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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in operating and maintaining process equipment in a biologics processing environment, with a strong focus on adhering to FDA regulations and maintaining documentation. Capable of performing aseptic fills and ensuring cleanliness in both aseptic and non-aseptic areas.
Highest-signal resume keywords
FDA Regulations ComplianceAseptic Fill ExperienceProcess Equipment OperationDocumentation PracticesTeam Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Process Equipment OperationAseptic FillingCleaning and SanitizingDocumentation PracticesFreeze-Drying PreparationProtein Product PackagingTouchscreen Operator Interface TerminalsManufacturing Equipment OperationForklift OperationComputer Literacy
Soft Skills
Attention to DetailTask PrioritizationTeamworkCommunication SkillsFlexibility
Tools & Technologies
Touchscreen Operator Interface TerminalsMS Office Suite
Certifications & Qualifications
High School Diploma or GEDAssociate’s Degree or Applicable Certification
Industry Keywords
Biologics ProcessingPlasma-Derived PharmaceuticalsClean-Room ManufacturingFDA-Regulated ProceduresLyophilization
About the role
Key responsibilities & impact- Set up, operate, and clean process equipment in a biologics processing environment for plasma-derived pharmaceuticals
- Perform equipment and facility cleaning
- Clean and sanitize aseptic and non-aseptic processing areas
- Prepare and sterilize filling and freeze-drying components, including vials, stoppers, and filling assemblies
- Perform aseptic fills
- Separate, purify, fill, inspect, and package protein products
- Follow FDA-regulated procedures and practices
- Maintain required documentation according to FDA regulations
- Follow departmental and corporate safety policies
- Use touchscreen Operator Interface Terminals (OIT)
- May receive training in the freeze-drying (lyophilization) process
- Adhere to production schedules and standards in a clean-room manufacturing environment
Requirements
What you’ll need- High school diploma or GED required
- Associate’s degree, applicable certification and/or military veterans preferred
- Experience operating or working around manufacturing equipment, hand tools, moving machinery, forklifts, tractors and power equipment
- Strict adherence to FDA regulations and procedures
- Strong documentation practices according to FDA regulations
- Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
- Must be able to read, write, and speak English
- Flexibility to work varying shifts in a 24-hour, 7-day plant operation
- Strong attention to detail
- Ability to prioritize and manage multiple tasks to meet deadlines
- Ability to work in a team environment
- Ability to lift and carry 45 lbs. for up to 6–8 hours per day, with a maximum lift of 75 lbs.
- Ability to work standing, walking, bending, twisting, climbing, kneeling, crawling, squatting, and at heights
- Ability to use required personal protective equipment
- Hearing acuity, color perception/discrimination, depth perception, and correctable vision meeting specified standards
- Ability to communicate and understand spoken and written information
Benefits
Comp & perks- Up to 5% company bonus pool
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- PTO
- Paid holidays
- Up to 5% 401(K) match
- Tuition reimbursement
- Professional growth and career progression opportunities