AT01-040325 Validation Specialist - NC

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.