Manufacturing Technician III - Downstream
Manufacturing Technician III - Downstream
United States - California - Oceanside
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Manufacturing Technician III- Downstream
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Downstream Manufacturing, Oceanside
- The Manufacturing Technician III is responsible for the operation of large and small scale chromatography columns and skids, viral filtration and ultrafiltration/diafiltration skids, as well as all related equipment and systems necessary to clean, configure, sanitize/sterilize and maintain said equipment.
- Operation and practical knowledge of glass washers, autoclaves, filters, pumps and analytical equipment to support and monitor the process is expected.
- Safety and Compliance are the two primary objectives of manufacturing operations.
- Reports to Team Lead on a regular basis on line performance and reports any issues that need to be resolved.
- Expected duties also include planning and executing the safe and efficient operation of assigned processes, Good Documentation Practices, timely communication of deviations, incidents and/or safety concerns and all relevant housekeeping duties to ensure the work areas are kept to a high level of cleanliness and inspection readiness.
- Involvement in planning and full execution/proper documentation of all operations associated with:
- Buffer preparation
- Protein Purification by means of column chromatography, Viral Filtration and UFDF
- Clean in Place (CIP) and Steam in Place (SIP) of fixed tanks/vessels and portable equipment and Clean out of Place (COP)/Glasswash of misc. parts and equipment
- Proficiency and routine maintenance of analytical equipment including but not limited to: pH/conductivity meters, bioanalyzers, osmometers, benchtop centrifuges, cell counters and microscopes
- Experience with DeltaV Automation Systems and Unicorn System Control or equivalent
- Aseptic Processing experience and knowledge required.
- Knowledge of quality systems, validation principles, regulatory and ICH guidelines and multi-product controls required
- Background or understanding of Lean concepts (Kaizen, 5S, KanBan) desired
- Works under demanding production schedules and strict compliance/quality requirements
- Coordination with support groups including, but not limited to: Process Development, Quality Assurance and Control, Calibration, Maintenance, Validation, and Materials Management as a Manufacturing representative
- Ability to work independently and in teams, proactive and self-managing, proven problem solving as well as a detailed and organized approach are key components to the success of this candidate.
- Must be flexible to work day, swing, or night shifts, and/or weekends
Knowledge, Experience, and Skills:
- Knowledge of written Standard Operating Procedures (SOPs) and Master Batch Records
- Good verbal, written, and interpersonal communication skills are required.
- Working knowledge in Microsoft Office applications and administrative policies
- Ability to follow direction and work under minimal supervision
- Demonstrates capability in organizing more complex activities in a manufacturing process
- A minimum 3 years of relevant experience, HS Diploma and a Certificate to FETAC level 6 (GSL)
- 0 - 2 years of relevant experience with a Bachelors degree in engineering or scientific discipline
- Prior experience in a Biologics cGMP related industry is required.
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact email@example.com for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Oceanside/Manufacturing-Technician-III---Downstream_R0016446
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