Microbiologist III - 2nd Shift

Siegfried Ltd; Irvine (CA); On-site; USD 60,614 - 66,124; Full time

Benefits offered by this job

Medical, Dental, Vision

Flexible Spending & HSA Options

Life Insurance

Short & Long Term Disability

Pet Insurance

401K

Job summary

A leading global pharmaceutical company is seeking a Microbiologist III in Irvine, CA. This role involves overseeing microbiological testing, validating methods, and supporting aseptic operations. Candidates should have a Bachelor's degree in Microbiology and 8-10 years of relevant experience, demonstrating strong knowledge of microbiological principles and GMP compliance. The position offers opportunities for professional growth in a collaborative environment, alongside competitive compensation and comprehensive benefits.

Qualifications

• 8-10 years of experience in a pharmaceutical microbiology laboratory.
• Experience with microbiological method validation and aseptic operations support.
• GMP pharmaceutical experience required.

Responsibilities

• Independently perform microbiological testing and oversee associated methods.
• Execute qualifications and validations following regulatory standards.
• Serve as a technical SME for aseptic processing support.
• Analyze and trend environmental monitoring and microbiological data.
• Support regulatory inspections and audits in microbiology.

Skills

Advanced hands-on knowledge of pharmaceutical microbiological testing

Demonstrated ability to independently execute qualifications

Strong problem-solving skills

In-depth knowledge of GMP requirements

Excellent verbal and written communication skills

Ability to work effectively in cross-functional teams

Strong organizational skills

Proficient in MS Word and Excel

Education

Bachelor’s degree in Microbiology or closely related field

Job description

Microbiologist III page is loaded## Microbiologist IIIlocations: Irvine, CAtime type: Full timeposted on: Posted Yesterdayjob requisition id: R26\_128"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.**Your Role:**Scope and Purpose of Position The Microbiologist III is a senior individual contributor within the Microbiology laboratory and serves as a technical subject matter expert for microbiological testing, method qualification/validation, and aseptic manufacturing support. This role is responsible for independently executing microbiological studies and validations with minimal oversight and providing strong scientific and hands-on support to aseptic operations. The Microbiologist III is expected to be a highly capable bench microbiologist who can troubleshoot complex issues, support investigations, and work collaboratively across functions to ensure compliant, efficient, and robust microbiology programs in support of sterile drug product manufacturing.**Your Profile:**# ***Responsibilities***1. Independently perform and oversee microbiological testing of raw materials, in-process samples, utilities, and finished drug products, including but not limited to bioburden, sterility, endotoxins, microbial limits testing, growth promotion, BI enumeration, bacterial suspension preparation, sub-visible particulates, AET, and CCIT.2. Execute, author, and manage microbiological method qualifications and validations in accordance with USP, compendial requirements, internal SOPs, and regulatory expectations.3. Serve as a technical SME for aseptic processing support, including environmental monitoring (viable and non-viable), utilities monitoring (WFI, HPW, clean steam), and cleanroom behavior.4. Provide hands-on support for aseptic operations, media fills, personnel monitoring, aseptic gowning qualification, and on-the-floor microbiology support as needed.5. Analyze, trend, and interpret environmental monitoring and microbiological data; identify adverse trends and support investigations, impact assessments, and CAPAs.6. Support and author microbiology-related protocols, reports, deviations, investigations, and technical justifications.7. Participate in and support regulatory inspections, customer audits, and internal audits as a microbiology technical representative.8. Collaborate cross-functionally with QA, Manufacturing, MSAT, Engineering, Facilities, Validation, and external partners to support new product introductions, process changes, and continuous improvement initiatives.9. Ensure all microbiology laboratory activities are performed in compliance with GMP/GDP requirements and that all equipment used is properly qualified, calibrated, and maintained.10. Maintain accurate, contemporaneous documentation in laboratory notebooks, controlled forms, and electronic systems (e.g., LIMS).11. Support training, mentoring, and technical development of junior microbiology staff through knowledge sharing, technical leadership, and hands-on guidance. Acts as a go-to technical resource for complex microbiology and aseptic processing questions.12. Maintain laboratory areas in a clean, organized, and inspection-ready state; support laboratory operations activities as needed (media prep, autoclave use, chart changes, inventory support).13. Demonstrate a strong team-oriented mindset with a willingness to roll up sleeves and execute laboratory and manufacturing-support work as priorities require.14. Perform all other duties as assigned by the immediate supervisor.## ***Required Knowledge, Skills and Abilities**** Advanced hands-on knowledge of pharmaceutical microbiological testing and aseptic processing principles.* Demonstrated ability to independently execute microbiological method qualifications and validations without direct supervision.* Strong technical problem-solving skills and ability to troubleshoot complex microbiological and aseptic issues.* In-depth understanding of GMP requirements and relevant USP chapters applicable to microbiology and sterile manufacturing.* Excellent written and verbal communication skills, with the ability to clearly document and explain technical concepts.* Proven ability to work effectively in a cross-functional, fast-paced manufacturing environment.* Strong organizational skills with the ability to manage multiple priorities simultaneously.* Hands-on, proactive, and collaborative team player with a strong work ethic.* Proficient in standard computer applications (MS Word, Excel) and laboratory systems (e.g., LIMS); ability to quickly learn new systems.* Knowledge of laboratory safety requirements and aseptic gowning practices.## ## ***Required Education and Experience**** Bachelor’s degree in Microbiology or a closely related scientific discipline (advanced degree preferred).* Minimum of 8–10 years of experience in a pharmaceutical microbiology laboratory supporting sterile drug product manufacturing.* Demonstrated experience executing microbiological method validation/qualification and providing direct aseptic operations support.* GMP pharmaceutical experience required; experience supporting regulatory inspections strongly preferred.* Candidates with a non-Microbiology scientific degree and significant directly relevant microbiology experience will be considered.Target Pay Range: $44-48/hour*Individual compensation packages are based on various factors unique to each candidate, including skill set, experience, qualifications and other job-related reasons.***Your Benefits:*** Medical, Dental, Vision* Flexible Spending & HSA Options* Life Insurance, Short & Long Term Disability* Pet Insurance* 401KFounded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 13 sites across three continents. With a team of more than 3,800 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.### Our purpose drives us to be the strongest teamApplication Submission & Screening: Share your qualifications and enthusiasm through our application process. We review each submission to identify candidates whose skills best match the role. Initial Interview: We’ll explore your background, aspirations, and how you could contribute to our mission and culture. On-Site Interview: If possible, we invite you to meet us in person, connect with future colleagues, and get a feel for our workspace. Offer Stage: Congrats! If selected, you'll receive a detailed offer including compensation, benefits, and the exciting opportunities ahead. Onboarding: After you accept, we’ll guide you through a smooth, tailored onboarding experience to help you settle into your new role. Feedback & Improvement: Your feedback helps us continuously improve and enhance the candidate experience for others.