicator) handling and exposure.

Cycle execution, data capture, and analysis.

Cycle optimization and performance qualification.

Validate sterilization and decontamination systems , including autoclaves, isolators, tunnels, ovens, vial washers, SIP systems, biowaste and decontamination autoclaves, and sanitization systems.

Support  annual validation programs : smoke studies, sterilizer/isolator/tunnel/oven/SIP requalification, and temperature mapping of controlled units.

Investigate and document deviations  and non‑conformances, perform root cause analysis, and generate  inspection‑ready validation reports .

Own documentation and scheduling , including change controls, SOPs/WIs, PM task lists, and regular reporting via Excel/PPT (Teams/Email).

Collaborate closely with Operations, MSAT, Automation, Engineering & Maintenance, and Quality teams to ensure  GMP compliance and inspection readiness .

Promote  continuous improvement  and provide  mentorship  and guidance to junior validation staff.

Tools & Platforms

Kaye AVS v1.4+  (or equivalent) for thermal validation and data acquisition.

Kneat  (paperless validation) and  Veeva Vault  for documentation management.

Profile Requirements
Education

Bachelor’s degree in Engineering, Pharmaceutical Sciences, Microbiology, or a related discipline.

Experience by Level

Consultant / Intermediate:  3–6 years of CQV/CSV/thermal validation experience in a GMP pharmaceutical or biotech environment.

Senior:  6–10+ years with protocol/report ownership and cross‑functional leadership.

SME / Lead:  10+ years leading complex validation programs and supporting inspections.

Technical Expertise

Strong hands‑on experience with:

Thermal cycle development, heat penetration studies, and BI logistics.

Temperature mapping  and  smoke studies.

IOQ/PQ execution  and requalification activities.

Solid understanding of  FAT/SAT ,  risk‑based validation ,  FCCA ,  RTM , and  CSV  principles.

Proficiency in  Kaye AVS  systems and familiarity with  Kneat  and/or  Veeva Vault .

Strong knowledge of  GMP/GLP/GDP/EHS  and  ALCOA+ data integrity  standards.

Excellent skills in  technical writing ,  data/statistical analysis , and  problem‑solving .

Nice to Have

Expertise in  VHP/depyrogenation  and  SIP/CIP  qualification (complex/custom systems).

Experience with isolators, tunnels, vial washers, and biowaste systems.

Exposure to large capital projects and site‑wide validation strategies.

Experience mentoring or upskilling junior engineers; continuous improvement mindset.

Amaris Consulting promotes equal opportunities. We are committed to bringing together people from diverse backgrounds and creating an inclusive work environment. In this regard, we welcome applications from all qualified individuals, regardless of sex, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

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