Validation is a regulatory requirement and must be conducted in conformance to cGMPs and FDA requirements. The Validation Technician or Specialist I will be part of a cross functional team that will execute validation studies for process, cleaning, computerized systems, and qualification of equipment and critical utilities needed to support clinical and commercial distribution of sterile and non-sterile pharmaceutical products.
The Validation Technician or Specialist I provides hands-on support for validation and qualification activities within a pharmaceutical manufacturing environment. This entry-level role assists with the execution, documentation, and maintenance of validation programs for equipment, utilities, facilities, computerized systems, and manufacturing processes. The position plays a critical role in ensuring compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and company quality standards.
This role is ideal for individuals beginning a career in pharmaceutical manufacturing, quality, engineering, or validation.
Duties & Responsibilities
- Learn to execute validation protocols under the guidance of Validation Engineers and Quality personnel
- Perform data collection and testing activities during, Installation Qualification, Operational Qualification and Performance Qualification
- Assist with equipment startup, commissioning, and qualification activities
- Record validation results accurately and in accordance with Good Documentation Practices (GDP)
- Collect and organize calibration, maintenance, and testing records required for validation packages
- Review completed validation documentation for accuracy and completeness
- Support environmental, utility, and process monitoring activities as required
- Assist in identifying and documenting validation deviations and discrepancies
- Maintain validation logs, binders, and electronic records
- Work closely with Manufacturing, Engineering, Maintenance, Laboratory, and Quality teams to coordinate validation activities
- Ensure all activities comply with safety procedures, cGMP requirements, and company policies
- Support regulatory inspections and internal audits by retrieving and organizing validation documentation
Required Skills & Abilities
Technical Skills
- Ability to follow detailed procedures and work instructions
- Basic understanding of mechanical and process equipment
- Proficiency with Microsoft Word, Excel, and Outlook with the ability to learn QMS systems
- Ability to accurately document test results and observations
- Basic troubleshooting and problem-solving skills
Preferred Knowledge
- Good Manufacturing Practices (cGMP)
- Good Documentation Practices (GDP)
- Pharmaceutical or biotechnology manufacturing operations
- Equipment calibration and maintenance concepts
- Validation and qualification processes
Education & Experience
- High School Diploma required, technical certification or degree prefered
- Minimum of 2 years of experience in a manufacturing, quality, engineering, or validation role
- Internship, co-op, vocational training, or GMP experience preferred
Physical Requirements
- Prolonged periods of sitting or standing at a desk and working on a computer
- Prolonged periods of sitting or standing in a manufacturing environment
- Must be able to lift 25 pounds at times
- Adheres to consistent and predictable in-person attendance
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