Computer System Validation Engineer

at  Bell People Consultants

Melbourne, Victoria, Australia -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate16 Jul, 2024Not Specified17 Apr, 20245 year(s) or aboveLife Sciences,Project Management Skills,Automation,Pharmaceutical Industry,ScadaNoNo
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Description:

THE SUCCESSFUL CANDIDATE WILL HAVE THE FOLLOWING SKILLS & EXPERIENCE:

  • Tertiary Qualifications in IT Computer systems.
  • Minimum 5 years experience in CSV methodologies within the pharmaceutical industry.
  • Demonstrated knowledge & experience in CSV regulations & SDLC guidelines for life sciences & best practices.
  • Experience with Automation & MES Project highly desirable.
  • Sound experience in DCS, PLC & SCADA.
  • Manage different stakeholders & arrange meetings.
  • Strong project management skills.

Responsibilities:

  • Define validation strategies for CSV systems, maintain & support IT Quality related process.
  • Execute CSV deliverables, write and review CSL documentation (IQ, OQ & PQ) plans, reports, specifications & other documentation.
  • Plan & coordinate all computer systems validation activities including the drafting & review of all key validation documentation.
  • Coordinate all validation documentation ensuring all documents are written to global standards.
  • Effectively liaise with all stakeholders and Subject Matter Experts.


REQUIREMENT SUMMARY

Min:5.0Max:10.0 year(s)

Pharmaceuticals

IT Software - Other

Clinical Pharmacy

Graduate

Proficient

1

Melbourne VIC, Australia