PM Group · 1 day ago
CQV Engineer II
Richmond, VA
Full-time
Onsite
Entry, Mid Level
2+ years expPM Group is an employee-owned, international project delivery firm with over 50 years of industry experience. The CQV Engineer II will support Aseptic Process Simulation activities within sterile filling operations, collaborating with various teams to ensure compliance and improve aseptic processing programs.
Architecture
Responsibilities
Draft and execute APS (media fill) protocols, batch records, engineering study protocols, and summary reports for sterile filling lines
Develop and support aseptic intervention work instructions, risk assessments, and pFMEAs with cross-functional teams
Provide on-floor oversight and execution support of APS and mock APS batches
Support airflow visualization (AVS / smoke study) protocols and reporting
Perform qualification protocol execution and documentation in compliance with CGMP and CGDP
Collaborate with Operations, Quality, Engineering, and Validation teams in sterile manufacturing environments
Qualification
Required
Bachelor's degree required; engineering degree preferred
2+ years experience in sterile/aseptic GMP manufacturing environments
Candidates must have hands-on APS/media fill execution experience. Experience limited to CQV/cleanroom qualification or general aseptic readiness without direct APS execution will not meet the requirements of this role
Hands-on experience in GMP sterile manufacturing supporting aseptic processing on vial, syringe, and/or cartridge filling lines
Proven ability to draft and execute APS documentation and batch records
Experience supporting multiple APS/media fill executions in a GMP environment
Experience developing intervention WIs, risk assessments, and pFMEAs
Experience supporting AVS / smoke studies
Ability to clearly describe personal role during APS execution (interventions, documentation, deviation support)
Understanding of validation lifecycle, change control, and CGDP
Strong technical reporting and writing skills
Ability to travel as needed for client development and project execution
Company
PM Group
PM Group is an international project delivery firm providing professional services in architecture, engineering and construction.
1001-5000 employees
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)
Funding
Current Stage
Late StageLeadership Team
Sam B.
CEO
Recent News
Irish Examiner
2025-09-13
2025-09-12
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