Senior Validation Engineer – GMP & CQV

Strive pharmacy; Florida; On-site; USD 105,000 - 115,000; Full time

Benefits offered by this job

Employer-paid healthcare

Free Strive compounded medications

Paid time off

Sick time

FSA and HSA options

Parental leave

401(k) with employer matching

Life insurance

Vision and dental insurance

Veterinary insurance

Job summary

Strive Pharmacy in Alachua, FL is seeking a Validation Engineer III to manage end-to-end validation documentation within a GMP-regulated facility. You will bridge operations, validation execution, and project delivery, ensuring all lifecycle docs meet global standards.

The role requires 10+ years of engineering/validation experience, expertise in ASTM E2500, ISO cleanroom classifications, and proficiency with AutoCAD, MS Project/Smartsheet, and CMMS systems. On-site work Monday–Friday.

Qualifications

• B.S. in Chemical, Mechanical, Bio-Engineering, or related engineering field.
• 10+ years of engineering and validation experience in a GMP-regulated environment.

Responsibilities

• Develop and review technical packages and turnover packages (P&IDs, PFDs, mass/energy balances).
• Author URS and FDS for new process equipment and automation systems.
• Oversee integration of new equipment into facility utility infrastructure (HVAC, Electrical, Clean & Non-Clean).
• Validation Ownership: align activities with Validation Master Plan and QMS.
• Initiate validation Change Controls; perform RCA and lead investigations for deviations.
• Evaluate vendor-supplied validation and engineering docs; gap analyses vs cGMP/regulatory standards.
• Manage C&Q through handover to Operations; coordinate with Metrology to onboard new instrumentation.

Skills

Validation engineering

GMP compliance

Technical validation

Quality systems

Regulatory standards

21 CFR 11

Risk assessment

Education

Chemical/Mechanical/Bio-Engineering

Tools

AutoCAD

MS Project

Smartsheet

CMMS (Blue Mountain RAM/Maximo/Fiix)

Job description

Strive Pharmacy in Alachua, FL is seeking a Validation Engineer III to manage end-to-end validation documentation within a GMP-regulated facility. You will bridge operations, validation execution, and project delivery, ensuring all lifecycle docs meet global standards.

The role requires 10+ years of engineering/validation experience, expertise in ASTM E2500, ISO cleanroom classifications, and proficiency with AutoCAD, MS Project/Smartsheet, and CMMS systems. On-site work Monday–Friday.