Sr Validation Lead, Data Integrity

Type: 1 year contract

MUST have past Pharmaceutical or Biotech experience as a strong understanding of GxP will be crucial for this position. 

Job Description:

• Computer System Validation processes expert.
• Maintain expertise in current and emerging GMP requirements and quality trends (e.g., 210, 211, 820, and 21 CFR Part 11).
• Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule.
• Lead system qualification effort and be the primary contact for coordinating work, reporting status, resolving issues, and addressing change orders as they apply.
• Demonstrate expertise in system qualification and regulatory compliance and internal requirements employing regulatory guidance and industry standards.
• Qualified Computer System Validation Engineer candidates must be willing to travel throughout the US for project work.

Qualifications:

• Bachelor's degree in scientific or engineering discipline along with 10 plus years of experience in the field of computer validation.
• Ideal computer system validation engineer will have a Laboratory Systems Background (LIMS) and Quality Systems. Previous experience working with higher level systems.
• Demonstrate expertise in system qualification and regulatory compliance and internal requirements employing regulatory guidance and industry standards.
• Computer System Validation Engineers must have excellent verbal communication and technical writing skills.
• Experience with all pertinent industry best practices (e.g., ISPE GAMP) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing,Delta V, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report).
• Working knowledge of the development of protocols for the Validation of complex computer systems (e.g., multiple GAMP classes of systems); Protocol development will include ability to develop Installation, Operational and Performance qualification documents.
• Experience in Project execution within systems validation – quality systems
• Ability to plan and manage own work

Computer System Validation Engineer must be willing to travel regionally and/or nationally throughout the US.