Manager, Computer System Validation (CSV) - Summit West NJ

Military Spouse Corporate Career Network•Summit West, NJ

2d•Onsite

About The Position

The Manager, CSV Cell Therapy supports implementation and ongoing support of manufacturing and laboratory equipment and computerized systems at multi-use sites, working with internal customers and external service providers. With general instructions and minimal supervision, the role performs routine tasks, uses analytical skills to resolve problems, and collaborates with colleagues and stakeholders across the organization. Through hands-on leadership, the manager is responsible for individual and team efforts and projects, fosters a productive learning environment, and ensures assigned work is completed on time. The position maintains qualified and validated equipment and systems in compliance with applicable policies, guidelines, and procedures. It owns qualification lifecycle deliverables and full computer system validation activities for single- and multi-user systems, supports equipment implementation projects, and develops validation documentation. The manager also leads projects, directs team members and vendors, provides customer and technical support, authors procedures and training materials, and serves as a departmental subject matter expert during internal and regulatory audits. The role is primarily based in an office environment, with required access to laboratory or GMP process areas while wearing appropriate gowning and personal protective equipment. The position is listed as on-site unless otherwise specified. Compensation is listed as $106,630–$129,214 for Summit West, New Jersey, and $134,390–$162,843 for field positions in the United States.

Requirements

Bachelor of Science degree or equivalent experience.
At least 5 years of experience in an FDA-regulated industry.
Excellent understanding of cGXP requirements and good documentation practices for systems, equipment, and instrumentation in the pharmaceutical industry.
Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance.
Strong working knowledge of SDLC principles and standards.
Ability to work with end users to identify and document user and functional requirements.
Knowledge of pharmaceutical laboratory and manufacturing systems.
Experience executing equipment qualification documents.
Ability to interact effectively with manufacturing, laboratory, QA, and Facilities groups.
Strong working knowledge of Microsoft Windows client and server technologies.
Ability to organize work in a fast-paced environment, monitor concurrent tasks and assignments, and manage multiple activities simultaneously.
Strong written, verbal, and presentation skills, including the ability to write clear emails and reports.
Ability to follow oral and written instructions and read and interpret relevant engineering manuals and drawings.
Ability to communicate effectively with employees, contractors, and vendors.
Experience with technical writing and document development or generation.
Strong computer skills in Microsoft Office, including Word, Excel, Visio, and Outlook, and ability to learn new software as needed.
Occasional physical activity including stooping, bending, stretching, pushing, pulling, reaching, and lifting up to 25 pounds; ability to sit, stand, walk, and move within the workspace for extended periods; and ability to perform repetitive hand and finger tasks.
Ability to work safely and effectively alone or with others.

Responsibilities

Maintain qualified and validated equipment and systems in compliance with applicable policies, guidelines, and procedures.
Support equipment qualification and validation activities, including execution of qualification and validation protocols.
Investigate and resolve deviations, CAPA investigations, and other potential issues.
Configure computerized systems and document configurations to meet 21 CFR Part 11 requirements.
Supervise vendors performing qualification functions.
Complete qualification and validation documentation accurately and in compliance with company standards.
Own lifecycle deliverables for equipment qualification and full CSV of single- and multi-user computerized systems.
Develop validation and qualification deliverables, including validation plans, requirements specifications, validation protocols, traceability matrices, summary reports, and change controls.
Initiate, manage, and lead projects of moderate scope and complexity; manage projects of varying scope and complexity.
Supervise and direct team members to ensure objectives are completed.
Maintain positive relationships with team members and site customers and promote a positive learning and team environment.
Author quality procedures and training documents, and deliver training on procedures and best practices to personnel and business partners.
Research and develop tools and solutions to improve departmental efficiency and compliance.
Support laboratory and manufacturing equipment implementation projects, including scheduling, procurement, site preparation, installation, qualification, and turnover to the business area.
Support standardization efforts by reviewing and approving validation deliverables.
Provide customer service and support; review, prioritize, and respond promptly to customer equipment qualification and support requests.
Provide technical guidance on validation, quality processes, and equipment qualification, and interface with customers to ensure expectations are met.
Ensure equipment, facilities, and programs are maintained in compliance.
Act as departmental lead and subject matter expert during internal and regulatory audits.