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CQV Project Manager

CQV Project Manager

Requisition ID 
2017-19321
Work Location 
US-FL-Miami Lakes
Department / Discipline 
Pharmaceuticals
Additional Work Location 
..
Position Type 
Staff / Permanent

Job Description

Overview / Responsibilities

Amec Foster Wheeler is currently seeking a CQV Project Manager to work in the field on pharmaceuticals, biopharmaceuticals, vaccines, and solid oral dosage. Working will be performed 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 Amec Foster Wheeler 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.

 

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