We are seeking an experienced Validation Engineer to support the qualification and validation of filling equipment at our biologics CDMO. The ideal candidate will have a strong background in validation, particularly with filling devices, and be able to effectively communicate and coordinate with various teams, including QC labs, material science, and operations.

Responsibilities of the Validation Engineer:

• Conduct Aseptic Process Simulation (APS) by filling media to promote growth, incubating containers, and making interventions to identify contamination risks. Capture all interventions and develop protocols to ensure equipment quality.
• Perform smoke studies to ensure laminar airflow and identify any turbulence.
• Collaborate with vendors on vaporized hydrogen peroxide (VHP) cycle development to verify kill rates using biological and chemical indicators. Validate the cycle and place indicators as needed.
• Oversee cleaning validation for single-use and indirect parts, ensuring sufficient silicone removal and preventing contamination transfer.
• Conduct media fills, smoke studies, decontamination, and cycle validation, particularly for isolators and restricted access barriers (RABs).
• Manage the material transfer chamber, ensuring components are cleaned and transferred into the filler.
• Work with experts to develop and document protocols for various validation activities.
• Collaborate closely with engineers, automation specialists, and the MSAT team to align priorities and ensure smooth operations.

Qualifications of the Validation Engineer:

• Minimum 5 years of direct validation experience, with 10 years preferred for process engineering support.
• Strong understanding of filling equipment, APS, smoke studies, cycle development, and cleaning validation.
• Excellent communication skills, with the ability to engage and motivate team members.
• Self-starter who can drive projects forward and ensure timely completion.
• Willingness to travel as required for equipment validation and material transfer.

Compensation of the Validation Engineer:
Pay Range: $60-$80/hr depending on experience
Benefits: Health, dental, vision, PTO, and sick leave as required by law. Also, you’ll be part of a team working on what will be the largest CDMO of its kind.
Application Details: This job opens for applications on 4/18. Applications for this job will be accepted for at least 30 days from the posting date.
Keywords: validation, engineer, APS, smoke studies, cycle development, cleaning validation, material transfer, QC, biologics, CDMO, pharmaceutical, filling, fill line, chemical engineering

• Conduct Aseptic Process Simulation (APS) by filling media to promote growth, incubating containers, and making interventions to identify contamination risks. Capture all interventions and develop protocols to ensure equipment quality.
• Perform smoke studies to ensure laminar airflow and identify any turbulence.
• Collaborate with vendors on vaporized hydrogen peroxide (VHP) cycle development to verify kill rates using biological and chemical indicators. Validate the cycle and place indicators as needed.
• Oversee cleaning validation for single-use and indirect parts, ensuring sufficient silicone removal and preventing contamination transfer.
• Conduct media fills, smoke studies, decontamination, and cycle validation, particularly for isolators and restricted access barriers (RABs).
• Manage the material transfer chamber, ensuring components are cleaned and transferred into the filler.
• Work with experts to develop and document protocols for various validation activities.
• Collaborate closely with engineers, automation specialists, and the MSAT team to align priorities and ensure smooth operations