Validation Engineer III

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 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) 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).
• 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).

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 endocrine-disrupting compounds.
• Required to wear specialized PPE, including respirators and full-body protective suits, for extended periods. Candidates must be medically cleared to wear a respirator and pass standard fit-testing prior to handling active pharmaceutical ingredients.
• Willingness to comply with ongoing medical monitoring, including baseline and periodic hormone level testing as part of our commitment to employee health and workplace safety.
• Ability to work in active construction zones and mechanical utility spaces.
• Occasional travel (up to 5%) for Factory Acceptance Testing (FAT) at vendor sites or external vendor audits.
• Ability to work in active construction zones and mechanical utility spaces.

$105,000 - $115,000 USD

Strive Pharmacy offers a comprehensive benefits package, including:

• Employer-paid healthcare coverage, effective the 1st day of the following month of your hire date
• Free Strive compounded medications for employees based on a valid patient-specific prescription from a licensed healthcare provider
• Paid time off
• Sick time
• FSA and HSA options
• Parental leave
• 401(k) with employer matching
• Life insurance
• Vision and dental insurance
• Veterinary insurance

Join Us in Making an Impact:

At Strive, the work is real and the impact is direct. Every role here contributes to a patient experience that's more personal, more attentive, and more human than what most people have come to expect from a pharmacy.

Culture:

Culture isn't an afterthought at Strive. It's something we actively build. We foster a collaborative, engaging workplace where employees have opportunities to connect, celebrate, and build meaningful relationships with their colleagues. We're committed to supporting the personal and professional growth of every employee, both inside and outside the workplace.

EEO:

Strive Pharmacy is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristics as outlined by federal, state or local laws.

Disclaimer*** Please do not call the pharmacy location with questions about your application or interview. A talent acquisition partner will reach out to you.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Strive Pharmacy’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.