PharmEng Technology is a global ISO certified Pharmaceutical Compliance Consulting Firm with projects around the world providing quality services to the manufacturers of pharmaceutical and health care products for over 25 years.

 PharmEng Technology is a cGMP compliant leader with international offices in Canada, Spain, France, Switzerland, Singapore, Malaysia, Indonesia, Taiwan, Ireland, Denmark, Brazil and USA and maintains strategic partnerships for extended capabilities internationally.

PharmEng Technology is seeking a skilled Computer System Validation (CSV) Consultant for a project in Occitania, France. English and French speakers are welcome. Bilinguals are a plus.

Key Responsibilities

• • Perform computer system validation (CSV).
  • Configure and validate virtual machines and host hardware.
  • Ensure data migration from legacy systems to new platforms is accurate and efficient.
  • Verify integration and connectivity with systems..
  • Proficiency in CSV.

Scope Of Services

• • Provide support for commissioning and qualification activities..
  • Author and execute relevant commissioning and qualification documents, including:
  • • User Requirement Specifications (URS)
    • Qualification Plans
    • Development Protocols
    • Specifications (Configuration, Software, Design, Functional)
    • Risk Assessments
    • Qualification Protocols (including deviation support)
    • Qualification Reports
  • Ensure alignment of design specifications with qualification strategy and procedures.
  • Stay informed about project updates, changes, and issues.
  • Attend meetings related to implementation, document reviews, and schedule reviews.
  • Track deliverables and milestones, escalating delays to Validation Management.
  • Report project or technical changes, issues, risks, and outstanding decisions to Validation Management.

  Required Qualifications:

  • Bachelor’s degree in business/technical area or comparable education/experience.
  • English and French speakers are welcome. Bilinguals are a plus.
  • Experience in Computer Systems Validation within the pharmaceutical/biotechnology GMP environment including authoring and execution of IOQ/PQ’s, experience in performing traceability matrices, risk assessments.
  • Strong technical skills in hands-on configuration of a variety of Laboratory systems including Standalone instruments such as Mass Spec, IC, Matersizer, UV, FTIR, DSC etc.
  • Excellent Desktop Operating system knowledge with respect to Permissions, configuring users and connecting to peripheral devices.  Including Windows 2000, Windows 7 and Window 7
  • Drive mapping, logon scripts, Analyzing System logs.
  • An advanced understanding of security of data systems for the protection of electronic assets, intellectual property, and privacy.
  • Experience in developing and implementing complex data exchange technology processes between information systems.
  • Experience in creating/developing a moderate to complex functional requirement mapping to an Information System based on user requirements.
  • Ability to independently identify compliance risks and escalate when necessary.
  • Must have proven ability to lead a team