Sterility Assurance Technician

We are seeking a Sr. Process Technician - Sterility Assurance TS/MS to support aseptic

manufacturing operations within a pharmaceutical parenteral manufacturing environment. This

individual will serve as an extension of the Sterility Assurance team on the manufacturing floor,

partnering closely with Operations, Quality, and Environmental Monitoring teams to ensure

aseptic practices, contamination control, and bioburden control standards are maintained

throughout production activities.

This is a highly floor-facing role that requires strong aseptic processing knowledge, hands-on

cleanroom experience, and the ability to coach and guide manufacturing operators on proper

GMP and aseptic behaviors. The ideal candidate will have direct experience supporting filling,

formulation, isolator operations, and aseptic interventions in a classified manufacturing

environment.

Key Responsibilities

• Serve as a Sterility Assurance resource within aseptic manufacturing operations

• Provide real-time support on the manufacturing floor during production activities

• Coach, mentor, and reinforce proper aseptic behaviors with manufacturing operators

• Perform routine audits of aseptic practices, cleanroom behaviors, and GMP compliance

• Identify risks to aseptic conditions and support remediation activities

• Partner with Operations and Environmental Monitoring teams to maintain contamination

control standards

• Support filling, formulation, isolator operations, and aseptic interventions

• Assist with troubleshooting and responding to unplanned manufacturing events

• Support deviation investigations related to sterility assurance, contamination control, and

aseptic processes

• Participate in root cause analysis and corrective/preventative actions (CAPAs)

• Conduct procedural compliance reviews and identify improvement opportunities

• Support environmental monitoring and microbiological control initiatives

• Assist with qualification and validation activities related to sterility assurance

• Support smoke studies and other aseptic qualification activities* Review and maintain GMP documentation in alignment with regulatory expectations

• Analyze manufacturing data and provide recommendations for compliant solutions

• Act as a technical resource for sterility assurance questions and concerns

Do you have experience in Sterile field situational awareness?, * Minimum 2+ years of experience supporting pharmaceutical cGMP manufacturing

• Experience within parenteral drug product manufacturing

• Strong understanding of aseptic processing principles

• Hands-on experience working in classified cleanroom manufacturing environments

• Experience supporting one or more of the following:

o Filling operations

o Formulation activities

o Isolator operations

o Aseptic manufacturing processes

• Knowledge of GMP documentation practices and regulatory compliance

• Experience identifying and correcting aseptic behaviors or compliance concerns

• Ability to work directly with manufacturing operators and cross-functional teams

• Comfortable being highly visible on the production floor

• Strong communication skills with the ability to coach and influence others

Preferred Qualifications

• Environmental Monitoring (EM) experience

• Microbiology background

• Bioburden control experience

• Equipment qualification experience

• Validation experience

• Smoke study experience

• Deviation investigation support

• CAPA and change control experience

• Experience with quality systems such as:

o TrackWise

o Kneat

o Other QMS platforms

Candidates should be comfortable:

• Working in cleanroom environments

• Coaching operators on GMP behaviors

• Addressing non-compliance professionally

• Supporting active manufacturing operations

• Collaborating with Operations, Quality, Validation, and Environmental Monitoring teams

Schedule Requirements* Night shift: 6:00 PM - 6:00 AM

• 2-2-3 rotating schedule

• Must be flexible to support:

o Production needs, * How many years of experience do you have in supporting pharmaceutical cGMP manufacturing?

• Do you have experience in aseptic processing?
• you have in supporting pharmaceutical cGMP manufacturing?

Ideal Answer: Minimum: 2 How many years of experience do you have in filling, formulation, and or/isolator operations?

(part of Eight Eleven Group) 4.04.0 out of 5 stars 59 Moore Drive, Durham, NC 27703 $28 - $30 an hour - Contract