Validation Engineer III

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

Job summary

Strive Pharmacy in Alachua, FL is seeking a Validation Engineer III to manage end-to-end validation documentation in a GMP facility, bridging operations, validation, and project delivery.

The role requires strong technical validation expertise, experience with commissioning/qualification, and compliance with global regulatory standards; on-site Monday to Friday is expected in a clean GMP environment.

Qualifications

• BS in Chemical, Mechanical, or Bio-engineering.
• 10+ years in engineering/validation within GMP settings.
• Experience with CQV lifecycle and 21 CFR Part 11.

Responsibilities

• Engineering commissioning: develop and review P&IDs, PFDs, and mass/energy balances.
• GMP compliance & validation: own Validation Master Plan and QA-led changes.
• Documentation execution: write IQ/OQ/PQ protocols and risk assessments.
• Vendor/documentation: assess vendor validation packages and gap analyses.
• Turn-key handover: coordinate with Metrology for CMMS onboarding.

Job description

Company Overview:

Strive Pharmacy is a personalized compounding pharmacy built on a simple conviction: medicine should fit the patient, not the other way around. We started Strive because we believed the pharmaceutical industry was overdue for a more human approach-one that prioritizes individualized care, clinical nuance, and genuine partnership with patients and providers.

Compounding gives us the tools to do that. Every formulation we prepare is built to the specific needs of a specific person, and every interaction we have is guided by that same commitment to personalized care.

We're growing, and we're looking for people who share that conviction. If you're ready to be part of a pharmacy that takes the work seriously and the people even more seriously, we'd like to meet you.

Mission:

Strive exists to disrupt an industry long overdue for a more personal approach to care. We put the human element at the center of everything: every formulation, every patient interaction, every provider partnership. We're not just a compounding pharmacy. We're a team on a mission to change what personalized healthcare looks and feels like.

Position Summary:

The Validation Engineer III is responsible for managing the end-to-end lifecycle of the validation documentation within a GMP-regulated pharmaceutical facility. This role serves as the bridge between operational needs, validation execution, and any project delivery.

The successful candidate brings a strong balance of technical validation expertise, to ensure projects and equipment, facilities and utilities commissioning, qualifications and all lifecycle documentation are completed on time and in full compliance with global regulatory standards.

Location: Alachua, FL (on-site Monday - Friday)

Salary: $105,000 - $115,000

Position Type: Full-Time

Key Responsibilities:

Engineering Commissioning

• Develop and review technical packages, Engineering Turnover packages, including P&IDs, Process Flow Diagrams (PFDs), and mass/energy balances.
• Author User Requirement Specifications (URS) and Functional Design Specifications (FDS) for new process equipment and automation systems.
• Oversee the integration of new equipment into existing facility utility infrastructure (HVAC, Electrical, Clean & Non Clean Utilities).

GMP Compliance, Validation & Commissioning

• Validation Ownership: Ensure all site project activities align strictly with the Validation Master Plan (VMP) and site Quality Management Systems (QMS).
• Change Control & Investigations: Initiation of validation Change Controls, ensuring modifications are risk-assessed and approved by QA before implementation. Perform Root Cause Analysis (RCA) and lead investigations for project/validation deviations.
• Engineering/Validation Execution: Evaluation of vendor-supplied validation and engineering documentation packages.Perform documentation gap analyses against cGMP, engineering, and regulatory standards. Author supplemental validation protocols, risk assessments, and mitigation plans to close identified vendor documentation gaps.
• Procurement & Turn-key Handover: Manage Commissioning & Qualification (C&Q) through final handover to Operations, coordinating with Metrology to onboard new instrumentation into the CMMS.

Qualifications & Skills:

• Education: B.S. in Chemical, Mechanical, Bio-Engineering, or related engineering field.
• Experience: 10+ years of engineering and validation experience in a GMP-regulated environment (Biotech, Pharma, or Med Device)..

Technical Knowledge:

• Strong mastery of ASTM E2500 (Standard Guide for Specification, Design, and Verification of Pharmaceutical Manufacturing Systems).
• In-depth expertise in aseptic areas, cleanroom classification (ISO 5-8), and automated control systems (PLC/SCADA).
• Practical knowledge of ASME BPE standards for bioprocessing equipment.
• Proficiency in authoring and executing engineering and validation lifecycle documentation, commissioning and qualification protocols (IQ/OQ/PQ) and final/ summary reports.
• Experience with 21 CFR Part 11 compliance and data integrity requirements for computerized systems.
• Comprehensive knowledge of risk-based validation approaches (FMEA) and lifecycle management.
• Comprehensive knowledge of ISPE Baseline Guide: Commissioning and Qualification (CQV) methodology, including science and risk-based approaches to system lifecycle management.

Software:

• Proficiency in AutoCAD, MS Project / Smartsheet, and CMMS platforms (e.g., Blue Mountain RAM, Maximo, or Fiix).

Work Environment:

This position is primarily based in an onsite work environment. The role requires regular periods of sitting, standing, and computer use, with occasional lifting as needed. Reasonable accommodations may be made for individuals with disabilities. This role also requires the following: Must adhere to strict Occupational Exposure Limits (OELs) and NIOSH hazardous drug protocols when weighing, compounding, or packaging Schedule III hormones and other potent endo