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PM Group · 1 week ago

CQV Engineer III

Conshohocken, PA

Full-time

Onsite

Mid, Senior Level

5+ years exp

PM Group is a rapidly growing company in the Philadelphia area, focusing on cutting-edge projects for Cell & Gene Therapy, Biologics, and Pharma facilities. The CQV Engineer III will be responsible for document development, testing execution, and client interaction while supporting qualification needs across various projects.

Architecture

Growth Opportunities

H1B Sponsor Likely

Responsibilities

Performs work in compliance with PM Group’s Service Delivery Platforms and Quality Management System (QMS)

Independently interact with client to asses and continuously reassess client needs

Perform quality GAP analysis

Author technical and scientific reports

Demonstrates an understanding of project scope of work assigned

Demonstrates an understanding of commercial aspects (hours and capital cost) of their work

Delivers scope of work within budgeted hours

Document development as well as testing execution to meet client qualification needs

Applying the principals of good documentation practices (CGDP)

Collaborate in a multi discipline team environment

Perform qualification protocols and review other team members qualification documents

Ensure the implementation of current good manufacturing practices (CGMP)

Independently assess the qualification needs of equipment, facilities, utilities and systems

Provide technical guidance to less experience CQV team members

Special projects as assigned

Qualification

CQV experienceFactory site acceptance testingCommissioning functional performance testingCurrent good manufacturing practicesUser requirements specificationsValidation life cycle understandingCleaning validation proceduresTechnical report writingDesign drawings understandingSoft skills

Required

Bachelor's degree is required; an engineering degree is preferred

5-10 Years of CQV experience in the Pharmaceutical, Life Sciences, Biotech and/or Cell & Gene Therapy industries

Factory site acceptance testing (FAT) and site acceptance testing (SAT) experience

Proven experience with commissioning pre-functional checklist (PFC) development and commissioning functional performance testing (FPT)

Experience working with current good engineering and current good manufacturing practices

Understand client needs and provide assistance with the development of user requirements specifications (URS) and system impact analysis (SIA)

Demonstrated experience working in an industry regulated life sciences environment

Actively participant in the document approval process

Understanding of the entire validation life cycle and change control process

Experience reviewing vendor supplied documents such as submittal sheets and turn over packages (TOPs)

Familiar with and understand the basics of design drawings

Full understanding of all commissioning, qualification and validation (CQV) testing procedures

Ability to document and execute cleaning validation procedures

Knowledge of cGMP Manufacturing environments is required

Good technical reporting writing skills are mandatory

The ability to travel as needed for client development and project execution

Company

PM Group

Glassdoor4.3

PM Group is an international project delivery firm providing professional services in architecture, engineering and construction.

Founded in 1973

Diegem, Vlaams-Brabant, BEL

1001-5000 employees

http://www.pmgroup-global.com/

H1B Sponsorship

PM Group has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (2)

2023 (3)

2021 (1)