MS&T Director, Validation Lead Steriles
Thermo Fisher ScientificSalary not specified
- Full Time
- Senior (5 to 8 years)
$60,000 – $90,000Compensation
Senior (5 to 8 years), Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceutical, BiotechnologyIndustries
Requirements
Candidates should possess a Bachelor’s degree in a scientific discipline, such as Microbiology, Biology, Chemistry, or Engineering, and have at least 8 years of experience in cleaning validation, with a strong understanding of cleaning validation principles, methodology, and life cycle associated practices. They should demonstrate expertise in executing cleaning studies for biological products, including experience with cleaning validation programs in multi-product facilities, and a risk-based approach for defining cleaning validation approaches for new products. Experience with biopharmaceutical manufacturing, automated cleaning processes (CIP and parts washers), and manual cleaning operations is also required.
Responsibilities
The Senior Cleaning Validation Engineer will serve as the lead for cross-functional teams, providing guidance during project planning, design, and development. This role involves writing and reviewing technical documentation, including cleaning cycle development reports, SOPs, and system lifecycle documentation, as well as creating and executing cleaning validation protocols and identifying and resolving non-conformances. The engineer will assist in preparing regulatory submissions, present validation findings to regulatory authorities during inspections, manage contractors performing system qualifications, and report project status to the leadership team.
Skills
Cleaning Validation
CIP
Parts Washers
Cleaning Studies
SOPs
Technical Documentation
Risk-Based Approach
Biopharmaceutical Manufacturing
Regulatory Submissions
System Qualifications
Gilead Sciences
Develops and commercializes biopharmaceuticals
About Gilead Sciences
Gilead Sciences focuses on discovering, developing, and commercializing medicines for various medical conditions, including HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular issues. The company conducts extensive research and development to create new therapies, which are then marketed to healthcare providers, hospitals, and pharmacies after receiving regulatory approval. Gilead differentiates itself from competitors through its strong commitment to R&D and strategic partnerships, such as with SAP Ariba, to enhance its operations and product offerings. The company's goal is to improve health equity and access to care globally, working with communities to ensure that its medicines reach those in need.
Key Metrics
Foster City, CaliforniaHeadquarters
1987Year Founded
$15,873.6MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees