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.