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, they 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.
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
Must pass drug test, background check and must have a satisfactory driving record in accordance with the Company's driving (MVR) policy
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
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.
About Amec Foster Wheeler Environment & Infrastructure, Inc.
Amec Foster Wheeler (www.amecfw.com) designs, delivers and maintains strategic and complex assets for its customers across the global energy and related sectors.Employing around 36,000 people in more than 55 countries and with 2015 revenues of £5.5 billion, the company operates across the oil and gas industry – from production through to refining, processing and distribution of derivative products... – and in the mining, clean energy, power generation, pharma, environment and infrastructure markets. Amec Foster Wheeler offers full life-cycle services to offshore and onshore oil and gas projects (conventional and unconventional, upstream, midstream and downstream) for greenfield, brownfield and asset support projects, plus leading refining technology. Amec Foster Wheeler shares are publicly traded on the London Stock Exchange and its American Depositary Shares are traded on the New York Stock Exchange. Both trade under the ticker AMFW.