Validation Specialist

2 days ago

Archer Lodge, NC, United States Validation & Engineering Group Inc. Full time
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Device industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to working under the highest ethical standards for the following position:
  • Validation Specialist - North Carolina
Essential Responsibilities:
  • Ownership of change requests related to project validation responsibilities.
  • Assist with the development and improvement of system user requirements.
  • Author implementation plans, validation plans, and other key validation documentation.
  • Author and execute assigned IV, OV, and PV protocols for direct impact systems/processes per approved timelines.
  • Provide validation and technical support through preparation, execution, data analysis, and report writing for IV, OV, and PV protocols.
  • Perform compliance and technical reviews/approvals of protocols and protocol data.
  • Complete responsibilities with limited guidance and direction; no coaching required on technical competencies.
  • Ensure executed validation protocols are compliant with local, corporate, and regulatory requirements.
  • Lead validation failure investigations and non-conformities using root cause analysis techniques.
  • Participate in FAT and SAT commissioning for computerized equipment, automation systems, and processes, and successfully transition into the validation ownership role.
  • Identify process improvements before equipment, systems, or processes are placed under change control.
  • Coordinate and communicate with IT and Automation teams to ensure validation goals are met.
  • Lead validation activities as assigned by the overall project manager.
  • Create and modify validation procedures and configuration item lists as needed.
  • Seek new and innovative solutions.
  • Experience with IT systems such as PAS-X, SAP, and Aveva PI.
  • Experience with computerized equipment such as autoclaves, packaging, assembly, filling, cart washers, utensil washers, CIP/SIP, formulation, etc.
Physical Requirements:
  • On-site work includes time on an active construction site.
  • Move equipment and/or supplies weighing up to 33 pounds within the facility.
  • Perform close precision work with hands.
  • Remain stationary (sitting or standing) for approximately 50% of the time.
  • Occasionally ascend/descend ladders.
  • May be required to work at elevated heights.
  • Occasionally work around odors and/or hazardous materials.
Qualifications:
  • BA/BS in Engineering, Computer Science, or a relevant technical discipline, or proven equivalent work experience.
  • Minimum of 5 years of experience in validation or quality-related disciplines within the pharmaceutical industry.
  • Familiarity with regulatory requirements and industry standards (e.g., cGMP, 21 CFR Part 11, GAMP 5, ISO, electronic records retention, configuration item lists, FDA and ICH guidance documents).
  • Demonstrated experience applying root cause analysis to problem-solving.
  • Ability to read, write, and understand complex product documentation.
  • Strong leadership and project management skills, including effective two-way communication, teamwork, and the ability to meet timelines and customer expectations.
  • Ability to write technical documentation based on equipment manuals.
  • Strong task and time management skills, with the ability to prioritize effectively.
  • Agile and adaptable in dynamic environments.
  • Accountable and reliable.
  • Committed to simplicity and reducing unnecessary complexity.

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