Job Description
Work Schedule First Shift (Days) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP)
Safety Standards, Cleanroom:
no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description How will you make an impact? As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. The Staff Engineer, Media Fill plays a critical role in supporting sterile/aseptic manufacturing operations by leading media fill (aseptic process simulation) programs. This role ensures processes remain in a validated state and compliant with global regulatory expectations. What will you do? Lead the design and execution of media fill (APS) studies for aseptic manufacturing processes Author and review validation protocols, reports, and risk assessments Support investigations, deviations, and CAPAs related to media fills and aseptic processes Partner cross-functionally with Manufacturing, Quality, and Regulatory teams Ensure compliance with cGMP, FDA, EMA, and global regulatory requirements Drive continuous improvement initiatives in validation and contamination control strategies How will you get here? Education:
Bachelor's degree in Engineering, Life Sciences, or related field Experience:
8+ years of experience in pharmaceutical/biotech validation Strong experience with aseptic processing and media fill execution (required) Experience in sterile manufacturing environments (required) Knowledge, Skills, Abilities:
Deep understanding of aseptic processing and contamination control Strong knowledge of cGMP and regulatory expectations Technical writing expertise (validation protocols and reports) Ability to lead complex validation projects independently Strong collaboration and communication skills Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
