Validation Engineer

Responsibilities:

Review qualification requirements for any new instrument, equipment and process with system owner and cross-functional teams.

Prepare protocols and reports related to equipment/system/utility qualification (IQ/OQ/PQ), calibrations, engineering, process, packaging, and cleaning validations. Preparation and review of associated procedures, change controls, standard operating procedures, validation master plans, etc.

Execute protocols and related activities associated with validating equipment/ systems/ utilities/ processes, transferring new products/ processes from R&D to manufacturing, and executing process/documentation improvements. Perform statistical analysis for process monitoring.

Initiate and investigate protocol deviations, events, exceptions, and coordinate follow up with QA.

Initiate, follow-up, close out and implementation of corrective and preventive actions.

Co-ordinate activities related to risk management and preparation of quality risk management and risk assessments related to but not limited to instruments, equipment, products, and processes.

Coordinate with cross functional teams for internal and external audits. Provide all required documentation.

Perform other duties as assigned.

Requirements:

Bachelor's degree, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.

Analytical – Working knowledge of cGMPs and internal SOPs; identifies, collects, and organizes data from multiple sources; ability to handle several projects simultaneously; demonstrates attention to detail; identifies and resolves problems in a timely manner.

Technical Skills – Mechanically inclined; reads and interprets process documents and validation protocols; follows operating instructions; and good computer skills; ability to make timely decisions, Assist Manufacturing management/QA management in performing root cause analysis.

Ability to read, write and interpret documents such as Site Master Plans, Validation Master Plans, Validation protocols, Technology Transfer Documents, Master Production Records, Operating and Maintenance Instructions, and procedures manuals.

A background in cGMP compliance within the pharmaceutical, biologics, or medical device manufacturing industry