Responsibilities:

• 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

Education and Experience:

• 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

Benefits Offered:

* 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

Pay range: $ 22-23 per hour

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

Job Type: Full-time

Pay: $22.00 - $23.00 per hour

Expected hours: No less than 40 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 1 year
• 2 years
• Under 1 year

Schedule:

• Monday to Friday
• Overtime

Work setting:

• In-person
• Manufacturing facility

Education:

• Bachelor's (Required)

Ability to Relocate:

• Irvine, CA 92618: Relocate before starting work (Required)

Work Location: In person