Principal Engineer/ Principal MFG Scientist, Mfg Sciences

About This Role

As a Principal Engineer / Principal Manufacturing Scientist within the Manufacturing Sciences team, you will be pivotal in providing technical expertise for clinical and commercial manufacturing campaigns at our Parenteral Facility Drug Product site. This role requires you to leverage your knowledge in fill/finish, visual inspection, and packaging, serving as a key leader and Subject Matter Expert in investigations and project implementation. By driving process improvements and technology transfers, you will significantly contribute to the success of manufacturing operations. Your efforts will enhance the capabilities of our seasoned manufacturing personnel and ultimately bring value to the business while ensuring compliance with regulatory standards. You will collaborate with cross-functional teams, interface with regulatory agencies, and support continuous advancement in manufacturing processes.

What You'll Do

• Lead investigations and act as the point of contact for the Manufacturing Technical Organization.
• Develop an in-depth training program to enhance process understanding for seasoned manufacturing personnel.
• Analyze data related to unit operations and establish a platform for trending programs.
• Manage technical projects that provide value to the RTP Pharma site, ensuring process improvements and transfers.
• Communicate continuous improvement activities, deviations, technology transfer deliverable schedules, and metrics to management and partner departments.
• Facilitate meetings with various stakeholders and report program statuses to management through effective project management.
• Actively pursue and implement technical improvement projects through the global change control process.
• Interface with regulatory agencies during inspections, presenting technical reports and operational activities.

• Bachelors degree in Engineering or relevant scientific/technical discipline with at minimum 10 years of relevant experience is required OR
• Masters degree in Engineering or relevant scientific/technical discipline with at minimum 8 years of direct experience OR
• Ph.D. in Engineering or relevant scientific/technical discipline with at minimum 6 years of direct experience
• In-depth knowledge in technical understanding of Parenteral Filling Operations (e.g. Filling Isolator, Lyophilizer, Visual Inspection) including transfer of such processes into full-scale drug product manufacturing facilities.
• Ability to work independently and collaboratively in large cross-functional groups.
• Effective communication and project management skills for leadership in technology transfer projects.
• Proficiency in analyzing scientific datasets with strong analytical and written skills.
• Ability to lead and work well in individual and leadership roles.
• Knowledge of cGMP, FDA/EMA regulations, and Process Performance Qualification requirements.

• Experience with regulatory inspections and technical report management.
• Strong background in data analysis for process improvements.
• Ability to develop and implement training programs for manufacturing personnel.
• Six Sigma Black Belt Certification is strongly preferred.

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation