Senior Validation Engineer

August Bioservices•Nashville, TN

2d•Onsite

About The Position

The Sr. Validation Engineer will be responsible for leading validation related tasks for the Nashville site. The Senior Validation Engineer independently directs and performs validation tasks to serve customer needs and maintain compliance with cGMPs. Manages validation projects, develops Validation Master Plans, Protocols and Final Reports. Represents Validation Department on interdisciplinary facility teams.

Requirements

Seven (7) years of experience in pharmaceutical validation and qualifications
Seven (7) years of experience in aseptic sterile injectable pharmaceutical manufacturing involving validation, qualification, and lifecycle management of equipment, utilities, and processes in cGMP-regulated environments
Hands-on expertise in commissioning, qualification, and validation (IQ/OQ/PQ) of process equipment used for sterile injectable manufacturing process
Experience with Isolators, VPHP decontamination systems, autoclaves, depyrogenation tunnels, and sterile filling lines
Proven experience in VPHP cycle development, dwell time optimization, and BI challenge mapping for isolator decontamination systems
Knowledge of FDA 21 CFR Parts 210/211, EU Annex 1 (2023), ISPE Baseline Guide Vol 5 (2023 C&Q), and ICH Q9/Q10 principles
Experience in process validation (PPQ, CPV) and cleaning validation for sterile injectable facilities
Proficiency in developing and authoring Validation Master Plans, Risk Assessments (FMEA, SIA, FRA), and Discrepancy Reports/CAPAs
Demonstrated capability to lead cross-functional validation projects and support regulatory inspections (FDA, EMA) as site subject-matter expert (SME)
Experience with Validation Data Management (Kaye Validator) E QMS systems (Master Control, Blue Mountain, or equivalent)

Responsibilities

Independently prepares validation protocols (IQ/OQ/PQ) and final reports, Validation Master Plans, and Master Plan Summary Reports for equipment and processes
Oversees validation and revalidation studies for protocol compliance
Develops validation acceptance criteria
Performs validation fieldwork on an as-needed basis
Writes and revises Standard Operating Procedures (SOPs)
Recommends validation procedural and test improvements
Plan, track, and perform validation projects
Maintain current validation project schedules
Provide training for contract validation personnel
Review critical equipment drawings from a Validation perspective
Review and summarize equipment history files to assess the validated state of equipment
Manages validation projects, to include drawing on necessary resources to successfully complete validation projects within established timelines
Provide validation training/education on an as needed basis to project team members
Proactively identifies potential obstacles to successful project completion. Establishes remediation plans to overcome these obstacles
Participates as validation representative on failure investigation teams
Provide Validation Subject Matter Expertise for the organization