Amec Foster Wheeler is currently seeking a CQV Project Manager to work in the field on pharmaceuticals, biopharmaceuticals, vaccines, and fill finish/aseptic processing. Working at client sites,
This position involves leading and managing CQV projects. This includes managing the project scope, schedule, and budget, while leading a team of CQV specialists to ensure a successful delivery. 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. Responsible for tracking documents, reporting on project progress and projections, and initial review of documents prior to client review.
Must be capable of working effectively with a multi-disciplinary team, maintaining and reporting on project scope and schedule, and interfacing effectively with clients. Must be capable of identifying new business opportunities for Amec FW and working with colleagues and clients in securing additional business. Responsible for workload assignment to other project team members as well as review of team member performance, quality review of deliverables, establishing project staffing needs.
Key Responsibilities •Lead and Manage CQV projects •Track project scope, productivity, earned value •Manage integrated CQV schedule •Lead the CQV team •Manage project client relationships •Depending on project size, may require preparing and executing CQV life cycle deliverables, URS/DR/DQ/Risk Assessments/CTP/FAT/SAT/IOQ/PQ/PV/TOPs •Quality review of CQV deliverables generated by project team members •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 12 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 •Ability to multi-task and adjust priorities to meet aggressive project timelines •Understanding of common unit operations used in pharmaceutical manufacturing •Thorough knowledge of cGMPs as related to pharmaceuticals •Strong computer skills, including MS Project
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 20 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.
About Amec Foster Wheeler Environment and 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.