The Siegfried Group is a global life science company with a network of 12 sites across Europe, the USA, and Asia. Siegfried offers contract development and manufacturing of active pharmaceutical ingredients, intermediates, and drug products. Siegfried has sales of 1.3 billion USD and employs over 3,600 people. Siegfried Holding AG is listed on the SIX Swiss Exchange (SIX: SFZN).
Our site in Irvine has been part of Siegfried since 2012 and counts around 150 employees. It is our sterile drug product manufacturing site in the US and provides cGMP sterile drug product fill and finish of biologics, suspensions, emulsions, ointments, and gels.
To support our Technology Transfer group, we are currently looking to fill the position of Validation Associate II.
If you are looking to develop yourself within a dynamic team, this might just be the right opportunity for you. This is an entry level job.
Your role

• Write validation protocols to support the validation of new and existing equipment and processes
• Operate validation equipment as needed and execute protocol for validation
• Assist in training personnel as required for execution of validation protocols and/or deviation mitigation
• Communicate with relevant departments for completion of validation related testing, qualification, or process improvement
• Investigate validation related deviation or systemic problems to identify root cause and effective corrective and preventive actions
• Review sterilization chart and release production sterilization cycle
• Assist in the review and modification of different procedures and documents as part of continuous process improvements
• Create relevant validation documentation to support customer submission to regulatory bodies

Your profile

• Bachelor's degree in Biochemistry, Chemistry, Biology or closely related discipline
• New graduate, 1 years of experience in Validation or in a Manufacturing environment will be considered a plus
• Knowledge and training in GMP/GLP/ISO guidelines
• Strong attention to detail and eagerness to grow and learn
• Good oral and written communication skills

Pay range: $ 28-31 per hour
Working at Siegfried

• Medical, Dental, Vision
• Employer Sponsored Life & AD&D, Long & Short-Term Disability Insurance Plans
• Voluntary Life & AD&D, Accident and Critical Care Insurance Plans
• 401K Retirement Program with Matching
• Generous Paid Time Off, Sick Time and Paid Company Holidays

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