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. 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 pharmaceuticalsPhysical 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 requiredDiversity 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.