Job Description

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.

Specific Responsibilities:

Serve as Subject Matter Expert on reliability aspects of aseptic fill/finish equipment

Collaborate closely with equipment engineers, manufacturing personnel, technical services scientists, validation engineers, automation engineers and quality staff to identify and resolve potential production risks associated with operation of GxP equipment.

Work in a matrix environment as a technical lead to achieve operational excellence on fill/finish processes.

Identify process and equipment risks by enhanced FMEA tools.

Serve as a key member of technology transfer team to identify and address any production equipment gaps.

Proactively assess production plans on new filling lines and identify and mitigate potential risks by leading engineering studies.

Be able to articulate complex manufacturing and technical issues to senior management.

Work with equipment suppliers to identify best-in-class operational and maintenance practices for pharmaceutical manufacturing equipment.

Knowledge & Skills

Deep expertise in sterile pharmaceutical fill/finish equipment including isolators, filling systems, robotics, freeze-dryers, and associated systems

Demonstrated skills in diagnosis of reliability issues, using new tools and existing failure-mode data.

Understanding of complex formulation requirements such as biologics, long-acting release formulations and colloidal systems is highly desired.

Expertise in modern sterile pharma equipment design, build, integration and operation. 

Education & Experience

10+ years of relevant experience and a BS or related fields.

8+ years of relevant experience and a MA or MBA.

Has previous experience in engineering in highly regulated manufacturing environments.

Knowledge of the process engineering and reliability engineering principles.

Previous hands-on experience supporting and executing process development, engineering, and manufacturing projects involving complex manufacturing equipment.

Experience working with regulatory agencies (FDA and EMEA) for biologics or pharmaceuticals.

Knowledge of scientific and engineering principles in the biopharmaceutical industry.

Experience with manufacturing equipment that are integrated with site Process Control System (PCS).

Familiarity with robotics, isolators and aseptic filling systems.