Senior Process Engineer III, Biologics Technical Manufacturing & Operations

Location
Oceanside, CA, US
Posted
Oct 22, 2020
Ref
2027675
Required Education
Bachelors Degree
Position Type
Full time
Senior Process Engineer III, Biologics Technical Manufacturing & Operations
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. Gilead’s 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 company’s five core values. That’s 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


Senior Manufacturing Engineer III, Biologics Technical Manufacturing & Operations

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.

Gilead has an opportunity for an experienced Senior Process Engineer at our Oceanside biologics facility in Southern California. We are seeking motivated, team-oriented individuals with expertise in Process Engineering and technical transfer of recombinant proteins. Reporting to the Director of Process Engineering and Technical Operations, you will have the opportunity to lead equipment and facility based projects and helping to ensure the success of internal manufacturing campaigns.

Specific responsibilities and skills for position:
  • Responsible for the design, modification, procurement, vendor coordination, project management, change management ownership and budget for facility and manufacturing equipment projects
  • Collaborate with the Maintenance, Process Development, Manufacturing, Validation, Automation and Technical Operations to ensure the successful manufacturing of biologic processes
  • Identify areas for improvement or optimization, lead implementation of best practices, and/or present data to applicable departments on the outcome of investigations or optimization initiatives
  • Contribute to and/or lead technical investigations of equipment deviations and troubleshooting
  • Lead and participate in cross-functional projects with limited direction
  • Manage programs and processes to ensure high quality of operations, equipment and compliance with codes and current Good Manufacturing Practices and Good Engineering Practices
  • Develop solutions to a wide range of complex problems which require the regular use of ingenuity and innovation
  • Implement and integrate equipment and systems with minimal interruption to manufacturing operations
  • Write and/or implement deviations, change managements and CAPAs as needed
  • Independently resolves a wide variety of issues of complex scope
  • Independently manage assigned projects through completion
  • Provide experienced and expert guidance to internal teams
  • Interface with regulatory agencies as required and participate/support internal and external audits


Essential Duties and Job Functions:
  • Demonstrates a commitment to compliance and a thorough knowledge of current Good Manufacturing Practices (cGMPs)
  • Works on non-routine to complex problems, projects and assignments where analysis of data, procedures or operations requires evaluation of multiple factors before taking action


Specific Education & Experience Requirements:
  • 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 biotech or pharmaceuticals industry.
  • Has previous experience in engineering in highly regulated manufacturing environments.


Knowledge:
  • Demonstrates in-depth knowledge of state of the art principles
  • Demonstrates in-depth knowledge of current Good Manufacturing Practices (GMPs).
  • Demonstrates extensive knowledge of industry practices.
  • Demonstrates excellent verbal, technical writing, and interpersonal communication skills.
  • Has proven analytical and conceptual skills.
  • Demonstrates ability to effectively manage multiple projects/priorities.
  • Demonstrates ability to understand key business processes and business areas
  • Demonstrates expertise in project management
  • Demonstrates the ability to work effectively in cross-functional teams


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 careers@gilead.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/Senior-Manufacturing-Engineer-III--Biologics-Technical-Manufacturing---Operations_R0015477-1

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