CQV Engineer II

PM Group • Richmond, VA

8d • Onsite

About The Position

The CQV Engineer II position is an exciting opportunity to join PM Group’s quickly growing Southeast USA area Outsourced Technical Services(OTS) team at a client site in Richmond, VA area. Outsourced Technical Services (OTS) is an integral part of PM Group’s ability to support clients across the complete project life cycle. We have over 50 years’ industry experience, strong technical knowledge and integrated resources. Clients look to us to provide experienced technical professionals that complement their project teams. Together we are sharing knowledge, learning, growing and continuing to be an integral part of supporting PM Group’s ongoing expansion in the US.
This role is specifically focused on supporting Aseptic Process Simulation (APS / Media Fill) activities within sterile filling operations. The CQV Engineer II will work directly with Operations, Quality, and Engineering teams to support the execution, documentation, and improvement of aseptic processing and media fill programs on vial, syringe, and cartridge filling lines. This position requires hands-on sterile manufacturing experience combined with strong documentation and validation skills in a GMP environment.
PM Group is an employee owned, international project delivery firm with a team of 4,000+ 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.

Requirements

• Bachelor’s degree required; engineering degree preferred
• 2+ years experience in sterile/aseptic GMP manufacturing environments
• Required APS / Media Fill Experience
• 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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level