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Pharmaceutical – IT CSV SPECIALIST

2 months ago

Bengaluru, India MMR Consulting Full time

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industries. Its services include Engineering, Project Management, and Validation. MMR has offices in Canada, USA, and Australia.

This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers and specialists involved in project management, commissioning and qualification, of equipment, systems and facilities.

This role is for an IT CSV Specialist to work remotely on the CSV of GxP IT systems in the pharma/biotech industry, such as ERP, QMS, MES and IT Infrastructure. The ideal candidate should possess leadership skills to lead/mentor junior specialists.


Responsibilities

  • Lead the development of key validation deliverables during the project lifecycle to ensure project is well defined, and the action plan to test the system is applicable and relevant.
  • Lead validation processes throughout the project lifecycle such as VPP, Risk Assessments, RTM, RA, DQ, CS, FAT, SAT, IQ, OQ and PQ as appropriate to ensure timely completion and to ensure all quality and engineering specifications are met.
  • Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports.
  • Engage other departments, as required, for design reviews and decisions.
  • Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phases.
  • Client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
  • Other duties as assigned by client, and/or MMR, based on workload and project requirements.

Qualifications

  • Excellent written and spoken English is required including the preparation of technical documents in English
  • Understand Data Integrity requirements.
  • GAMP 5 CSV and V-Model experience is required
  • Must have experience in one of these 3 CSV of ERP, QMS or MES systems
  • IT infrastructure experience is an asset, but not required.
  • Years of experience: 4+ years for years of experience in IT GxP computer system validation.
  • Knowledge of requirements for a cGMP operation, including SOPs, Change Controls, Validation.
  • Experience with developing and executing validation projects.
  • Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity.
  • Possess mentorship skills, to coach and develop junior and intermediate employees.
  • Engineering or Science degree, preferably in Mechanical, Electrical, Electromechanical, Chemical, Biochemical or a related discipline.