Computer System Validation Engineer III

Canton, MA

Job Req code: 801

Category: Quality Systems

Organogenesis corporate headquarters is located in Canton, Massachusetts, including manufacturing, R&D, customer service, reimbursement and other corporate teams supporting our full range of products. We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing.

The Computer System Validation Engineer will be designated to support validations for two Organogenesis CGMP facilities. The engineer will be responsible for researching, developing, and executing Installation, Operational, Performance Qualification, Requalification and Revalidation protocols for stand-alone Computer Systems (local server(s) and cloud based) and embedded computer systems in manufacturing equipment (as applicable). The Engineer will write and execute protocols and maintain records for validations.

Job Responsibilities:

• Prepares protocols and reports for initial validation, requalification, and revalidation work

• Assists in the development of URS and FRS documents to identify computer system requirements with end users (as applicable).

• Performs testing using standard computer qualification concepts, practices and procedures of the CGMP process and is consistent with established OI testing methodologies.

• Responsible for the generation and maintenance of traceability matrices.

• Reviews and assesses vendor supplied computer system validation documentation for alignment with OI requirements. Generates OI gap protocols where deficiencies are identified.

• Reviews and summarizes the output of completed executed computer system scripts for vendor supplied documentation.

• Participate in the creation and/or review of Standard Operating Procedures (SOPs) for computer system projects

Requirements

Job Requirements:

The candidate must have previous computer system validation experience in Pharmaceutical/Medical Device/Biologics industry, be familiar with GAMP Computer System Principles, be able to work independently, possess strong organizational skills, and have good written and verbal communication skills.

Minimum Associates/Bachelor’s degree with 3-5 years of experience validating GXP computer systems.  Candidate will be a highly motivated and creative individual with strong hands-on validation skills working under minimal supervision. Strong technical writing skills are essential. A high level of competency with qualification of the following types of computer system qualifications: ERP systems