Validation Engineer III
About The Position
The Validation Engineer III manages the end-to-end lifecycle of validation documentation within a GMP-regulated pharmaceutical facility and bridges operational needs, validation execution, and project delivery. The role ensures that projects, equipment, facilities, utilities, commissioning, qualifications, and lifecycle documentation are completed on time and in compliance with global regulatory standards. This position is based on-site in Alachua, Florida, Monday through Friday. It includes occasional travel, up to 5%, for Factory Acceptance Testing at vendor sites or external vendor audits. The role involves working in active construction zones and mechanical utility spaces and may require handling potent pharmaceutical compounds under strict safety controls. The position pays an annual salary of $105,000–$115,000. Strive Pharmacy describes its work as personalized compounding care and emphasizes collaboration, employee growth, and a human-centered approach to patient and provider partnerships.
Requirements
- Bachelor of Science degree in Chemical, Mechanical, Bio-Engineering, or a related engineering field.
- At least 10 years of engineering and validation experience in a GMP-regulated environment, such as biotechnology, pharmaceutical, or medical device.
- Strong mastery of ASTM E2500.
- In-depth expertise in aseptic areas, ISO 5–8 cleanroom classification, and automated control systems such as PLC/SCADA.
- Practical knowledge of ASME BPE standards for bioprocessing equipment.
- Proficiency authoring and executing engineering and validation lifecycle documentation, commissioning and qualification protocols (IQ/OQ/PQ), and final or summary reports.
- Experience with 21 CFR Part 11 compliance and data integrity requirements for computerized systems.
- Comprehensive knowledge of risk-based validation approaches, including FMEA, and lifecycle management.
- Comprehensive knowledge of ISPE Baseline Guide Commissioning and Qualification methodology, including science- and risk-based approaches to system lifecycle management.
- Proficiency with AutoCAD, MS Project or Smartsheet, and CMMS platforms such as Blue Mountain RAM, Maximo, or Fiix.
- Ability to meet medical clearance and respirator fit-testing requirements before handling active pharmaceutical ingredients.
- Willingness to comply with ongoing medical monitoring, including baseline and periodic hormone level testing.
- Ability to work in active construction zones and mechanical utility spaces.
- Ability to work on-site Monday through Friday.
Responsibilities
- Develop and review technical and Engineering Turnover packages, including P&IDs, Process Flow Diagrams, and mass and energy balances.
- Author User Requirement Specifications and Functional Design Specifications for new process equipment and automation systems.
- Oversee integration of new equipment with existing facility utility infrastructure, including HVAC, electrical, clean utilities, and non-clean utilities.
- Ensure site project activities align with the Validation Master Plan and site Quality Management Systems.
- Initiate validation Change Controls and ensure modifications are risk-assessed and approved by QA before implementation.
- Perform Root Cause Analysis and lead investigations for project and validation deviations.
- Evaluate 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 address vendor documentation gaps.
- Manage Commissioning and Qualification through final handover to Operations.
- Coordinate with Metrology to onboard new instrumentation into the CMMS.
- Comply with Occupational Exposure Limits and NIOSH hazardous drug protocols when weighing, compounding, or packaging Schedule III hormones and other potent endocrine-disrupting compounds.
- Wear required specialized PPE, including respirators and full-body protective suits, and comply with medical clearance, fit-testing, and ongoing medical monitoring requirements.
- Travel occasionally, up to 5%, for vendor-site Factory Acceptance Testing or external vendor audits.
Benefits
- Employer-paid healthcare coverage, effective the first day of the month following the hire date.
- Free Strive compounded medications for employees with a valid patient-specific prescription from a licensed healthcare provider.
- Paid time off.
- Sick time.
- Flexible Spending Account (FSA) and Health Savings Account (HSA) options.
- Parental leave.
- 401(k) with employer matching.
- Life insurance.
- Vision insurance.
- Dental insurance.
- Veterinary insurance.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
