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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