Filling/Manufacturing Associate I

Title: Filling/Manufacturing Associate I
Full Time
Location: Pleasant Prairie, WI
Our Company
Nexus Pharmaceuticals, a US-based healthcare company, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor intensive, and more streamlined in practice. Nexus ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and delivers dependable life-saving treatment options when and where they're needed most.
Summary
Nexus Pharmaceuticals is hiring Filling/Manufacturing Associates at various position levels to work in the new aseptic manufacturing facility located in Pleasant Prairie, WI.
The Filling/Manufacturing Associate I will use proper aseptic technique while performing tasks in Grade C (ISO 8) areas to include:

• Bulk formulation of aqueous and non-aqueous based products, including suspensions and emulsions
• Vial filling operations with an automated line in an isolator environment
• Routine and non-routine aseptic interventions through isolator glove ports
• Unloading of autoclaves and management of sterilized components
• Performing cleaning operations for process equipment and the GMP ISO 8 areas

Responsibilities:

• Operate processing equipment in accordance with SOPs, in classified areas
• Actively participate in troubleshooting processes and equipment problems as well as assisting the supervisor in completing all necessary paperwork associated with investigations, deviations and remarks
• Use proper aseptic technique while performing tasks to set up filling line equipment including: Vial washer, depyrogenation tunnel, filling line, lyophilizer loading system, capper and tray loader
• Perform aseptic manipulations via glove ports in the filling isolator (ISO 5) to include: set up of filling line, routine aseptic interventions, non-routine aseptic interventions (filler setup, needle changeout), operating filling and auto loading equipment using automated control systems; perform automatic weight checks; assist with and performs all interventions without compromising aseptic environment
• Break down of filling line equipment for changeovers, clean and sanitize isolator, set up isolator for next fill and oversee the decontamination of the isolator via VHP cycle operation
• Troubleshoot process equipment and interact with maintenance personnel
• Demonstrate proficiency as outlined in training requirements for equipment systems and position
• Responsible for loading and unloading materials, labeling according to SOPs, assembling valves, connectors, and other equipment and tools using aseptic technique
• Recognize and report deviations or potential issues immediately to the management team
• Assist in the packaging department running equipment and performing manual packing
• Communicate and report status of equipment maintenance related issues to the area supervisor/manager, and assist with actions necessary to resolve issues
• Perform all job responsibilities in compliance with applicable EHS, GMP, SOP regulations, guidelines, and policies
• Monitor, implement, and maintain a safe work environment through application of safety rules/regulations, training, observations/response
• Other duties as assigned

Requirements
Desired Characteristics:

• The capability to maintain attention to detail and quality and a high level of integrity and confidentiality, while completing multiple or repetitive tasks and meeting timelines and deadlines
• Ability to read, understand, follow, and comply with technical and written documents (SOPs)
• Ability to perform calculations using simple mathematical formulas. The ability to measure volume and weight
• Must be able to follow detailed processing instructions as well as clearly and accurately documenting all necessary batch documentation
• Basic computer skills required
• Ability to establish and maintain working relationships cross functionally including production, Quality Assurance, Quality Control, engineering, validation, and maintenance
• The ability to communicate effectively, both verbally and in writing, to all levels within the organization
• Position may require employees to work in a 24/7 rotational schedule. This schedule will include holidays, and weekends; over-time may be required. Work closely with shift team to achieve goals in a 24/7 cGMP Production Environment

Education or experience:

• High School Diploma required. Strong work history
• Basic mechanical aptitude
• Exposure to technical or manufacturing environments desired, however not required

Travel Requirements:

• 0-5% travel required for this role

Physical Requirements:

• Physical requirements include stooping, standing, climbing and lifting between 30 - 50 lbs.
• Ability to work while wearing appropriate PPE
• Ability to maintain gowning requirements

DISCLAIMER: The list under Role Responsibilities is not exhaustive, but is merely the most accurate lists for the current job. Management reserves the right to revise the job description and to require that other tasks be performed when the circumstances of the job change.
EEOC Statement: Nexus is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Nexus participates in E-Verify.