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.
- 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