Demo

Production Supervisor

BioSpace
Irvine, CA Full Time
POSTED ON 12/21/2025
AVAILABLE BEFORE 1/19/2026
Your Role

Coordination, management, and supervision of the production processes related to the operations of the area, in order to comply with the planned production schedule in accordance with the procedures and standards established by Siegfried and with the quality, safety, and productivity levels required both by Siegfried and the current legal regulations. Optimize the performance and cost of the department's human resources and machinery, as well as the processes within the section.

Responsibilities

Your Profile:

  • Responsible for ensuring compliance with Safety Standards in the area.
  • Implements the established production programs for the Production Unit (PU), guaranteeing the achievement of the planned production levels and optimizing the use of available production resources: labor, machinery, facilities, and materials, while ensuring product quality and optimal production costs.
  • Ensures compliance with applicable quality regulations for the section’s activities (GMPs, GDPs, ISO, etc.), taking responsibility for the quality of the products produced.
  • Manages available resources to ensure fulfillment of the production plan and implements actions to address any deviations that may arise, whether in productivity or quality.
  • Proposes and implements improvements to work methods from both a process optimization and quality perspective, and carries out or collaborates in the execution of tests that may contribute to continuous improvement.
  • Oversees compliance with the established production plan by coordinating with Senior Operators to achieve it, and reports to the PU Head on any deviations that may occur, whether related to productivity or quality.
  • Analyzes data on performance, waste, and process deviations from standards, and proposes measures to reduce them.
  • Provides timely reports to the PU Head on anything that might impact the achievement of both short-term and medium- to long-term objectives.
  • Prepares SOPs (Standard Operating Procedures), forms, and other documents related to the section. Is responsible for managing any necessary updates to ensure they are always current and properly communicated throughout the team. May also, if necessary, make changes to MBRs (Master Batch Records) to comply with current regulations.
  • Investigates incidents and non-conformities in order to identify root causes and establish appropriate preventive and corrective actions.
  • Oversees proper completion and updating of documentation, as well as the correct execution of process requirements by Senior Operators and Operators, in accordance with current documentation (e.g., MBRs, SOPs).
  • Collects documentation for each completed work order, reviews it for quality and performance compliance, and approves it once assured of proper adherence to GDPs, GMPs, and performance standards.
  • Collects documentation for each completed work order, reviews it for quality and performance requirements, and approves it once proper compliance with GDPs, GMPs, and performance standards is confirmed.
  • Monitors the training, skills, and attitudes of personnel under their supervision and assigns staff to processes for which they are properly qualified, promoting their development.
  • Collects and reports data provided by Operators regarding absences, tardiness, leaves, and potential accidents involving section staff, initiating investigations if such incidents occur.
  • Manages staff vacations to ensure fulfillment of the schedule while enabling proper time off.
  • Tracks the availability of all necessary materials for the area’s operations (MBRs, materials, etc.), verifying their suitability and quality.
  • Ensures proper supervision of line and area cleanings, meeting the deadlines and frequencies established in current procedures.
  • Collaborates with the PU Head, Facilitator, and Technicians from other areas and departments in shared tasks aimed at achieving departmental objectives.
  • Defines area staff objectives and monitors progress to ensure effective performance and proper area operations.
  • When applicable, monitors and supervises aseptic behaviors of operators within the aseptic area.
  • Coordinates with managers from other sections and departments at Siegfried for any processes requiring their involvement (e.g., projects, meetings, etc.).
  • Promotes a work environment that fosters dedication and professional development among the team under their supervision.
  • Whenever necessary, performs tasks corresponding to the level of a Senior Operator.


Required Knowledge, Skills And Abilities

  • Minimum of 2 years as a Technician in manufacturing and/or packaging areas, preferably in processes related to the production of sterile products within the pharmaceutical industry.
  • Packaging machinery, process validations.
  • High level of responsibility.
  • Ability to lead a team.
  • Strong teamwork skills.
  • Negotiation and decision-making skills.
  • Strong organizational, planning, and adaptability skills.


Required Education And Experience

  • Degree in Chemistry or Engineering
  • Experienced in working in GMP, FDA, ISO environments and aseptic areas.
  • Strong computer skills


Your Benefits

  • Medical, Dental, Vision
  • Flexible Spending & HSA Options
  • Life Insurance, Short & Long Term Disability
  • Pet Insurance
  • 401K


Siegfried is a 24-hour cGMP Manufacturing Facility, the current opening is for 2nd Shift (2:00 PM - 10:30 PM)

Salary.com Estimation for Production Supervisor in Irvine, CA
$68,124 to $88,316
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