What are the responsibilities and job description for the AT01-040325 Validation Specialist - NC position at Validation & Engineering Group?
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.
