CSV Engineer

at  Katalyst Healthcares Life Sciences

Responsibilities:

• Project management, including timeline and resources, coordination with QA management regarding priorities and organization of departmental resources to support CSV activities (i.e., validation resources, as well as IT and business process owners). Work with Manufacturing (MFG), Facilities (FAC), Quality Control (QC), Quality Assurance (QA) and Information Technology (IT) to schedule CSV activities.
• Generate, revise, and execute CSV documentation for analytical instruments, process equipment, and facility computer systems and software ensuring compliance with 21 CFR Part 11, ICH Q7 Sections 12 and 13, GAMP and other regulatory and industry standard requirements as deemed necessary.
• Partner with Quality Systems and IT to ensure policies and procedures reflect up-todate regulatory expectations for CSV.
• Generate, revise and/or review plans, policies, procedures, reports, specification documentation and vendor qualification documents related to CSV; including but not limited to; protocols (IQ/OQ/PQ), URS’s, FRS’s, test plans, trace matrices, technical reports, and CSV summary reports using Good Documentation Practices (GDPs).
• Investigate and resolve exceptions, nonconformances, deviations and resolutions, CAPA’s, and change controls related to CSV protocols.
• Demonstrates behavior consistent with the Integrated DNA Technologies Core Values.
• Performs other duties as assigned.

Requirements:

• B.S. degree in engineering, biology, chemistry, computer science, mathematics, or similar discipline
• 2-4 years of experience in Validation or Quality Departments
• Knowledge of the regulatory and cGMP regulations for pharmaceutical manufacturing operations, and validation procedures and practices, including 21 CFR Part 11, Annes 11, industry guidance, such as GAMP 5, experience with a variety of software applications and operating systems.
• Strong verbal, written, analytical, and persuasive skills and the ability to interact effectively with all levels of employees and management.
• Ability to work well with diverse, multi-disciplined groups and effectively communicate with management and fellow project team members.
• Attention to detail - it is vital that validation engineers follow validation protocols precisely to ensure that the results are reliable, demonstrated understanding of cGMPs, ability to apply cGMPs and recognize variances from cGMPs.
• Suitable experience and knowledge in the area of computer system validation (CSV), remediation and implementation, in lieu of degree, will be considered.
• Experience with qualifying systems such as LIMS, ERP, CMMS, Client, analytical systems, and processes, and experience drafting Validation Master Plans and Validation Project Plans.
• Ability to work independently with initiative, good planning and organizational skills, flexibility for changes in work priorities and amount of activities.

• Project management, including timeline and resources, coordination with QA management regarding priorities and organization of departmental resources to support CSV activities (i.e., validation resources, as well as IT and business process owners). Work with Manufacturing (MFG), Facilities (FAC), Quality Control (QC), Quality Assurance (QA) and Information Technology (IT) to schedule CSV activities.
• Generate, revise, and execute CSV documentation for analytical instruments, process equipment, and facility computer systems and software ensuring compliance with 21 CFR Part 11, ICH Q7 Sections 12 and 13, GAMP and other regulatory and industry standard requirements as deemed necessary.
• Partner with Quality Systems and IT to ensure policies and procedures reflect up-todate regulatory expectations for CSV.
• Generate, revise and/or review plans, policies, procedures, reports, specification documentation and vendor qualification documents related to CSV; including but not limited to; protocols (IQ/OQ/PQ), URS’s, FRS’s, test plans, trace matrices, technical reports, and CSV summary reports using Good Documentation Practices (GDPs).
• Investigate and resolve exceptions, nonconformances, deviations and resolutions, CAPA’s, and change controls related to CSV protocols.
• Demonstrates behavior consistent with the Integrated DNA Technologies Core Values.
• Performs other duties as assigned