Manufacturing Associate III

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 requirements 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.

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 a 7-day rotating schedule for the duration of the position.

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.
• Revise and author Standard Operating Procedures (SOPs) and Batch Records.
• Assist with the formulation and validation of new processes in partnership with the tech transfer group.
• Ensure sanitization and sterilization practices are followed, including building, cleaning, sanitizing, and sterilizing equipment and components to support production operations.
• Maintain responsibility for floor inventory and communicate schedule changes to the Supervisor, as needed.
• Perform additional duties as assigned.

Additional Level III Responsibilities

• Lead teams to complete manufacturing activities.
• Initiate deviations or investigations of varying complexity, working with cross-functional departments to identify root cause and implement appropriate corrective actions.
• Assist the Supervisor, Engineer, and/or Facilities team with investigations; communicate quality issues or concerns to the Supervisor and QA; interact with cross-functional support teams such as Quality Assurance, Quality Control, Engineering, R&D, and Validation.
• Assist with training of Manufacturing Associate I's and II's.

Requirements

• Bachelor's Degree in a Life Sciences or Liberal Arts field, or equivalent experience.
• 5-7 years of professional manufacturing experience in an aseptic, FDA-regulated pharmaceutical facility.
• Ability to manage floor activities in the absence of the Supervisor.
• Experience in reviewing and creating controlled documents.
• Experience with sterile injectable drug products and well versed in aseptic technique.
• Familiarity with formulation, filling, primary packaging, and aseptic processing.
• Willingness to work extended shifts and a variable schedule when required.
• Skilled in MS Office/Excel tools.
• Excellent communication skills, verbal and written.
• 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.