CQV Project Manager
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.
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
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.
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
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