Responsibilities:  

This position is responsible for executing computerized system validation projects and supporting the validation lifecycle of existing and new computerized systems for pharma and biotech process equipment or QC lab equipment with associated computerized system. The candidate will be responsible for executing risk-based validation related to computer system validation in alignment with the GxP regulations such as 21 CFR Part 11, Annex 11, GAMP 5,etc.   

• Perform and review computerized system validation deliverables according to 21 CFR Part 11, Annex 11, GAMP 5 and other regulatory requirements
• Generate and/or review validation documentation - such as user requirements, functional requirements, configuration specification, Validation Master Plan (VMP), IQ/OQ/PQ documentation, GxP criticality assessments, Electronic Records Electronic Signature (ERES) assessments, Data Integrity (DI) assessments, test scripts, trace matrix requirements, deviations, validation summary reports, and system use documentation (system admin, user admin procedures).
• Author and develop SOPs for computer system validation for manufacturing and QC Lab equipment.
• Responsible for executing and reviewing control systems validation activities including projects associated with PCS, BMS, EMS, OSI PI, and other automation upgrades.
• Collaborate with equipment vendors for Windows upgrades and perform CSV activities necessary for the QC Lab equipment/system.
• Ensure that a consistent computerized system validation approach is utilized for IT infrastructure, Computerized Process Equipment, Manufacturing Computerized Systems, and QC Lab Systems.

Qualification and Requirements:  

• Bachelors or master’s in engineering, science, or equivalent technical degree.
• 3-5 years of experience in a regulated, manufacturing environment within the biotechnology or pharmaceutical industry.
• 3 years of project experience with Computer systems validation experience with or for manufacturing equipment and processes, as well as utilities, and facilities. Experience with Validation lifecycle documentation (URS, FS, DS, ERES Assessment, DI Assessment, IQ, OQ, etc.)
• Experience with Quality Systems (handling Change Controls, Non-Conformances, Deviations, CAPAs)
• Expertise in CSV for custom built and/or off the shelf equipment
• Experience in GAMP-5 category 3, 4, and 5 equipment computer system validation
• Good knowledge and skills in engineering of HVAC/Cleanrooms/Process Equipment and Utility/Building Management Systems
• GMP compliance knowledge including knowledge of 21 CFR Parts 11, 210, 211 requirements, Data Integrity, ICH Q7A requirements, and GAMP 5
• Excellent written and verbal communication skills; excellent technical writing skills.
• Strong interpersonal skills and the ability to work in a team environment.
• Ability to work effectively in a fast-paced multitasking environment.