Job Summary

Responsible for computerized system validation activities within CRL Manufacturing Operations, including, but not limited to, equipment and software and for assisting in the selection and defining specifications such equipment and software. Responsible for maintaining all documentation pertaining to validation activities. Serve as an information resource for validation team members, contractors, and vendors.

ESSENTIAL DUTIES AND RESPONSIBILITIES:  
⦁    Manage the full lifecycle of validation projects including but not limited to delivering on time and to specification ensuring the delivery of a quality validation project at all times.
⦁    Write and assist in writing all validation deliverables within the Computer System Lifecycle, e.g. Validation Plans, Summary Reports, Configuration Specifications
⦁    Responsible for developing and revising test validation procedures/protocols in accordance with appropriate regulatory agency validation requirements, corporate & site quality management system and current industry practices.
⦁    Ensure the Systems Inventory is up to date at all times.
⦁    Maintain validation documentation and files including the Master Validation Plan (MVP) in defined locations per approved procedures.
⦁    Archive all validation documentation per approved procedures.
⦁    Write or assist in the writing of SOPs for the Validation Department.  
⦁    In collaboration with the technical/lab operations department plan installation, regular maintenance and repair of computerized systems and ensuring appropriate documentation.
⦁    Coordinate project meetings, steering committees, workshops and production of related documentation i.e. minutes of meetings, project plans etc.
⦁    Train and coach staff in relation to validation projects as required.
⦁    Manage cross functional teams involved in the validation project deliverables (e.g. Project Team, IT, Departmental Managers, vendors, etc). 
⦁    Provide project updates and input into established project documentation. 
⦁    Effectively communicate project expectations to team members and stakeholders in a timely and clear manner.
⦁    Assist other departments in response to their validation requirements as required.
⦁    Report any non- compliances of Quality Management System with respect to validation to the Senior Management.
⦁    Identify plan and schedule project timelines and milestones using appropriate tools.
⦁    Develop and implement solutions to validation issues. 
⦁    Present validation systems program during internal and external audits.
⦁    Perform all other related duties as assigned.

Job Qualifications

⦁    Education:  Bachelor’s degree (B.A./B.S.) or equivalent in computer science, scientific or related discipline. 
⦁    Experience:  5-7 years related experience in Computer System Validation. Prior experience working in a GxP laboratory is preferred.
⦁    An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
⦁    Certification/Licensure: Test or validation certification desired.
⦁    Other:  Comprehensive knowledge of regulatory requirements, including GxPs, 21 CFR Part 11, and Annex 11 as they pertain to computerized systems, is preferred. Excellent organizational and analytical skills and demonstrated ability to shift priorities to meet a constantly changing environment.  

PHYSICAL DEMANDS:
⦁    Must regularly operate a computer and occasionally operate other office productivity machinery such as a calculator, copy machine, and computer printer. 
⦁    Must regularly communicate with employees/customers; must be able to exchange accurate information.
⦁    Must occasionally move about inside the office to access file cabinets, office machinery, etc.
⦁    The employee may be required to lift and/or move up to 25 pounds and occasionally lift and/or move more than 50 pounds. 

WORK ENVIRONMENT:
⦁    General office working conditions.
⦁    The noise level in the work environment is usually quiet.

Comments:
⦁    This position may require occasional domestic and international travel.

Compensation Data

The pay range for this position is $93,000 to $98,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.

Competencies