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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 and safety policies while ensuring high-quality documentation and aseptic practices.
Highest-signal resume keywords
Aseptic Fill OperationsFDA Regulations ComplianceProcess Equipment OperationDocumentation MaintenanceClean-Room Manufacturing
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 Fill TechniquesFreeze-Drying ProcessDocumentation MaintenanceSanitization ProceduresTouchscreen Operator Interface TerminalsLifting and Carrying 45 lbsPrecise Hand MovementsComputer LiteracyMS Office Proficiency
Soft Skills
Attention to DetailStrong Work EthicInterpersonal SkillsProactive AttitudeTime Management
Certifications & Qualifications
High School Diploma or GEDAssociate’s Degree or Applicable Certification
Industry Keywords
Biologics ProcessingPlasma-Derived PharmaceuticalsClean-Room EnvironmentPersonal Protective EquipmentSafety Policies
About the role
Key responsibilities & impact- Set up, operate, and clean process equipment in a biologics processing environment for plasma-derived pharmaceuticals
- Follow procedures and practices according to FDA regulations
- Maintain strong documentation according to FDA regulations
- Adhere to departmental and corporate safety policies
- Clean facilities and equipment
- 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 be trained in the freeze-drying (lyophilization) process
- Utilize touchscreen Operator Interface Terminals (OIT)
- Work in a sanitized clean-room manufacturing environment
- Perform a wide range of complex manufacturing tasks
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 the ability to exercise good judgment
- Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines
- Strong interpersonal skills with the 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 to accommodate 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 standing, walking, bending, twisting, climbing, crawling, squatting, and at heights
- Ability to use required personal protective equipment
- Hearing acuity essential
- Color perception/discrimination, depth perception, and far vision correctable in one eye to 20/30 and the other eye to 20/100
- Ability to perform precise, coordinated hand and finger movements
- Ability to communicate and understand spoken and written information
- Ability to adhere to a work schedule to meet production standards
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
- Opportunities for professional growth and career progression
- Family-like culture