San Francisco, CA

The candidate will be a part of the ICQ Consultants team and will be responsible for the development and execution of protocols and final summary reports for Computer System Validation (CSV) activities.

• 2 to 6 years of Computer System Validation with additional CQV experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
• Experience writing protocols, performing execution for processes, equipment and utilities used in the Biotech or Pharmaceutical Industry.
• Direct experience within the following areas; Computer System Validation (CSV), Data Integrity, 21CFR Part 11, ERES, Enterprise Systems Qualification, Master Validation Plans, Standard Operating Procedure (SOP), Change Control, Data Analysis, Deviations, Risk Assessments, CAPAs, GMP investigations, Quality Risk Management (QRM).

• Successfully working within a multi-disciplinary team coordinating and delivering project activities meeting schedule, budgetary and quality expectations of the client.
• Customarily and regularly exercises discretionary and independent judgment in performing the job.
• Participate in training to ensure continued accreditation.
• Maintain a safe working environment for self, team members and client staff.
• Other tasks in alignment with your skills and competencies as required by the project, client and/or management.

• Excellent organizational, verbal, and written communication skills; with demonstrated ability to efficiently and effectively, communicate with cross-functional teams and management on recommended course of action, with minimal assistance.
• Proficient computer skills and be experienced using MS Office software (Word, Excel, and PowerPoint) and MS Project (as needed).
• A self-starter, detail oriented and able to work independently with minimal supervision.
• Excellent troubleshooting skills: ability to react quickly to understand and solve problems.

B.S. degree in Biology, Biochemistry, Chemistry, Engineering, or equivalent years’ experience working in FDA-regulated industries.