Senior Validation Engineer – GMP & CQV (Pharma)

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

Benefits offered by this job

Employer-paid healthcare coverage

Free Strive compounded medications

Paid time off

Sick time

401(k) with employer matching

Life insurance

Vision and dental insurance

Parental leave

FSA and HSA options

Job summary

Strive Pharmacy is seeking a Validation Engineer III to manage end-to-end validation documentation in a GMP-regulated facility. You will bridge operations, validation execution, and project delivery, ensuring timely qualification of equipment, facilities, and utilities in line with global regulatory standards.

The role requires 10+ years of engineering/validation experience in biotech/pharma, expertise in ASTM E2500, 21 CFR Part 11, and CQV methodologies, and on-site work in Alachua, FL.

Qualifications

• B.S. in Chemical, Mechanical, Bio-Engineering, or related field.
• 10+ years of engineering and validation in GMP environment (Biotech, Pharma, Med Device).
• Experience with cGMP documentation and validation lifecycle.

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.
• Oversee integration of new equipment into facility utilities (HVAC, Electrical, clean/non-clean).
• Ensure activities align with VMP and QMS.
• Initiate validation Change Controls and QA-approved modifications.
• Perform RCA and lead investigations for deviations.
• Evaluate vendor validation/engineering packages and close gaps.
• Coordinate C&Q through handover to Operations with CMMS onboarding.

Skills

ASTM E2500

Aseptic areas

ISO cleanrooms

PLC/SCADA

21 CFR Part 11

Risk-based validation

CQV methodology

AutoCAD

MS Project/Smartsheet

CMMS platforms

Education

B.S. in Chemical/Mechanical/Bio-Engineering or related field

Tools

AutoCAD

MS Project / Smartsheet

CMMS platforms (Blue Mountain RAM, Maximo, Fiix)

Job description

Strive Pharmacy is seeking a Validation Engineer III to manage end-to-end validation documentation in a GMP-regulated facility. You will bridge operations, validation execution, and project delivery, ensuring timely qualification of equipment, facilities, and utilities in line with global regulatory standards.

The role requires 10+ years of engineering/validation experience in biotech/pharma, expertise in ASTM E2500, 21 CFR Part 11, and CQV methodologies, and on-site work in Alachua, FL.