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CQV Specialist

CQV Specialist

Requisition ID 
2017-17756
Work Location 
US-PA-Philadelphia
Department / Discipline 
Pharmaceuticals
Additional Work Location 
..
Position Type 
Staff / Permanent

Job Description

Overview / Responsibilities

Amec Foster Wheeler is currently seeking a CQV Specialist to work in the field on pharmaceuticals, biopharmaceuticals, vaccines, and fill finish/aseptic processing. Working at client sites, will author and execute Commissioning, IQ/OQ/PQ documents, develop SOPs, and author/adhere to the validation policies/procedures/guidelines. CQV specialists work on pharmaceutical unit operations (cell culture, harvest, purification, filling, packaging), pharmaceutical grade utilities and support systems is preferred.  

 

Location

NY/NJ/PA area

 

 

Key Responsibilities

  • Prepare and execute commissioning, IQ/OQ/PQs protocols
  • Review of system turnover packages
  • Documentation and resolution of punch list items and deviations
  • Reporting of planned and completed activities to management and adherence to project schedules
  • Understand and implement the leveraged approach to commissioning and qualification
  • Ability to ready P&IDs, red line P&IDs to as built conditions
  • Responsible for tracking documents, progress and projections
  • Use of validation test equipment, such as the Kaye Validator
  • Since work is completed at client sites, the ability to travel is essential

Skills / Qualifications

  • Degree in engineering (preferably) or life sciences or suitable industry experience.
  • Minimum of 3 years of experience in CQV
  • Strong communication skills, both written and verbal, are essential.
  • Ability to effectively interface with AFW management, co-workers, as well as clients
  • Understanding of common unit operations used in pharmaceutical manufacturing.
  • Thorough knowledge of cGMPs as related to pharmaceuticals

Physical Requirements

  • While performing the duties of this job, the employee is frequently required to walk, sit, and stand and may require close vision work
  • In addition, may carry drawings or boxes up to 15 pounds
  • Ability to work at an active construction site is required

Diversity Statement

We are an equal opportunity employer that recognises the value of a diverse workforce. All suitably qualified applicants will receive consideration for employment on the basis of objective criteria and without regard to the following (which is a non-exhaustive list): race, colour, age, religion, gender, national origin, disability, sexual orientation, gender identity, protected veteran status, or other characteristics in accordance with the relevant governing laws.

 

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