Senior Principal Engineer (API)

Role Overview

The Senior Principal Engineer is a technical leadership role responsible for overseeing engineering activities related to the development, validation, and lifecycle management of Active Pharmaceutical Ingredient (API) manufacturing processes. This role requires deep expertise in pharmaceutical engineering, regulatory compliance, and cross-functional collaboration. The individual may lead and mentor a team of engineers while driving continuous improvement, ensuring product quality, and supporting business objectives.

Core Responsibilities

Technical Leadership & Engineering Oversight

• Lead and provide strategic direction for engineering activities supporting API manufacturing processes.
• Mentor and manage a team of engineers, fostering technical growth and high performance.
• Serve as a subject matter expert in process engineering and validation.

Process Validation (API)

• Design, execute, and review process validation protocols and reports for API manufacturing.
• Ensure validation activities comply with regulatory requirements and internal quality standards.
• Support lifecycle process validation, including continued process verification.

Annual Product Review (APR)

• Lead and contribute to Annual Product Review activities, ensuring comprehensive evaluation of process performance and product quality.
• Identify trends, recommend improvements, and ensure timely completion of APR documentation.

New Product Introduction (NPI)

• Provide engineering support for new product introductions, including process scale-up, technology transfer, and commercialization.
• Collaborate with R&D, Quality, and Manufacturing teams to ensure smooth product launches.
• Work closely with Contract Development and Manufacturing Organizations (CDMOs) for process transfer, validation, and ongoing production support.
• Ensure alignment with internal standards and regulatory expectations.

Client Complaints & Investigations

• Lead or support investigations related to client complaints, deviations, and non-conformances.
• Identify root causes and implement effective corrective and preventive actions (CAPA).

Process Monitoring Programs

• Develop and maintain process monitoring strategies to ensure consistent product quality and process performance.
• Utilize statistical tools and data analysis to identify trends and drive continuous improvement.

Regulatory Inspections & Compliance

• Serve as a key representative during regulatory inspections and audits.
• Ensure engineering systems and documentation comply with cGMP and global regulatory requirements.
• Support responses to regulatory observations and commitments.

Project Management

• Lead and manage cross-functional engineering projects, ensuring delivery on time and within budget.
• Develop project plans, allocate resources, and track progress against milestones.
• Drive risk management and mitigation strategies.

Qualifications

• Bachelor’s degree in Chemical Engineering (required)
• Master’s degree in Chemical Engineering or related field (preferred)
• Minimum of 10+ years of experience in the pharmaceutical or biopharmaceutical industry, with a strong focus on API manufacturing.
• Proven experience in process validation, regulatory compliance, and engineering leadership.
• Experience working with CDMOs and external partners.
• In-depth knowledge of cGMP regulations and industry standards.
• Strong understanding of process validation, process design, and scale-up.
• Experience with process monitoring tools and statistical analysis.
• Demonstrated leadership and team management experience.
• PMP or equivalent project management certification (preferred).
• Familiarity with continuous improvement methodologies (Lean, Six Sigma).

Salary Range

$120,000-$130,000 annual base salary.

This range represents a good-faith estimate of the compensation we expect to offer for this position at the time of posting. Actual compensation will be based on factors such as relevant experience, skills, qualifications, and internal equity. In exceptional cases, compensation may exceed the stated range.

All full-time employees are eligible to participate in our annual incentive bonus program. Bonus targets vary by career level and are…