Manufacturing Associate I

This is a W2 temporary position through January 29, 2027 with potential FTE extension. Shifts are expected to begin as Friday–Sunday, however, candidates must be able to commit to variable shifts including weekdays, evenings, weekend-focused schedules, or 7-day rotating schedule for the duration of the position.

About the Role

This position is responsible for performing a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set and current GMP/ISO requirement and standards as defined in FDA and EU applicable Regulations. With general supervision the individual will perform routine and critical manufacturing operations, including but not limited to work functions in aseptic and non-aseptic filling, equipment prep, cleaning dissolution and formulation activities. The individual may provide support in other departments within the company, including but not limited to, engineering, warehouse and facilities.

Responsibilities

• Maintain certification for aseptic gowning and demonstrate the ability to perform all duties using proper aseptic technique.
• Perform equipment preparation, including CIP (Clean-in-Place) and SIP (Steam-in-Place) operations, to prepare equipment for use.
• Execute manufacturing instructions to perform compounding, filtration, formulation, and fill activities for aseptic and terminally sterilized products in accordance with SOPs.
• Strongly adhere to verbal instructions and written procedures when operating production equipment and performing processing steps.
• Accurately complete all required production documentation, ensuring forms, logbooks, form preparations, and batch records are complete, reviewed, and meet Good Documentation Practices (GDP).
• Perform room sanitization activities to maintain controlled environment conditions.
• Identify, escalate, and document events that deviate from normal operations; participate in investigations as needed; assist in introducing new manufacturing schemes into the GMP manufacturing facility.
• Execute routine and critical operations, as well as commissioning and validation activities, as assigned.
• Support the engineering, warehouse, and facilities departments to build cross-functional skills, as required.
• Perform additional duties as assigned.

Requirements

• High School Diploma with 1-2 years of work experience in mechanically based or similar role.
• 1-2 years of professional manufacturing experience in an FDA Regulated Pharmaceutical facility preferred.
• Experience reviewing and creating controlled documents preferred.
• Experience with sterile injectable drugs preferred.
• Familiarity with formulation, filling, primary packaging, and aseptic processing preferred.
• Strong knowledge of aseptic techniques is preferred.
• Willingness to work extended shifts and a variable schedule when required.
• Excellent communication skills, verbal and written.
• Experience with MS Office/Excel tools.
• Self-motivated with the ability to complete multiple floor activities in an effective and compliant manner.
• Strong attention to detail, organizational skills, and commitment to quality.
• Proven ability to plan and prioritize complex activities.
• Strong analytical skills and mechanical aptitude to identify risks and prepare balanced decisions.
• Positive attitude and strong interpersonal skills.

Benefits

• This position is eligible for overtime, which may be required based on production demands.
• W2 Temp roles include our Medical and Sick Time benefits.