Aseptic Process Engineer

About the position

These resources will be responsible for activities relating to media fills for a site modernization project. Support consists of observing Manufacturing Operators and EM analysts' interventions within the Grade A space and understanding the basics of aseptic processing. Documentation of the observed interventions during the media fill and keeping up with accountability of media units will be main responsibilities. Responsibilities might change as needed depending on business. Consultants will be trained on our SOPs and other procedures as well as being aseptically trained. Activities are expected to be performed on a 24hr basis so night shift and weekend work will be required to support the media fills amongst all team members. Will also provide oversight for the completion of EMPQ activities and support for EM sampling as needed. Responsibilities might change as needed.

Responsibilities

• Observe Manufacturing Operators and EM analysts' interventions within the Grade A space.
• Understand the basics of aseptic processing.
• Document observed interventions during the media fill.
• Keep up with accountability of media units.
• Provide oversight for the completion of EMPQ activities.
• Support for EM sampling as needed.

Requirements

• Experience in aseptic processing.
• Knowledge of sterile manufacturing.
• Familiarity with GMP (Good Manufacturing Practices).
• Background in microbiology.
• Experience in environmental monitoring.
• Knowledge of bioprocessing.
• Experience in validation.
• Experience in aseptic process simulation.

Nice-to-haves

• GMP pharmaceutical manufacturing experience.
• Experience in aseptic process simulation.

Benefits

• Medical, dental & vision insurance.
• Critical Illness, Accident, and Hospital insurance.
• 401(k) Retirement Plan with pre-tax and Roth post-tax contributions.
• Voluntary Life & AD&D insurance for the employee and dependents.
• Short and long-term disability insurance.
• Health Spending Account (HSA).
• Transportation benefits.
• Employee Assistance Program.
• Time Off/Leave (PTO, Vacation or Sick Leave).