Computer Systems and Equipment Validation Engineer - Consultant

  • Main St, St. Louis, MO 63136, USA
  • Contract

Company Description

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

Job Description

 

  • Responsible for the Computer System Validation processes of the company.
  • Maintain expertise in current and emerging cGMP 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 efforts and be the primary client contact for coordinating work, reporting status, resolving issues, and addressing change orders as they apply.

 

Qualifications

 

  • Bachelor’s degree in scientific or engineering discipline along with 7 plus years of experience in the field of computer validation.
  • Ideal candidate will have a Laboratory Systems Background (LIMS) and Laboratory Equipment (HPLC, GC, AA). Previous experience working with higher level systems including: Trackwise and ERP.
  • Previous automation experience (preferred).
  • Considered a Subject Matter Expert (SME) in terms of qualification for at least one type of system. Individual will work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule.

  • Demonstrate expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR) and internal requirements employing regulatory guidance and industry standards.
  • Candidates 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, 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 at least one area of systems validation – e.g., laboratory equipment, facilities utilities, manufacturing equipment, metrology equipment, information systems.
  • Effective written and oral communication skills; ability to write, type, express or exchange ideas; ability to convey information/instructions accurately.
  • Ability to plan and manage own work
  • Must be willing to travel regionally and/or nationally throughout the US.

We are an equal opportunity employer. M/F/D/V

 

Qualified candidates must be legally eligible to work for any employer in the United States.

 

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

 

Additional Information

All candidates must be legally eligible to work in the United States.

We are an equal opportunity employer. M/F/D/V

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***