Validation Technician

Ferndale Pharma Group•Ferndale, MI

About The Position

Responsible for preparing protocol and report documentation and executing equipment, system and utility installation, operation and process qualifications in accordance with cGMPs and approved SOPs. Assist Validation team members in maintaining the equipment requalification program and equipment calibration program. Assist Validation team members with process validations and continued process validations, as needed. Responsible for preparing and executing qualification documentation for a variety of quality control, utility, facility and process equipment. This includes IQs, OQs, PQs, and other validation documents. Assists in the execution of process validation and continued process validation protocols, as needed. Prepare final reports for any validation document including IQs, OQs, PQs, RQs and other validation documentation. Assists in maintaining the cleaning validation program. Maintains compliance of Manufacturing/Quality Control/Development equipment through the requalification program. Writes and reviews relevant Standard Operating Procedures (SOPs). Must be able to work independently and in a team environment. Coordinate the proper review and approval of validation documentation. Coordinate validation studies, evaluates and analyzes validation data related to projects and writes reports Supports and reviews equipment calibration, protocols, and data packages/documents of colleagues as needed. Write-up or assist in quality investigations pertaining to equipment, calibration and cleaning failures.

Requirements

Requires 3-5 years of experience in a pharmaceutical environment with relevant experience in Validation, QA, and Technical Writing preferred.
Knowledge of cGMP and FDA policies are required.
Excellent written and verbal communication skills as well computer skills including Microsoft Word, Excel and PowerPoint.
SOP writing skills are required along with the ability to handle multiple projects simultaneously.
Requires a Bachelor’s degree or an equivalent combination of education and relevant experience.
As Federal Contractors, onboarding includes background checks and a pre-placement 10-panel drug screen and physical.

Responsibilities

Preparing protocol and report documentation
Executing equipment, system and utility installation, operation and process qualifications in accordance with cGMPs and approved SOPs
Maintaining the equipment requalification program and equipment calibration program
Preparing and executing qualification documentation for a variety of quality control, utility, facility and process equipment
Assisting in the execution of process validation and continued process validation protocols
Preparing final reports for any validation document including IQs, OQs, PQs, RQs and other validation documentation
Maintaining the cleaning validation program
Maintaining compliance of Manufacturing/Quality Control/Development equipment through the requalification program
Writing and reviewing relevant Standard Operating Procedures (SOPs)
Coordinating the proper review and approval of validation documentation
Coordinating validation studies, evaluates and analyzes validation data related to projects and writes reports
Supporting and reviewing equipment calibration, protocols, and data packages/documents of colleagues
Writing-up or assisting in quality investigations pertaining to equipment, calibration and cleaning failures