Manufacturing Associate I - Fill Finish - 2nd Shift
About The Position
As a Manufacturing Associate I, Fill Finish (2nd Shift), you’ll play a hands‑on role in producing sterile drug products that patients and families depend on. You'll support fill‑finish operations by operating equipment, preparing materials, completing cGMP documentation, and maintaining a clean, compliant production environment. This role is ideal for someone who takes pride in precision, follows procedures with care, and enjoys being part of a collaborative manufacturing team where quality and safety come first. The Manufacturing Associate I, Fill Finish (2nd shift) provides process support for the production of drug products under strict adherence to cGMP, OSHA, and United Therapeutics policies and regulations in the Silver Spring, Maryland facility. Assist with operating process equipment under strict adherence to cGMP, OSHA, and United Therapeutics policies and regulations ensuring that the production areas and all equipment are clean and in orderly operating condition Utilize understanding of equipment to perform basic steps necessary to manufacture Monitor basic work processes, ensure components, materials and supplies are stocked prior to the start of the filling operations to assure compliance and completion of targets Provide necessary support for all production activities associated with production work Receive production raw materials Perform basic troubleshooting and assist with technical issues Complete general and triennial basic changes to SOPs and other manufacturing documents within limited scope Work on basic routine assignments per written procedures and batch records of basic scope with guidance from senior associates Complete all required documentation for proper traceability of a production lot Complete all cGMP training documentation within a pre-defined timeframe in order to ensure compliance Other duties as assigned
Requirements
- H.S. Diploma or General Education Degree (GED)
- 2+ years of experience in cGMP pharmaceutical manufacturing environment with a H.S. Diploma/GED or Associate's Degree or 0+ years of experience in cGMP pharmaceutical manufacturing environment with a Bachelor's Degree
- Ability to handle confidential company data, projects, and information
- Ability to see, discern, and distinguish colors ("trichromatic")
- Ability to interact with other departments effectively
- Ability to objectively, accurately, and thoroughly convey complex issues in writing
- Proficiency with Microsoft Office or equivalent
- Written and verbal communication skills
- Flexibility to work weekends in rare instances
Nice To Haves
- Associates Degree in a scientific discipline or related field or Bachelor’s Degree in a scientific discipline or related field
- 1+ years of experience in gowning procedures in a cGMP environment
- 1+ years of experience with sterile aseptic fill operations and equipment
- 1+ years of experience with manual / visual inspection of drug product containers
- 1+ years of experience with SAP or similar inventory management system
Responsibilities
- Assist with operating process equipment under strict adherence to cGMP, OSHA, and United Therapeutics policies and regulations ensuring that the production areas and all equipment are clean and in orderly operating condition
- Utilize understanding of equipment to perform basic steps necessary to manufacture
- Monitor basic work processes, ensure components, materials and supplies are stocked prior to the start of the filling operations to assure compliance and completion of targets
- Provide necessary support for all production activities associated with production work
- Receive production raw materials
- Perform basic troubleshooting and assist with technical issues
- Complete general and triennial basic changes to SOPs and other manufacturing documents within limited scope
- Work on basic routine assignments per written procedures and batch records of basic scope with guidance from senior associates
- Complete all required documentation for proper traceability of a production lot
- Complete all cGMP training documentation within a pre-defined timeframe in order to ensure compliance
- Other duties as assigned
Benefits
- Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
