Computer System Validation Specialist
6701 Kaiser Drive Fremont, CA 94555
Bayside Solutions is seeking a Computer System Validation Specialist to be part of our client’ s team in the East Bay. This is an opportunity to work with one of the largest Biopharmaceutical companies in the world developing innovative medicine to improve the quality of patients’ lives.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Computer System Validation Specialist
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Provide risk assessment for new computer systems and changes to existing computer systems
- Write validation plans, protocols and reports
- Execute and provide reviews of validation protocols and validation periodic monitoring
- Lead or participate in project team including the supervision of validation contractors
- Plans and executes validation aspects of computer system project portfolio
- Provides project estimates of validation resource requirements
- Supports audits and inspections related to computer systems
- Bachelors’ Degree in computer science, computer engineering, information technology, life science or engineering, from an accredited university or college.
- Greater than 10 years of relevant cGMP biopharmaceutical manufacturing environment experience in computer system validation.
- At least 5 years must be recent experience with validation of typical GMP manufacturing computer systems at a pharmaceutical manufacturing facility.
- Experience leading computer system validation projects in a GMP environment
- Experience supporting at least three of the following business-process supporting technology platforms: MES, LIMS, Lab Systems, quality systems (change control, deviation, CAPA), document management, training
- Deep technical knowledge of enterprise computer systems (IT infrastructure, software design, software development, system architecture, distributed systems, system integration, and/or software maintenance)
- Knowledge of validation lifecycle approach and international regulatory requirements
- Validation experience using risk based approach
- Outstanding technical writing and verbal communication skills
- Ability to work as part of a high performing team and collaborate effectively with staff at all levels. Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the company.
- Demonstrated ability to manage multiple activities while maintaining a high level of organization
- Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
- Experienced in Microsoft Office Suite