Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.
Responsible for supervision and management of the validation responsibilities at the La Jolla site. This includes planning, staffing, ensuring proper resources and compliance of the validation program for facilities and equipment.
Responsibilities also include the reviewing and development of validation procedures to ensure products meet appropriate regulatory validation requirements, company requirements and customers.
Serves as information resource for Validation department, contractors, vendors, internal and external customers.
Responsible for updating the Facility and Equipment portions of the validation master schedule, and the coordination of current and future projects related to facility and equipment validation with the functional areas affected.
Responsibility for trouble-shooting and working through validation issues as they arise. Exercises judgment within defined procedures and practices to determine appropriate action.
Will act as Validation representative internal/external audits and for change control procedures as required.
Primary Duties and Responsibilities: (Listed in order of importance, most important first, provides details on what this position does and why. Indicate percent of time spent in each activity.)
Validation Personnel Management: Provide direction and management to validation department and program as well as other departments regarding validation policies and requirements. Ensure adequate staffing and resources, delivery on projects, validations and milestones and makes adjustment and required. Ensure proper training of validation staff and validation training throughout the organization.
Validation Program Management: Coordinate validation activities, troubleshoot efforts relating to validations, planning, schedules, review/approve system change request, maintain Validation Master Plan.
Write selected studies and protocols for equipment or systems.
Execute selected studies and protocols for equipment or systems.
Keep abreast of current technology by attending professional meetings and seminars and reading technical literature.
Calibrate and set up validation equipment.
Develop, administer and control validation budget and performance requirements.
Assignments as directed by manager.
Positions Directly Supervised:
Senior Validation Engineers
Associate Validation Engineers
BS degree in a scientific discipline or equivalent with 5 to 8 years related experience or a minimum of 8 to 10 years validation experience without a degree.
A minimum of 2 years leadership experience.
Validation techniques, requirements and strategies.
Kaye Instruments Data loggers or equivalent
Current Validation Technology/Requirements
Statistical Process Control
AAMI Sterilization Guidelines
Solid background and experience level of GMPs
Aseptic Process Validations
Part 11 and Software Validation Guidelines
Leadership experience and strong interpersonal communication skills
Good written skills required for writing protocols and standard operating procedures.
Good communication skills required for interactions with internal departments and outside vendors and contractors.
Physical Requirements/Working Environment:
Must be able to lift 40lbs.
Must be able to gown and work in cleanrooms.
This position requires this person to inform and provide direction to:
- Outside contractors and vendors, internal customers and staff.
- Interact with internal and external auditors
- This position requires strong customer service interactions with the following internal departments:
- Manufacturing, Engineering, Product Development, Quality Assurance and Quality Control.
Implements and enforces company environmental, health and safety policies and requirements within areas of responsibility.
Shire is an Equal Opportunity and Affirmative Action Employer
Shire - 18 months ago
Shire plc (Shire) is a specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its...