Senior Computer Systems Validation Specialist

Location
San Francisco, CA, United States
Posted
Apr 05, 2019
Ref
449
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
SENIOR COMPUTER SYSTEMS VALIDATION SPECIALIST

Position Summary:

GBT places a high value on cooperative team dynamics and a positive, "can-do" work ethic. The ideal candidate thrives in a fast-paced environment where a strong sense of urgency is the norm and exceptional communication and interpersonal skills are needed.

Essential Duties and Responsibilities:

  • Performs CSV projects related to authoring and executing specifications and validation documentation according to the GAMP5 Validation Life Cycle, including: Validation Plan, System Requirement Specification (SRS), Risk Assessments, Functional Requirement Specification (FRS), Design Specification (Software and Hardware), Commissioning, IQ, OQ, PQ, Summary Reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems and Audit Trail review
  • Draft validation protocols in line with corporate guidelines procedures, cGMP and ISPE GAMP guidelines and regulations
  • Draft a CSV validation plan detailing the scope of work and intent
  • Identify specific tests and requirements to be met in the IQ/OQ/PQ that address requirements.
  • Ensure all work is in line with Validation Plan, regulations, procedures and practices.
  • Review and execute Computer System Validation protocols
  • Draft risks assessments and applicable test scripts
  • Prepare validation summary reports for executed protocols
  • Liaise with other departments (Technical Operations, Clinical Operations, Regulatory Affairs, IT) in execution of the Validation program
  • Anticipate and assess/prevent technical problems from impacting product and processes
  • Work with Business Owner(s) and System Owner to ensure the validated state of the system with change control activities
  • Participate in and track Computer System Change Controls
  • Track and resolve deviations/exceptions during qualification activities
  • Assist in the development of training material for qualification activities
  • Participate in cross functional teams as defined by manager
  • Communicate and ensure compliance with Quality objectives, policies and procedures

Qualifications:
  • Bachelor's degree in business/technical area or comparable education/experience
  • Hands-on experience in CSV in the pharmaceutical industry, or related industry. Title and responsibilities to commensurate with experience. Minimum 2-3 years of experience
  • Knowledge of FDA guidelines and Global cGMPs relevant to 21 CFR Part 11 compliance requirements and Global Computer System Validation and ISPE GAMP guidelines
  • Ability to establish clear priorities
  • Ability to work effectively under pressure, handle multiple projects and meet deadlines
  • Ability to write technical documents (Validation plan, URS, FRS, Traceability Matrix, IQ/OQ protocol and report etc)
  • Ability to independently identify compliance risks and escalate when necessary
  • Excellent interpersonal skills with the ability to influence individual and teams across the organization in the absence of a direct reporting relationship
  • Able to work collaboratively in a matrix structure while ensuring that timelines and deliverables are met
  • High energy, enthusiasm and excellent leadership and management skills
  • Strong verbal and written communication skills, good decision-making skills and time management skills is a must; ability to interface with all levels of the organization
  • Knowledge in risk assessment, gap analysis, changes control and deviation management

Fit with GBT culture:
  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity

NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.