Overview
Validation Specialist Jobs in Pennsylvania, United States at Invent Staffing
Title: Validation Specialist
Company: Invent Staffing
Location: Pennsylvania, United States
Key Responsibilities
Develop and lead execution of commissioning, qualification, and validation (CQV) plans and protocols (IQ/OQ/PQ).
Review and provide feedback on design documentation to ensure fit-for-purpose solutions.
Perform Factory Acceptance Testing (FAT) and support Site Acceptance Testing (SAT).
Create and maintain accurate documentation including protocols, reports, and deviation records.
Collaborate closely with internal Capital Engineers (Process Engineers), TCS (system integrator), and OEMs to implement robust solutions.
Support compliance efforts to meet FDA, cGMP, and internal quality standards.
Build out project timelines and execution strategies in collaboration with SMEs and cross-functional teams.
Required Skills & Qualifications
Minimum 5 years of engineering experience in Pharmaceutical, Food, or Aerospace Manufacturing.
Proven track record in executing Commissioning and Qualification plans for large-scale capital projects.
Hands-on experience with IQ/OQ/PQ protocol development and execution.
Experience working with automated systems, robotics, or digital transformation initiatives in a manufacturing setting.
Strong communication and documentation skills; able to coordinate with internal and external stakeholders effectively.
Preferred Qualifications
Background in Pharmaceutical Manufacturing, particularly with Aseptic Filling Lines or Bioreactor Systems.
Experience in FDA-regulated environments with a strong understanding of cGMP.
