Senior Engineer, Manufacturing Science and Technology

Novartis • Durham, CA

2d • Onsite

About The Position

The Senior Engineer, Manufacturing Science and Technology – ADP, is responsible for leading process introduction and improvement activities for the drug product manufacturing processes used to fill sterile products at the Durham, NC campus.

Requirements

• Bachelor of Science degree in biochemistry, chemical engineering, bioengineering, or related technical field and at least 6 years of experience in support of biopharmaceutical manufacturing OR Master of Science degree in biochemistry, chemical engineering, bioengineering, or related technical field and at least 4 years of experience in support of biopharmaceutical manufacturing OR PhD in biochemistry, chemical engineering, bioengineering, or related technical field and at least 2 years of experience in support of biopharmaceutical manufacturing.
• Excellent oral and written communication skills.

Nice To Haves

• 6 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in aseptic fill/finish and/or technology transfer.
• Familiar with global regulations on devices, drugs, validation/qualification requirements.
• Strong technical writing ability.
• Proven ability to effectively lead and participate on teams.
• May travel up to 10% - 15%.

Responsibilities

• Collection and interpretation of continued process verification data and collaboration with other departments on manufacturing related issues to drive resolution and process improvements.
• Serves as a scientific and technical lead for process-related issues and investigations at the facility.
• Partners with manufacturing to meet the production schedule, ensure commercial supply and uphold quality standards.
• Performs trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift.
• Implements potential process improvements in conjunction with operations.
• Participates in start-up efforts of new equipment, software or processes in manufacturing.
• Assists in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes.
• Provides technical/scientific support on project deliverables, i.e. remediation initiatives, plan reports.
• Partners with Technology Development and/or network sending sites to support tech transfer of new products and processes and ensure smooth transition from process development to GMP manufacturing.
• Looks for opportunities to implement operational excellence and continuous improvement.
• Partners with Quality to ensure a compliant manufacturing environment.
• Assists the technical operations team to resolve any issues related to production.
• Completion of requisite training, as well as applicable policies and procedures, related to the job function is an expectation to support ongoing manufacturing support.
• Other related duties as assigned.

Benefits

• US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits.
• In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees