Senior or Principal Process Engineer (API)

Veranova L P • West Deptford Township, NJ

70d • $120,000 - $130,000

About The Position

The Senior or 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 (MS&T). 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.

Requirements

• Bachelor’s degree in Chemical Engineering (required)
• 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.
• Familiarity with continuous improvement methodologies (Lean, Six Sigma).

Nice To Haves

• Master’s degree in Chemical Engineering or related field (preferred)
• PMP or equivalent project management certification (preferred).

Responsibilities

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

Benefits

• Comprehensive health & wellness benefits.
• Access to mental health resources and wellness programs.
• Generous PTO and holiday pay policies.
• Eligibility for performance-based bonuses.
• Attractive 401(k) Plan with company match.
• Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship.
• Tuition Assistance for Undergraduate and Graduate degree programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior