Manufacturing Engineer III

Pharmaceutical Manufacturing Engineering

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.

Job Responsibilities

• Manages project budgets and organizes resources according to team priorities and customer needs.

  Contributes to the development of new concepts, techniques, and standards.

• Ensures solutions are consistent with organization objectives.
• Provides technical expertise and direction to the project workstream teams and contractors.
• Evaluates design processes to modify machinery and equipment; approves estimated cost and designs layouts.
• Troubleshoot process equipment issues potentially involving utilities and automation.
• Provides expert project management skills and experience.
• Manages projects and processes to ensure high quality of operations, equipment maintenance, and compliance with codes, Current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs)
• Interacts with contractors and/or vendors on routine machinery and equipment administration matters.
• May hire, train, evaluate, and review personnel.
• Lead design, testing, installation, and qualification activities.
• Lead operational go-live activities.
• Lead multiple projects of significant complexity and risk.
• Ensures that team personnel are trained and developed to meet changing company needs.
• Softskill:
  • Humble/smart/passion. 
  • Doesn’t mind rolling up the sleeves (boots on the floor to get things done).

Knowledge & Skills:

• Demonstrates extensive understanding and application of process engineering principles, concepts, and practices, and standards.
• Demonstrates proficiency in current Good Manufacturing Practices (GMPs) and safety regulations.
• Demonstrates excellent verbal, written, and interpersonal communication skills.
• Proficient in Microsoft Office applications.
• Demonstrates expertise in project management
• Understands the compliance expectation for aseptic operation and design principals for aseptic processing equipment

Education & Experience:

• A minimum of eight (8) years of relevant experience and a BS or BA or related fields, OR a minimum of six (6) years of relevant experience and a MS, MA or MBA. 
• Previous experience in biotech or pharmaceuticals industry.
• Previous experience in isolator technology and aseptic operation equipment (e.g.

  filler, isolator, lyophilizer).

• Previous experience in managing engineering capital projects from design/build to installation/startup.
• Experience in managing contractors or project workstream teams (e.g.

  QA, Mfg, QC, Validation, etc).

• Automation Experience as it relates to automated equipment.

About Gilead

Gilead Sciences, Inc.

is a research-based biopharmaceutical 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.

Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.