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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in operating equipment in a biologics processing environment, including aseptic filling and glass inspection, while adhering to safety and regulatory standards. Proficient in maintaining aseptic conditions and performing quality control tasks in compliance with industry regulations.
Highest-signal resume keywords
Aseptic Filling OperationsClass A/B Gowning QualificationSCADA System MonitoringRegulated Industry ExperienceMaterial Handling
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Aseptic TechniqueGlass InspectionSIP/PBC OperationsFilter Integrity TestingChemical Solution PreparationLyophilization ProcessHeat TreatmentPasteurizationComputer Control SystemsProduction Documentation
Soft Skills
Good Math AptitudeMechanical AptitudeCommunication Skills
Tools & Technologies
Motorized Transport EquipmentForkliftsLift Jacks
Certifications & Qualifications
Media Fill CertificationBioworks Certification Program
Industry Keywords
Biologics ProcessingPlasma-Derived PharmaceuticalsFDA RegulationsUSDA RegulationsNRC Compliance
About the role
Key responsibilities & impact- Set up and operate equipment in a biologics processing environment for plasma-derived pharmaceuticals
- Perform Class A/B gowning and facility cleaning of fill suites
- Operate glass inspection stations, rinser/tunnel, VAM and over sealer
- Load carts with vials or syringes
- Perform SIP/PBC operations and filter integrity testing
- Prepare chemical solutions for production use while following department safety rules
- Perform material handling and glass inspection activities
- Maintain facility housekeeping and sanitize production areas according to procedures
- Operate motorized transport equipment such as forklifts and lift jacks
- Complete real-time production documentation, BPRs, records and logs
- Monitor and operate computer control systems including SCADA and Andover
- Independently set up and operate fill equipment in an aseptic environment as Tech II
- Operate and monitor final-container lyophilization, heat treatment, pasteurization and cold box processes as applicable
- Prepare and label samples according to BPRs and non-routine requests
- Interpret and use company support systems independently
- Assist with Technician-level training and train less experienced Technicians on applicable computer systems
- Maintain aseptic gowning qualification and media fill certification
Requirements
What you’ll need- High School diploma OR GED required
- One year of regulated industry (FDA, USDA, NRC) experience OR graduation from an accredited college/university with an Associate’s or Bachelor’s degree OR completion of the Bioworks Certification Program preferred
- Tech II typically requires one year of experience as an Aseptic Filling Technician
- Good math and mechanical aptitude
- Ability to perform skills in an aseptic environment while maintaining product sterility
- Ability to lift up to 50 pounds
- Continuous standing, walking and some bending required
- Ability to work rotating shifts; off-shift and overtime work may be necessary
- Class A/B gowning qualification for facility cleaning of fill suites
- Maintain acceptable aseptic gowning qualification and media fill certification for Tech II
- Hearing acuity essential
- Color perception/discrimination required
- Far vision correctable in one eye to 20/30 and to 20/100 in the other eye
- Ability to communicate and understand spoken and written information
- Ability to perform precise coordinated finger, hand, and wrist movements
- Personal protective equipment required, including protective eyewear, chemical suits, safety shoes and/or rubber footwear, gloves, hearing protection and a respirator
Benefits
Comp & perks- Regular Full-Time employment
- Monday-Friday 2nd shift schedule (03:00PM - 11:30PM)
- Overtime opportunities may be available
