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  Maintain certification for aseptic gowning and demonstrate the ability to perform all duties using proper aseptic technique.
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  Perform equipment preparation, including CIP (Clean-in-Place) and SIP (Steam-in-Place) operations, to prepare equipment for use.
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  Execute manufacturing instructions to perform compounding, filtration, formulation, and fill activities for aseptic and terminally sterilized products in accordance with SOPs.
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  Strongly adhere to verbal instructions and written procedures when operating production equipment and performing processing steps.
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  Accurately complete all required production documentation, ensuring forms, logbooks, form preparations, and batch records are complete, reviewed, and meet Good Documentation Practices (GDP).
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  Perform room sanitization activities to maintain controlled environment conditions.
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  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.
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  Execute routine and critical operations, as well as commissioning and validation activities, as assigned.
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  Support the engineering, warehouse, and facilities departments to build cross-functional skills, as required.
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  Revise and author Standard Operating Procedures (SOPs) and Batch Records.
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  Assist with the formulation and validation of new processes in partnership with the tech transfer group.
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  Ensure sanitization and sterilization practices are followed, including building, cleaning, sanitizing, and sterilizing equipment and components to support production operations.
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  Maintain responsibility for floor inventory and communicate schedule changes to the Supervisor, as needed.
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  Perform additional duties as assigned.

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  Lead teams to complete manufacturing activities.
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  Initiate deviations or investigations of varying complexity, working with cross-functional departments to identify root cause and implement appropriate corrective actions.
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  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.
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  Assist with training of Manufacturing Associate I’s and II’s.

Requirements

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  Bachelor’s Degree in a Life Sciences or Liberal Arts field, or equivalent experience.
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  5-7 years of professional manufacturing experience in an aseptic, FDA-regulated pharmaceutical facility.
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  Ability to manage floor activities in the absence of the Supervisor.
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  Experience in reviewing and creating controlled documents.
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  Experience with sterile injectable drug products and well versed in aseptic technique.
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  Familiarity with formulation, filling, primary packaging, and aseptic processing.
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  Willingness to work extended shifts and a variable schedule when required.
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  Skilled in MS Office/Excel tools.
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  Excellent communication skills, verbal and written.
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  Self-motivatedl with the ability to complete multiple floor activities in an effective and compliant manner.
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  Strong attention to detail, organizational skills, and commitment to quality.
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  Proven ability to plan and prioritize complex activities.
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  Strong analytical skills and mechanical aptitude to identify risks and prepare balanced decisions.
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  Positive attitude and strong interpersonal skills.

Benefits

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  Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
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  Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
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  401(k) and 401(k) matching
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  PTO, Sick Time, and Paid Holidays
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  Education Assistance
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  Pet Insurance
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  Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more)
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  Financial Perks and Discounts