Genentech ยท 23 hours ago
Environmental/Sterility Quality Assurance (EQA) Specialist
Hillsboro, OR
Full-time
Onsite
Mid, Senior Level
$94K/yr - $175K/yr
5+ years expGenentech is a leader in cell and gene therapy manufacturing located in Hillsboro, Oregon. They are seeking an Environmental/Sterility Quality Assurance (EQA) Specialist to ensure the highest standards of contamination control, sterility assurance, and regulatory compliance for advanced therapeutic medicinal products.
BiotechnologyLife ScienceManufacturing
Responsibilities
Support the implementation and execution of site-level Contamination Control Strategy (CCS) programs, such as environmental monitoring, aseptic processes, utility systems, and HVAC qualifications
Provide technical assessment, oversight, and approval of CCS and sterility assurance-related systems, ensuring alignment with cGMP, ATMP GMPs, USP, EP, and JP standards
Collaborate with manufacturing, quality, and facility teams to develop unified strategies for contamination control and sterility assurance while ensuring compliance with regulatory requirements
Offer Quality oversight for routine environmental monitoring and aseptic process simulations, ensuring programs meet regulatory and operational standards
Act as a key resource for regulatory submissions and facilitate interactions with regulatory agencies by advancing site sterility assurance programs
Drive continuous improvement initiatives by recommending enhancements to contamination controls, personnel training, and operational processes
Serve as a subject matter expert (SME) in sterility assurance principles and practices, providing guidance to cross-functional teams and training them as needed
Qualification
Required
You possess a Bachelor's degree in life sciences or related scientific discipline
You possess 5 or more years of experience in a regulated industry (e.g., pharma/biopharmaceutical or medical device) along with at least 4 years in Quality, Compliance, Regulatory, and/or Validation
You have a strong understanding of quality assurance concepts, including cGMP, ATMPs, contamination control principles, sterility assurance programs, and ATMP-specific standards
You have large molecule and/or ATMP drug product manufacturing and expertise in risk-based approaches to compliance and sterility assurance processes
You have a proven ability to collaborate effectively in a matrixed environment and manage stakeholders across diverse teams
You are a skilled communicator with the ability to influence, coach, and partner with multidisciplinary stakeholders to achieve organizational goals
Preferred
You possess experience with investigational medicinal products, product development, phase-appropriate approaches, and multiple manufacturing technologies and product lifecycles
Benefits
A discretionary annual bonus may be available based on individual and Company performance.
Company
Genentech
Genentech is a biotechnology research company that specializes in genetic testing and personalized medicines.
10001+ employees
H1B Sponsorship
Genentech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (167)
2024 (148)
2023 (150)
2022 (178)
2021 (121)
2020 (158)
Funding
Current Stage
Public CompanyTotal Funding
unknown2009-03-26Acquired
1999-07-20IPO
1976-01-01Series Unknown
Leadership Team
Ashley Magargee
Chief Executive Officer
Michael Laird
Vice President, Global MSAT Drug Substance Biologics Technology and Commercial Products Support
Recent News
2026-01-07
MarketScreener
2026-01-06
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