Overview / Responsibilities Amec Foster Wheeler is currently seeking a Senior CQV Specialist to work in the field on pharmaceuticals, biopharmaceuticals, vaccines, and fill finish/aseptic processing. Working at client sites, This position involves working independently on projects as well as assuming a lead role on larger projects as part of the overall project team. Must be thoroughly familiar with cGMPs and pharmaceutical, and biopharmaceutical unit operations. Must be capable of authoring and executing DQ/FAT/SAT/CTPIQ/OQ/PQ/PV, developing SOPs, final reports and author/adhere to the validation and quality policies/procedures/guidelines. Thoroughly familiar with bioprocess unit operations, support systems, process utilities, and environments. Key Responsibilities •Preparation and execution of CQV life cycle deliverables, URS/DR/DQ/Risk Assessments/CTP/FAT/SAT/IOQ/PQ/PV/TOPs/Final reports•Quality review of CQV deliverables generated by project team members•P&ID walk downs•Punch List and Deviation resolution•Effectively interfacing and communicating with clients and CQV project team•Ability to multi-task and adjust priorities to meet aggressive project timelines•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 8 years of experience in CQV•Strong communication skills, both written and verbal, are essential•Ability to effectively interface with AmecFW management, co-workers, as well as clients•Understanding of common unit operations used in pharmaceutical manufacturing•Thorough knowledge of cGMPs as related to pharmaceuticals•Strong computer skillsPhysical 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 20 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.