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
Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Benefits Summary:
Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.