Country United States
City Irvine, California
Functional Area Operations
Job Group Production
Employment Type Permanent Contract
Working time Full-time
At its locations around the world, Siegfried offers employees exciting career opportunities in international settings. We cultivate multidisciplinary cooperation and encourage our staff to actively shape and influence their careers. This approach, coupled with our dynamic working environment, make Siegfried an attractive employer.
Your role
Scope and Purpose of Position
As a Production Shift Leader, you will be responsible for the coordination, management, and supervision of the production processes related to the operations of the area, 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 resources (people and machinery), as well as the processes within the section.
Responsibilities
- 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.
- Oversee 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. 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 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.
- 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 potential accidents involving section staff, initiating investigations into if such incidents occur.
- Manages staff PTO and other absences 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.
- Collaborate 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, perform tasks corresponding to the level of a Senior Operator.
Your profile
Required Knowledge, Skills and Abilities
- Minimum of 5-7 years as an Operator in manufacturing and/or packaging areas, preferably in processes related to the production of sterile products within the pharmaceutical industry.
- Aseptic Filling 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 or equivalent
- Experienced in working in GMP, FDA, ISO environments and aseptic areas.
- Strong computer skills
As Siegfried is a 24-hour cGMP Manufacturing Facility, there are openings for the Production Shift Leader on multiple shifts. Please indicate when apply which shift(s) you are available to work: 2nd Shift (2:00 PM - 10:30 PM); 3rd Shift (10:00 PM - 6:30 AM)
Target Salary Range: $100,000 - 115,000/year
Working at Siegfried
Siegfried's work environment is dynamic and international. With a highly professional and motivated team, the company operates in a future-oriented business field. Siegfried possesses a unique culture that leverages cultural differences to create a competitive advantage. Siegfried places highest priority on providing a flexible, diverse and discrimination-free working environment in which employees can develop personally and professionally, advance innovation and deliver superior performance. We strive to provide a work environment where employees can take on challenging jobs and associated responsibilities that best serve their personal and technical development and can benefit from the success of our company. The company regulations in respect of compensation and career development opportunities apply to all Siegfried sites. Additional conditions of employment are governed by location-specific circumstances, legislation and customs.
Who we are
In the Midst of People’s Lives – Across the Globe
The Siegfried Group is one of the world’s leading Custom Development and Manufacturing Organizations (CDMOs) developing and producing active pharmaceutical ingredients (API), intermediates and finished dosage forms. As our core competence, we successfully integrate chemical and pharmaceutical capabilities into a single business model.
The Siegfried name stands for highest quality, efficiency, flexibility and safety. Present in Europe, Asia and North America, we serve a broad global customer base from major international pharmaceutical companies down to small biologic-pharmaceutical organizations. For them we develop and produce product innovations on a large scale to finished products. We integrate our offer seamlessly into the customers’ value chain. Our comprehensive services range from early-stage Research & Development services such as synthesis, scale-up, formulation development, stability studies and method development all the way through to manufacturing services, ranging from preclinical R&D material for clinical trial purposes to commercial production.
We are able to produce about 200 of the approximately 1500 registered drug substances used in medicine. Moreover, we produce 20 percent of global demand for caffeine. Consequently, nearly 1 billion individuals come into contact with Siegfried products.
What we do in Irvine
Irvine is one of Siegfried’s sterile drug product manufacturing sites, providing contract development and manufacturing services (CDMO) specializing in difficult to manufacture pharmaceuticals, ophthalmics, and drug delivery devices.
Main activities
- Provides cGMP sterile drug product fill finish of biologics, suspensions, emulsions, ointments, and gels
- All fully cGMP and SHE compliant
Features
- Commercial Products: 5 automated filling lines, Commercial manufacturing, Batch sizes up to 150 K units, Fill Volumes 0.5 ml – 100 ml
- Semi-automated and automated visual inspection
- Automated packaging with digital data visual verification
- Stability study services
- Drug delivery
- Laboratory services
- Clinical Products small lot capability (semi-automated filling, batch sizes up to 5 K units)
- Clinical manufacturing (batch sizes less than 5 K units)
Strategic importance
- CDMO for innovative and difficult-to-manufacture products from clinical to commercial NDA and ANDA products
- Provides contract sterile drug product manufacturing and laboratory services to the pharmaceutical and biotechnology industries