CSV Engineer lV

PCI Pharma Services•Bedford, NH

About The Position

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The CSV Validation Engineer IV is responsible for authoring and reviewing validation deliverables within the Computer System Lifecycle (e.g. Validation Plans, SOPs, Protocols, Trace Matrix, Assessments, and Reports). Participate in developing and revising validation procedures and protocols to meet regulatory requirements and site quality and validation procedures. corporate & site quality management system and current industry practices. Interact with CSV Management to prioritize and/or harmonize activities. Participate in multi-site CSV initiatives through document development or other validation activities. The CSV Validation Engineer IV is responsible for authoring, reviewing and approving system assessments, test documents, change controls, process improvements and compliance governance at all applicable points of the system life cycle for all PCI sites. In addition, this individual will serve as the SME to provide compliance leadership and oversight for CSV projects. Collaborate with departments -within the organization to maintain and improve computerized system validation processes to ensure robust, efficient, and compliant processes.

Requirements

Ten plus (10+) years of relevant computer systems validation, project management or operations experience within a cGMP environment, with at least 5 years of recent validation/engineering experience.
Computer systems validation experience for GMP manufacturing, laboratory, quality, as well as utilities, and facilities.
Experience in the biotechnology and/medical or pharmaceutical industry.
Proficiency of Computers Systems Validation and Quality Systems.
Good understanding of software supporting automated systems, laboratory equipment, and quality systems.
Knowledge regulatory guidelines including 21 CFR Parts 11, 210, 211, and 820 requirements, Data Integrity, ICH Q7A requirements, and GAMP
Experience in thorough testing of applications, computerized systems, changes and implementations.
Excellent written and oral communication to include accurate and legible documentation skills.
Ability to work in a fast-paced environment.
Team oriented.
Independent work skills and a strong work ethic.
Microsoft Office and database management skills.
Ability to handle multiple projects

Responsibilities

Generate, review and approve local validation and compliance documents supporting GxP computerized and computer systems, and relevant infrastructure.
Provide support for SOPs, qualification protocols, gap assessments, risk assessment, Impact Assessment, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change controls.
Execute validation protocols; assists in deviations and corrective actions plans; and write reports, trace matrices; and assists in system SOP updates to ensure system is complaint and operates per intended use.
Perform Gap Assessments and Remediation Plans with an understanding of applying risk management principles.
Ensure appropriate regulations, such as 21 CFR Part 11, 820 and cGMP regulations, are addressed in validation.
Performs periodic reviews and ongoing support of validated systems post Go-Live.
Perform revalidation and change control validation related activities.
Ability to apply complex system validation principles to work assignments.
Responsible for executing and reviewing control systems validation activities, and other system/equipment upgrades.
Assess the impact of system changes thru change management and change control systems; participate in the planning and implementation of change.
Provide training to colleagues and contractors on our approach to systems implementation and validation SOP's.
Assist validation activities of cross functional teams that include technical functions such as Information Systems, Manufacturing, Quality Control, and Engineering.
Develop and maintain Validation SOPs, and forms.