Senior Manager, Manufacturing Engineering
Senior Manager, Manufacturing Engineer
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 leadership and direction to engineers and contractors.
- Provides expert project management skills and experience.
- Manages programs 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.
- Ensures GMP training of all employees.
- Manages department operational areas.
- Manages multiple projects of significant complexity and risk. Manages machinery and equipment maintenance and operations functions.
- Evaluates design processes to modify machinery and equipment; approves estimated cost and designs layouts.
- Ensures that team personnel are trained and developed to meet changing company needs.
- Conduct design review as a subject matter expert (SME) with the equipment suppliers and design firms. Review content such as general arrangement drawings, PIDs, utility matrix, and automation layout.
- Generate master plan and guide the team to conduct testing/verification of process equipment or utility systems by following the latest risk-based C&Q approach.
- 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 (e.g. filler, isolator, lyophilizer).
Education & Experience:
- A minimum of eight (8) years of relevant experience with a BS or BA or related fields, OR a minimum of six (6) years of relevant experience with a MS, MA or MBA.
- Previous experience in biotech or pharmaceuticals industry.
- Previous experience in packaging, 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 junior engineers (contractors or FTEs).
- Automation Experience as it relates to automated equipment.
If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead