Validation Technician at Leiters Inc

Inverness, Colorado, United States -

Full Time

Start Date

Immediate

Expiry Date

02 Jan, 26

Salary

0.0

Posted On

04 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Validation, Qualification, Documentation, Compliance, Quality Assurance, Engineering, Operations, Analytical Skills, Organizational Skills, Pharmaceutical Regulation, cGMP, Aseptic Techniques, Validation Protocols, Cleaning Validation, Sterilization Validation, Cleanroom Environment

Industry

Pharmaceutical Manufacturing

Description

Job Description: Validation Technician Position Summary The Validation Technician supports the qualification and validation activities required to maintain compliance within a 503B outsourcing facility. This role is responsible for executing validation protocols, performing routine equipment and facility qualification/requalification, and documenting results in accordance with regulatory standards. The Validation Technician will work closely with Quality, Engineering, and Operations teams to ensure processes, equipment, and systems are compliant, reliable, and inspection-ready. Key Responsibilities Validation & Qualification * Execute validation and qualification protocols for equipment, utilities, facilities, and processes (IQ/OQ/PQ). * Perform routine requalification activities to ensure continued compliance with regulatory standards. * Support routine re-qualification activities. * Assist with data collection, sampling, and analysis for validation studies. Documentation & Compliance * Accurately complete validation records, test logs, and reports in alignment with cGMP requirements. * Ensure all protocols, discrepancies, and final reports are documented, reviewed, and archived per SOPs. * Participate in investigations, CAPAs, and audits as needed. Cross-Functional Support * Collaborate with Quality Assurance, Engineering, and Operations to support validation schedules and project timelines. * Assist in the evaluation of new equipment and processes for validation requirements. * Support the implementation of best practices, new technologies, and process improvements. Qualifications * Associate or Bachelor’s degree in Engineering, Life Sciences, or related technical field preferred; equivalent relevant experience considered. * 2+ years of validation, quality, or technical experience in pharmaceutical, biotech, or compounding operations (503B experience strongly preferred). * Working knowledge of Pharmaceutical regulation, cGMP, and aseptic techniques. * Familiarity with validation protocols (IQ/OQ/PQ), cleaning validation, and sterilization validation. * Strong documentation, analytical, and organizational skills. * Ability to work in a cleanroom environment and adhere to gowning/aseptic practices.

Responsibilities

The Validation Technician executes validation protocols and performs routine equipment and facility qualification activities. They document results in accordance with regulatory standards and collaborate with cross-functional teams to ensure compliance and reliability.