Validation Engineer III

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 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. Annual Salary $105,000—$115,000 USD **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. Apply today and help us raise the bar. **Benefits/ Perks:** 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 **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.**