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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, adhering to FDA regulations while ensuring safety and quality standards. Proficient in aseptic techniques and capable of performing tasks related to the filling and packaging of protein products.
Highest-signal resume keywords
Aseptic Fill OperationsFDA Regulations ComplianceProcess Equipment OperationDocumentation AccuracyClean-Room Manufacturing Experience
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 TechniquesDocumentation CompletionProtein Product PackagingFreeze-Drying Process Knowledge
Soft Skills
Attention to DetailStrong Work EthicInterpersonal SkillsProactive AttitudeAbility to Manage Multiple Tasks
Tools & Technologies
Touchscreen Operator Interface TerminalsMS Office Suite
Certifications & Qualifications
High School DiplomaGEDAssociate's Degree (Preferred)Applicable Certification (Preferred)
Industry Keywords
Biologics ProcessingPlasma-Derived PharmaceuticalsSafety PoliciesClean-Room EnvironmentPersonal Protective Equipment
About the role
Key responsibilities & impact- Set up, operate, and clean process equipment in a biologics processing environment for plasma-derived pharmaceuticals
- Separate, purify, fill, inspect, and package protein products
- Follow procedures and practices according to FDA regulations
- Complete required documentation according to FDA regulations
- Adhere to departmental and corporate safety policies
- 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
- May train in the freeze-drying (lyophilization) process
- Utilize touchscreen Operator Interface Terminals (OIT)
Requirements
What you’ll need- High school diploma or GED required
- Associate’s degree, applicable certification and/or military veterans preferred
- Must be proactive, results oriented, and have strong attention to detail
- Self-starter with strong work ethic and ability to exercise good judgment
- Ability to prioritize and manage multiple tasks to meet targeted deadlines
- Strong interpersonal skills and ability to interact with personnel at all levels in a team environment
- Must be able to read, write, and speak English
- Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
- Must be flexible with working hours/shifts for 24-hour, 7-day plant operation
- 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 in clean-room manufacturing environments and tolerate exposure to biological fluids, chemicals, machinery, noise, dust/gas/fumes/steam, extreme temperatures, confined spaces, heights, and uneven ground
- Ability to use required personal protective equipment
- Required hearing acuity, color perception/discrimination, depth perception, and correctable far vision
- Ability to stand, walk, bend, twist, climb, crawl, squat, and perform frequent precise hand movements
- Ability to adhere to a work schedule meeting production standards
Benefits
Comp & perks- Up to 5% of the 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