Job description
:
Our Burlington office has been established for over ten years working for major multi-national clients including AbbVie, Alexion, Avecia, Regeneron, EMD Serono and Sanofi. Services range from master planning, concept design, architecture, engineering, procurement, commissioning, and validation.
Who we are
PM Group is an employee owned, international project delivery firm with a team of 3,700+ people. We are world leaders in the pharma, food, biotech, medical technology and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organizations. We are focused on growing a sustainable business centered on our people, our clients and trade partners. :
Why PM Group?
Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future.
PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know.
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RECRUITMENT AGENCIES NEED NOT APPLY
We have an opening for a
CQV Engineer. In this role, you will work on various client projects from conceptual to completion (as applicable) and be responsible for key CQV deliverables as part of the multi-disciplinary project teams. The CQV Engineer will interface between their discipline, the client, and other disciplines per the project scope, schedule, and budgeted hours. Liaise with senior colleagues and mentors as appropriate. This is an exciting opportunity for the successful candidate to become part of a growing and dynamic team/department within Burlington's operation.
Our Burlington office has been established for over ten years working for major multi-national clients including AbbVie, Alexion, Avecia, Regeneron, EMD Serono and Sanofi. Services range from master planning, concept design, architecture, engineering, procurement, commissioning, and validation.
Who we are
PM Group is an employee owned, international project delivery firm with a team of 3,700+ people. We are world leaders in the pharma, food, biotech, medical technology and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organizations. We are focused on growing a sustainable business centered on our people, our clients and trade partners.
- Become familiar with the user, functional, installation, operation, and performance requirements for assigned projects and tasks.
- Generates and executes life cycle documentation (FAT, SAT, IV, OV, IOQ, PQ) for cleaning, sterilization, shipping, facilities, utilities, systems, equipment, and processes for qualification/verification.
- Review requirements and source documentation P&IDs, RDs, URSs, SOPs, Specifications) for use in the development of equipment commissioning and validation documents.
- Equipment validation protocol development, including drafting documents, managing review cycles and protocol approval.
- Support Validation Master Plan development
- Execution of equipment validation protocols, including the generation of Equipment Validation Reports.
- Preparation and processing of turnover packaging and validation documentation in EDMS (electronic document management system).
- Provide support for generation, resolution, and closure of Equipment Validation related deviations and required documentation.
- Assist with coordination of activities between Client teams (validation, engineering, manufacturing, QC, etc.).
- Support resolution of engineering/validation issues found during equipment validation.
- Attending meetings as required to support equipment installation and operation
- Providing quality oversight and approval for validation documents as needed. (Function test, IQs, OQs, etc.…)
- Support developing SOPs
- Uses initiative in problem-solving and can make decisions under the direction of others.
- 1-3 Years of Equipment Validation experience working within a cGMP & FDA Regulated environment
- Bachelor’s Degree in Engineering / Science preferred.
- Previous Experience with CQV activities for equipment outlined above.
- Computer literate with good Experience in MS Word and Excel
- A basic understanding and knowledge of equipment and automated systems is desired.
- Previous Experience working in a cGMP and FDA-regulated environment
- Working knowledge of FDA and cGMP regulations and documentation practices.
- Strong work ethic
- Good communication skills, both verbal and written, and the ability to work within a multi-discipline team environment
- Supporting engineer will be resident at the Client facility or a previously agreed upon location (i.e., vendor’s location).
All of your information will be kept confidential according to EEO guidelines.
Why PM Group?
As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy. Click here to read more in our
Corporate
Responsibility
and Heath, Safety & Wellbeing Report 202
2
.
Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future.
PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know.
#LI-CG1
RECRUITMENT AGENCIES NEED NOT APPLY
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