Country United States
City Irvine, California
Functional Area Operations
Job Group Engineering
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
The Process Expert is responsible for managing production instrumentation, optimization of existing processes, and development of new processes. This scope includes initiation, scheduling, monitoring, and closure according to GMP, safety, and environmental requirements. The successful candidate should set a strong example for: determination to meet ambitious goals/timelines, customer service attitude toward colleagues, and motivation to help cancer patients.
Primary Responsibilities:
• Own or support production documentation, including Master Batch Records, SOPs, risk assessments, protocols, reports, and other documentation as needed.
• Technical writing/reviewing to support production operations including, SOPs, qualification protocols, and batch records.
• Collect data for process qualification and implementation.
• Owning or supporting investigations related to material transfer, API production, drug substance formulation, drug product filling, inspection, and packaging.
• Support process optimization, development of new processes, and introduction of new technologies.
• Lead equipment qualifications and improvement projects. Support the execution of process validations.
• Responsible for all production instrumentation: IQ/OQ/PQ, owning equipment protocols/SOPs, coordinating PMs/calibration/requalification, maintaining inventory of spare parts, coordinating repairs, making minor repairs in-house.
• Provide guidance, support, training, and knowledge to Production team.
Expanded Responsibilities:
- Take a leadership role in managing multiple projects.
- Work with other employees on the Production and Quality teams.
- Coordinate internal resources and third parties.
- Supervise work of contractors.
- Create/maintain comprehensive project documentation. Work with Quality Unit to ensure readiness for inspections.
- Ensure that all activities are in compliance with GMP, FDA/NRC/EPA regulations, and Orano Med Policies.
- Capable of being trained in production of API and aseptic final drug product. Willing to fill in on production team.
- Support cross-functional teams to address all site-related activities, such as urgent events that regulations, and Orano Med Policies.
- Capable of being trained in production of API and aseptic final drug product. Willing to fill in on production team.
- Support cross-functional teams to address all site-related activities, such as urgent events that require technical expertise.
Your profile
Qualifications:
• Bachelor's degree in Engineering, Pharmacy, Pharmaceutical Sciences, Biology, or Chemistry.
• 3 years experience in a process support or development role in GMP manufacturing and/or QA/QC.
• Previous experience with qualifying instruments and processes in a new manufacturing facility.
• Understanding of manufacturing processes in pharma, GMP, quality and regulatory aspects.
• Proficient in technical writing.
• At ease with following detailed SOPs and completing extensive detailed documentation (e.g., batch records) and patiently revising documentation following QA review.
• Attendance of production up to 50%. Typical production shift will be approximately: 3:00 PM to 12:00 AM. Ability to work overtime, weekends, and off shifts, as needed.
• Knowledgeable on PPE: safety glasses/goggles, hair net, mask, gloves, appropriate shoes, and scrubs under a lab coat or Tyvek suit.
• Ability to safely lift 50 pounds.
Target Range: $90,000 - 100,000
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