Sr. Specialist, Computer System Validation
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
By providing a foundation for all operations company wide, BioMarin’s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases. Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology. Come join our team and make a meaningful impact on patients’ lives.
This position is responsible for review and approval of computer validation activities in a GxP regulated environment, focused primarily on Enterprise Systems. Will participate in the development of custom programs, as well as configurable off the shelf (COTS) systems. Duties include ongoing evaluation and periodic review of existing validated computer systems; change control; and validation of new computer systems. Other responsibilities of this position include: generation of validation plans, review and approval of SDLC documents, generation of test scripts/protocols; review and approval of protocols, execution of protocols; review of execution work, generation of final report; final package review and approval, validation contractor management and other duties as assigned. The position may require minimal travel to perform software vendor audits.
- Developing validation plans for specific computer system implementation projects.
- Working closely with Information Management, Quality Assurance and system owners to effectively and efficiently implement new systems, system upgrades, or system modifications.
- Assisting with design of computer validation testing in coordination with BioMarin policy and procedures.
- Assist in development, implementation, and enforcement of computer validation policies and practices.
- Partner closely with the business to ensure that CSV methodologies are well understood and applied in a manner that will produce the most value.
- Protocol, execution work, and final report review and approval.
- Participation in the change control program for modifications to qualified systems.
- Manage consultants to ensure that project timeline, budget, and quality are maintained.
- Ability to present and defend validation data at multi-department meetings.
- Coordination between internal departments, including Manufacturing, Information Management, Quality Control, Quality Assurance, Corporate Compliance, Facilities, Technical Operations and Research & Development and others.
- Good verbal and written communication skills.
- Good organizational skills.
- Experience coordinating contract staff, and/or experience in project management.
- Must have good interpersonal skills. Position will require a good deal of interdepartmental interaction and coordination.
- Must possess a thorough understanding of GxPs, in addition to FDA and International requirements for computer validation and Part 11 requirements.
- Must possess a thorough understanding of current industry guidance, including GAMP 5, Data Integrity and LEAN validation principles.
- Must have direct experience with computer validation and determining computer validation approach, including enterprise platforms systems as well as custom software projects.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.