0042 COMMISSIONING & QUALIFICATION ENGINEER

  • Tiempo completo
  • Holland
  • No. of Vacancies: 1
  • Experience: 3 - 5 Years
  • Posted 3 años ago

Engineering / equipment commissioning and qualification, not process validation.

General:

Minimum qualifications:            

Technician Engineer – HBO / National Certificate / Level 5

Qualities:          

·         Ideally an “All Rounder” with a minimum 3 – 5 years life sciences experience

·         Conversant with the principles and practice of GMP & GDP

·         Fully conversant with the principles and practice of engineering commissioning & qualification in the pharmaceutical industry

·         Understands, and believes in, the Commissioning & Qualification lifecycle process.

·         Understands the principles and practice of ASTM E2500

·         Understands the Risk Based Approach to Commissioning and Qualification

·         Ability to plan and execute high level System Impact Assessments and low level Component Criticality Assessments

·         Proficient in the drafting & review of Commissioning and Qualification Protocols:     IC, OC, IQ, OQ, PQ

·         Proficient in executing and reporting Commissioning and Qualification activities:

Experience:

Some of the following:

·         Facilities & HVAC

·         Clean Utilities

·         Solid Dosage Manufacturing

·         Powder handling

·         Controlled Temperature Storage Units / Areas

Application Deadline: 31 diciembre, 2018